Active substance: paracetamol (IV formulation) Procedure ...Procedure no.: PSUSA/00002311/201605 ....
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30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5525 Send a question via our website www.ema.europa.eu/contact © European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged. 1 December 2016 EMA/819150/2016 Human Medicines Evaluation Division List of nationally authorised medicinal products Active substance: paracetamol (IV formulation) Procedure no.: PSUSA/00002311/201605
Transcript of Active substance: paracetamol (IV formulation) Procedure ...Procedure no.: PSUSA/00002311/201605 ....
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
An agency of the European Union
Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5525 Send a question via our website www.ema.europa.eu/contact
© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.
1 December 2016 EMA/819150/2016 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: paracetamol (IV formulation)
Procedure no.: PSUSA/00002311/201605
List of nationally authorised medicinal products EMA/819150/2016 Page 2/40
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
ALGOCIT, Διάλυμα για έγχυση 10mg/ml
not available 13422/17-02-2009 DEMO ABEE GR
Apotel 10 mg/ml Solución para perfusión EFG
NL/H/2857/001 80007 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
ES
Apotel 10 mg/ml, oplossing voor infusie
NL/H/2857/001 RVG 113095 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
NL
Apotel, infusionsvreske, opl~sning
NL/H/2857/001 54977 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
DK
Apotel, solução para perfusão, 150mg/ml
not available 5319041 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
PT
APOTEL® max Διάλυμα για έγχυση 1 g/100ml
not available 21966 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
CY
APOTEL® max Διάλυμα για έγχυση 1 g/100ml
not available 71403/13 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
APOTEL® Διάλυμα για ενδοφλέβια έγχυση 1 g/6,7ml AMP
not available 43355/12/20.02.2013 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
APOTEL®, Διάλυμα για ενδοφλέβια έγχυση 1 g/6,7ml AMP
not available S00546 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
CY
Exopon 10 mg/ml lnfusionslosung
NL/H/2857/001 93352.00.00 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
DE
Exopon 10 mg/ml soluzione per infusione
NL/H/2857/001 043471046 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
IT
Exopon 10 mg/ml soluzione per infusione
NL/H/2857/001 043471010 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
IT
List of nationally authorised medicinal products EMA/819150/2016 Page 3/40
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Exopon 10 mg/ml soluzione per infusione
NL/H/2857/001 043471022 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
IT
Exopon 10 mg/ml soluzione per infusione
NL/H/2857/001 043471034 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
IT
Exopon 10mg/ml infusionsvätska, lösning
NL/H/2857/001 51968 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
SE
EXOPON® Διάλυμα για έγχυση 1 g/100ml
not available 54138 IOULIA AND IRENE TSETI PHARMACEUTICAL LABORATORIES S.A.
GR
HELPORAL® not available 41623/12 MEDICUS A.E GR Lekadol 10 mg/ml otopina za infuziju
/ UP/I-530-09/12-01/358 SANDOZ D.O.O. HR
Paracetamol ”B. Braun”, infusionsvæske, opløsning
DE/H/3084/001 48517 B.BRAUN MELSUNGEN AG DK
Paracetamol ”Fresenius Kabi”, infusionsvæske, opløsning
DE/H/2511/001 45499 FRESENIUS KABI AB DK
Paracetamol ”Panpharma”, infusionsvæske, opløsning
FR/H/0355/001 43307 PANMEDICA DK
Paracetamol ”Panpharma”, infusionsvæske, opløsning
FR/H/0355/001 43307 PANMEDICA DK
Paracetamol ”Panpharma”, infusionsvæske, opløsning
FR/H/0355/001 43307 PANMEDICA DK
Paracetamol ”Panpharma”, infusionsvæske, opløsning
FR/H/0355/001 43307 PANMEDICA DK
Paracetamol ”Panpharma”, infusionsvæske, opløsning
FR/H/0355/001 43307 PANMEDICA DK
Paracetamol ”Panpharma”, infusionsvæske, opløsning
FR/H/0355/001 43307 PANMEDICA DK
Paracetamol ”Panpharma”, infusionsvæske, opløsning
FR/H/0355/001 43307 PANMEDICA DK
Paracetamol ”Panpharma”, infusionsvæske, opløsning
FR/H/0355/001 43307 PANMEDICA DK
List of nationally authorised medicinal products EMA/819150/2016 Page 4/40
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Paracetamol ”Panpharma”, infusionsvæske, opløsning
FR/H/0355/001 43307 PANMEDICA DK
Paracetamol ”Panpharma”, infusionsvæske, opløsning
FR/H/0355/001 43307 PANMEDICA DK
Paracetamol ”Panpharma”, infusionsvæske, opløsning
FR/H/0355/001 43307 PANMEDICA DK
Paracetamol ”Panpharma”, infusionsvæske, opløsning
FR/H/0355/001 43307 PANMEDICA DK
Paracetamol ”Panpharma”, infusionsvæske, opløsning
FR/H/0355/001 43307 PANMEDICA DK
Paracetamol ”Panpharma”, infusionsvæske, opløsning
FR/H/0355/001 43307 PANMEDICA DK
Paracetamol ”Panpharma”, infusionsvæske, opløsning
FR/H/0355/001 43307 PANMEDICA DK
Paracetamol 10 mg/ ml solution for infusion
PT/H/1003/001 PL 24598/0028 NORIDEM ENTERPRISES LTD UK
Paracetamol 10 mg/ml solution for infusion
DE/H/2511/001 PA 0566/057/002 FRESENIUS KABI LIMITED IE
Paracetamol 10 mg/ml solution for infusion
DE/H/2511/001 PA 0566/057/001 FRESENIUS KABI LIMITED IE
Paracetamol 10 mg/ml Solution for Infusion
DE/H/3248/001 PA 711/228/001 ROWEX LTD IE
Paracetamol 10 mg/ml Solution for Infusion
not available PL30306/0391 ACTAVIS GROUP PTC EHF. UK
Paracetamol 10 mg/ml solution for infusion
DE/H/2511/001 PL 08828/0226 FRESENIUS KABI LIMITED UK
Paracetamol 10 mg/ml Solution for Infusion
DE/H/3248/001 PL 04416/1388 SANDOZ LTD UK
Paracetamol 10 mg/ml solution for infusion
DE/H/3084/001 PL 03551/0128 B.BRAUN MELSUNGEN AG UK
Paracetamol 10 mg/ml, solution for infusion
DE/H/3248/001 MA939/04401 1 A PHARMA GMBH MT
Paracetamol 10 mg/ml, solution for infusion
not available PL 20117/0204 MORNINGSIDE HEALTHCARE LTD
UK
Paracetamol 10mg/ml solution for infusion
FR/H/0472/001 PA 931/10/1 MACO PHARMA (UK) LTD IE
List of nationally authorised medicinal products EMA/819150/2016 Page 5/40
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Paracetamol 10mg/ml solution for infusion
DE/H/3084/001/DC PA 0736/035/001 B.BRAUN MELSUNGEN AG IE
Paracetamol 10mg/ml solution for infusion
FR/H/0472/001 PL12580/0021 MACO PHARMA (UK) LTD UK
Paracetamol AB 10 mg/ml oplossing voor infusie
DE/H/2210/001 BE368952 AUROBINDO PHARMA B.V. BE
Paracetamol AB 10 mg/ml solution pour perfusion
DE/H/2210/001 2010110047 AUROBINDO PHARMA B.V. LU
Paracetamol Accord 10 mg/ml solução para perfusão
PT/H/1221/01 5274006 ACCORD HEALTHCARE LIMITED
PT
Paracetamol Accord 10 mg/ml solução para perfusão
PT/H/1221/01 5274014 ACCORD HEALTHCARE LIMITED
PT
Paracetamol Accord 10 mg/ml solução para perfusão
PT/H/1221/01 5335179 ACCORD HEALTHCARE LIMITED
PT
Paracetamol Accord 10 mg/ml solução para perfusão
PT/H/1221/01 5335203 ACCORD HEALTHCARE LIMITED
PT
Paracetamol Accord 10 mg/ml solução para perfusão
PT/H/1221/01 5335211 ACCORD HEALTHCARE LIMITED
PT
Paracetamol Accord 10 mg/ml solução para perfusão
PT/H/1221/01 5678040 ACCORD HEALTHCARE LIMITED
PT
Paracetamol Accord 10 mg/ml solución para perfusión EFG
PT/H/1221/01 72112 ACCORD HEALTHCARE S.L.U.
ES
Paracetamol Actavis 10 mg/ml Infusionslösung
DK/H/2668/001 1-29587 ACTAVIS GROUP PTC EHF. AT
Paracetamol Actavis 10 mg/ml infuusioneste, liuos
DK/H/2668/001 27081 ACTAVIS GROUP PTC EHF. FI
Paracetamol Actavis 10 mg/ml oldatos infúzió
DK/H/2668/001 OGYI-T-21752/01,07,02 ACTAVIS GROUP PTC EHF. HU
List of nationally authorised medicinal products EMA/819150/2016 Page 6/40
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
PARACETAMOL ACTAVIS 10 MG/ML SOLUCIÓN PARA PERFUSIÓN EFG
DE/H/2210/001/DC 72.214 ACTAVIS GROUP PTC EHF. ES
Paracetamol Actavis 10 mg/ml solutie perfuzabila
DK/H/2668/001 5854/2013/01-02-03 ACTAVIS GROUP PTC EHF. RO
Paracetamol Actavis 10mg/1ml solution for infusion
DK/H/2668/001 PA 1380/93/1 ACTAVIS GROUP PTC EHF. IE
Paracetamol Actavis 10mg/ml solution for infusion
DK/H/2668/001 20100218 ACTAVIS GROUP PTC EHF. BG
Paracetamol Actavis 10mg/ml solution for infusion
DK/H/2668/001 09-6545 ACTAVIS GROUP PTC EHF. NO
Paracetamol Actavis 10mg/ml solution for infusion
DK/H/2668/001 41791 ACTAVIS GROUP PTC EHF. SE
Paracetamol Amneal 10 mg/ml Infusionslösung
not available 75058.00.00 AMNEAL PHARMA EUROPE LIMITED
DE
Paracetamol Amneal 10 mg/ml Infusionslösung
not available 75058.00.00 AMNEAL PHARMA EUROPE LIMITED
DE
PARACETAMOL ARROW 10 mg/ml, solution pour perfusion
not available NL 37203 ARROW GENERIQUES FR
PARACETAMOL ARROW 10 mg/ml, solution pour perfusion
not available NL 37203 ARROW GENERIQUES FR
Paracetamol Aurobindo 10 mg/ml, oplossing voor infusie
DE/H/2210/001 RVG 103994 AUROBINDO PHARMA B.V. NL
Paracetamol Aurovitas 10 mg/ml Solução para perfusão
DE/H/2210/001 5280938 AUROVITAS UNIPESSOAL, LDA.
PT
Paracetamol Aurovitas 10 mg/ml Solução para perfusão
DE/H/2210/001 5280946 AUROVITAS UNIPESSOAL, LDA.
PT
List of nationally authorised medicinal products EMA/819150/2016 Page 7/40
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Paracetamol Aurovitas 10 mg/ml Solução para perfusão
DE/H/2210/001 5356837 AUROVITAS UNIPESSOAL, LDA.
PT
PARACETAMOL B BRAUN 10 mg/ml, solution pour perfusion
DE/H/3084/001 NL 40 875 B.BRAUN MELSUNGEN AG FR
Paracetamol B. Braun 10 mg/ml Infusionslösung
DE/H/3084/001 2012090064 B.BRAUN MELSUNGEN AG LU
Paracetamol B. Braun 10 mg/ml Infusionslösung.
DE/H/3084/001 1-31280 B.BRAUN MELSUNGEN AG AT
Paracetamol B. Braun 10 mg/ml Infusionslösung.
DE/H/3084/001 83987.00.00 B.BRAUN MELSUNGEN AG DE
Paracetamol B. Braun 10 mg/ml infusionsvätska, lösning
DE/H/3084/001 45748 B.BRAUN MELSUNGEN AG SE
Paracetamol B. Braun 10 mg/ml infusioonilahus
DE/H/3084/001 777112 B.BRAUN MELSUNGEN AG EE
Paracetamol B. Braun 10 mg/ml infusjonsvæske, oppløsning
DE/H/3084/001/DC 11-8174 B.BRAUN MELSUNGEN AG NO
Paracetamol B. Braun 10 mg/ml infuusioneste, liuos
DE/H/3084/001/DC 29564 B.BRAUN MELSUNGEN AG FI
Paracetamol B. Braun 10 mg/ml infuzinis tirpalas
DE/H/3084/001/DC LT/1/12/2954/001 B.BRAUN MELSUNGEN AG LT
Paracetamol B. Braun 10 mg/ml infuzinis tirpalas
DE/H/3084/001/DC LT/1/12/2954/003 B.BRAUN MELSUNGEN AG LT
Paracetamol B. Braun 10 mg/ml infuzinis tirpalas
DE/H/3084/001/DC LT/1/12/2954/002 B.BRAUN MELSUNGEN AG LT
Paracetamol B. Braun 10 mg/ml infuzní roztok
DE/H/3084/001/DC 07/221/12-C B.BRAUN MELSUNGEN AG CZ
Paracetamol B. Braun 10 mg/ml infúzny roztok
DE/H/3084/001 07/0159/12-S B.BRAUN MELSUNGEN AG SK
Paracetamol B. Braun 10 mg/ml oplossing voor infusie
DE/H/3084/001/DC BE416175 B.BRAUN MELSUNGEN AG BE
Paracetamol B. Braun 10 mg/ml oplossing voor infusie
DE/H/3084/001/DC BE416184 B.BRAUN MELSUNGEN AG BE
List of nationally authorised medicinal products EMA/819150/2016 Page 8/40
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Paracetamol B. Braun 10 mg/ml oplossing voor infusie
DE/H/3084/001 BE464417 B.BRAUN MELSUNGEN AG BE
Paracetamol B. Braun 10 mg/ml raztopina za infundiranje
DE/H/3084/001 H/12/01225/002 B.BRAUN MEDICAL, S.A. SI
Paracetamol B. Braun 10 mg/ml raztopina za infundiranje
DE/H/3084/001 H/12/01225/003 B.BRAUN MEDICAL, S.A. SI
Paracetamol B. Braun 10 mg/ml raztopina za infundiranje
DE/H/3084/001 H/12/01225/001 B.BRAUN MEDICAL, S.A. SI
Paracetamol B. Braun 10 mg/ml šķīdums infūzijām
DE/H/3084/001 12-0052 B.BRAUN MELSUNGEN AG LV
Paracetamol B. Braun 10 mg/ml solução para perfusão
DE/H/3084/001 5442967 B.BRAUN MELSUNGEN AG PT
Paracetamol B. Braun 10 mg/ml solução para perfusão
DE/H/3084/001 5442975 B.BRAUN MELSUNGEN AG PT
Paracetamol B. Braun 10 mg/ml solución para perfusión EFG
DE/H/3084/001 75594 B.BRAUN MELSUNGEN AG ES
Paracetamol B. Braun 10 mg/ml soluţie perfuzabilă
DE/H/3084/001/DC 4714/2012/01-02 B.BRAUN MELSUNGEN AG RO
Paracetamol B. Braun 10 mg/ml solution pour perfusion
DE/H/3084/001/DC BE416175 B.BRAUN MELSUNGEN AG BE
Paracetamol B. Braun 10 mg/ml solution pour perfusion
DE/H/3084/001/DC BE416184 B.BRAUN MELSUNGEN AG BE
Paracetamol B. Braun 10 mg/ml solution pour perfusion
DE/H/3084/001 BE464417 B.BRAUN MELSUNGEN AG BE
Paracetamol B. Braun 10 mg/ml, oplossing voor infusie
DE/H/3084/001 RVG 109193 B.BRAUN MELSUNGEN AG NL
List of nationally authorised medicinal products EMA/819150/2016 Page 9/40
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Paracetamol B. Braun, 10 mg/ml, roztwór do infuzji
DE/H/3084/001 20317 B.BRAUN MELSUNGEN AG PL
Paracetamol B.Braun 10 mg/ml otopina za infuziju
not available UP/I-530-09/13-01/02 B.BRAUN ADRIA D.O.O. HR
Paracetamol Color 10 mg/ml Solução para perfusão
not available 5368758 COLOR PHARMA, LDA. PT
Paracetamol Combino Pharm 10 mg/ml solução para perfusão
PT/H/1465/01/DC NA COMBINO PHARM S.L PT
Paracetamol Combino Pharm 10 mg/ml solución para perfusión
PT/H/1465/01/DC 80682 COMBINO PHARM S.L ES
Paracetamol Farmoz 10 mg/ml solução para perfusão
not available 5377460 FARMOZ - SOCIEDADE TÉCNICO MEDICINAL, S.A.
PT
Paracetamol Farmoz 10 mg/ml solução para perfusão
not available 5377478 FARMOZ - SOCIEDADE TÉCNICO MEDICINAL, S.A.
PT
Paracetamol Farmoz 10 mg/ml solução para perfusão
not available 5377502 FARMOZ - SOCIEDADE TÉCNICO MEDICINAL, S.A.
PT
Paracetamol Farmoz 10 mg/ml solução para perfusão
not available 5377510 FARMOZ - SOCIEDADE TÉCNICO MEDICINAL, S.A.
PT
Paracetamol Farmoz 10 mg/ml solução para perfusão
not available 5377460 FARMOZ - SOCIEDADE TÉCNICO MEDICINAL, S.A.
PT
Paracetamol Farmoz 10 mg/ml solução para perfusão
not available 5377478 FARMOZ - SOCIEDADE TÉCNICO MEDICINAL, S.A.
PT
Paracetamol Farmoz 10 mg/ml solução para perfusão
not available 5377502 FARMOZ - SOCIEDADE TÉCNICO MEDICINAL, S.A.
PT
Paracetamol Farmoz 10 mg/ml solução para perfusão
not available 5377510 FARMOZ - SOCIEDADE TÉCNICO MEDICINAL, S.A.
PT
List of nationally authorised medicinal products EMA/819150/2016 Page 10/40
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Paracetamol Fresenius Kabi 10 mg/ml Infusionslösung
DE/H/2511/001 BE379775 FRESENIUS KABI NV/SA BE
Paracetamol Fresenius Kabi 10 mg/ml Infusionslösung
DE/H/2511/001 BE379784 FRESENIUS KABI NV/SA BE
Paracetamol Fresenius Kabi 10 mg/ml Infusionslösung
DE/H/2511/001 BE442181 FRESENIUS KABI NV/SA BE
Paracetamol Fresenius Kabi 10 mg/ml Infusionslösung
DE/H/2511/001 BE442197 FRESENIUS KABI NV/SA BE
Paracetamol Fresenius Kabi 10 mg/ml infusionsvätska, lösning
DE/H/2511/001 42920 FRESENIUS KABI AB SE
Paracetamol Fresenius Kabi 10 mg/ml infusjonsvæske, oppløsning
DE/H/2511/001 09-6966 FRESENIUS KABI NORGE AS NO
Paracetamol Fresenius Kabi 10 mg/ml infuusioneste, liuos
DE/H/2511/001 27825 FRESENIUS KABI AB FI
Paracetamol Fresenius Kabi 10 mg/ml oplossing voor infusie
DE/H/2511/001 BE379775 FRESENIUS KABI NV/SA BE
Paracetamol Fresenius Kabi 10 mg/ml oplossing voor infusie
DE/H/2511/001 BE379784 FRESENIUS KABI NV/SA BE
Paracetamol Fresenius Kabi 10 mg/ml oplossing voor infusie
DE/H/2511/001 BE442181 FRESENIUS KABI NV/SA BE
Paracetamol Fresenius Kabi 10 mg/ml oplossing voor infusie
DE/H/2511/001 BE442197 FRESENIUS KABI NV/SA BE
Paracetamol Fresenius Kabi 10 mg/ml oplossing voor infusie
DE/H/2511/001 RVG 105747 FRESENIUS KABI NEDERLAND B.V.
NL
Paracetamol Fresenius Kabi 10 mg/ml solution pour perfusion
DE/H/2511/001 BE379775 FRESENIUS KABI NV/SA BE
List of nationally authorised medicinal products EMA/819150/2016 Page 11/40
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Paracetamol Fresenius Kabi 10 mg/ml solution pour perfusion
DE/H/2511/001 BE379784 FRESENIUS KABI NV/SA BE
Paracetamol Fresenius Kabi 10 mg/ml solution pour perfusion
DE/H/2511/001 BE442181 FRESENIUS KABI NV/SA BE
Paracetamol Fresenius Kabi 10 mg/ml solution pour perfusion
DE/H/2511/001 BE442197 FRESENIUS KABI NV/SA BE
Paracetamol Generis 10 mg/ml Solução para perfusão
not available 5423520 GENERIS FARMACÊUTICA, S.A.
PT
Paracetamol Generis 10 mg/ml Solução para perfusão
not available 5423538 GENERIS FARMACÊUTICA, S.A.
PT
Paracetamol Grifols 10 mg/ml solução para perfusão
ES/H/0307/001 5658166 LABORATORIOS GRIFOLS, S.A.
PT
Paracetamol Grifols 10 mg/ml solução para perfusão
ES/H/0307/001 5658208 LABORATORIOS GRIFOLS, S.A.
PT
Paracetamol Grifols 10 mg/ml solução para perfusão
ES/H/0307/001 5658174 LABORATORIOS GRIFOLS, S.A.
PT
Paracetamol Grifols 10 mg/ml Solución para perfusión EFG
ES/H/0307/001 80117 LABORATORIOS GRIFOLS, S.A.
ES
Paracetamol Hexal 10 mg/ml Infusionslösung
DE/H/3248/001 84549.00.00 HEXAL AG DE
Paracetamol Hikma 10 mg/ml Infusionslösung
DE/H/3247/01/DC 84548.00.00 HIKMA PHARMA GMBH DE
Paracetamol Kabi 10 mg/ml Infusionslösung
DE/H/2511/001 1-30043 FRESENIUS KABI AUSTRIA GMBH
AT
Paracetamol Kabi 10 mg/ml Infusionslösung
DE/H/2511/001 78789.00.00 FRESENIUS KABI DEUTSCHLAND GMBH
DE
List of nationally authorised medicinal products EMA/819150/2016 Page 12/40
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Paracetamol Kabi 10 mg/ml Infusionslösung
DE/H/2511/001 0452/11010162 FRESENIUS KABI DEUTSCHLAND GMBH
LU
Paracetamol Kabi 10 mg/ml infuzinis tirpalas
DE/H/2511/001 LT/1/10/2268/002 FRESENIUS KABI POLSKA SP. Z O.O.
LT
Paracetamol Kabi 10 mg/ml infuzinis tirpalas
DE/H/2511/001 LT/1/10/2268/003 FRESENIUS KABI POLSKA SP. Z O.O.
LT
Paracetamol Kabi 10 mg/ml infuzinis tirpalas
DE/H/2511/001 LT/1/10/2268/004 FRESENIUS KABI POLSKA SP. Z O.O.
LT
Paracetamol Kabi 10 mg/ml infuzinis tirpalas
DE/H/2511/001 LT/1/10/2268/005 FRESENIUS KABI POLSKA SP. Z O.O.
LT
Paracetamol Kabi 10 mg/ml infuzinis tirpalas
DE/H/2511/001 LT/1/10/2268/006 FRESENIUS KABI POLSKA SP. Z O.O.
LT
Paracetamol Kabi 10 mg/ml infuzinis tirpalas
DE/H/2511/001 LT/1/10/2268/007 FRESENIUS KABI POLSKA SP. Z O.O.
LT
Paracetamol Kabi 10 mg/ml infuzinis tirpalas
DE/H/2511/001 LT/1/10/2268/008 FRESENIUS KABI POLSKA SP. Z O.O.
LT
Paracetamol Kabi 10 mg/ml infuzinis tirpalas
DE/H/2511/001 LT/1/10/2268/009 FRESENIUS KABI POLSKA SP. Z O.O.
LT
Paracetamol Kabi 10 mg/ml infuzinis tirpalas
DE/H/2511/001 LT/1/10/2268/010 FRESENIUS KABI POLSKA SP. Z O.O.
LT
Paracetamol Kabi 10 mg/ml infuzinis tirpalas
DE/H/2511/001 LT/1/10/2268/011 FRESENIUS KABI POLSKA SP. Z O.O.
LT
Paracetamol Kabi 10 mg/ml infuzinis tirpalas
DE/H/2511/001 LT/1/10/2268/012 FRESENIUS KABI POLSKA SP. Z O.O.
LT
Paracetamol Kabi 10 mg/ml infuzinis tirpalas
DE/H/2511/001 LT/1/10/2268/013 FRESENIUS KABI POLSKA SP. Z O.O.
LT
Paracetamol Kabi 10 mg/ml infuzinis tirpalas
DE/H/2511/001 LT/1/10/2268/014 FRESENIUS KABI POLSKA SP. Z O.O.
LT
Paracetamol Kabi 10 mg/ml infuzinis tirpalas
DE/H/2511/001 LT/1/10/2268/001 FRESENIUS KABI POLSKA SP. Z O.O.
LT
Paracetamol Kabi 10 mg/ml infúzny roztok
DE/H/2511/001 07/0728/10-S FRESENIUS KABI S.R.O SK
Paracetamol Kabi 10 mg/ml oldatos infúzió
DE/H/2511/001 OGYI-T-21800/02 FRESENIUS KABI HUNGARY KFT.
HU
Paracetamol Kabi 10 mg/ml oldatos infúzió
DE/H/2511/001 OGYI-T-21800/03 FRESENIUS KABI HUNGARY KFT.
HU
List of nationally authorised medicinal products EMA/819150/2016 Page 13/40
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Paracetamol Kabi 10 mg/ml oldatos infúzió
DE/H/2511/001 OGYI-T-21800/04 FRESENIUS KABI HUNGARY KFT.
HU
Paracetamol Kabi 10 mg/ml oldatos infúzió
DE/H/2511/001 OGYI-T-21800/05 FRESENIUS KABI HUNGARY KFT.
HU
Paracetamol Kabi 10 mg/ml oldatos infúzió
DE/H/2511/001 OGYI-T-21800/06 FRESENIUS KABI HUNGARY KFT.
HU
Paracetamol Kabi 10 mg/ml oldatos infúzió
DE/H/2511/001 OGYI-T-21800/07 FRESENIUS KABI HUNGARY KFT.
HU
Paracetamol Kabi 10 mg/ml oldatos infúzió
DE/H/2511/001 OGYI-T-21800/08 FRESENIUS KABI HUNGARY KFT.
HU
Paracetamol Kabi 10 mg/ml oldatos infúzió
DE/H/2511/001 OGYI-T-21800/09 FRESENIUS KABI HUNGARY KFT.
HU
Paracetamol Kabi 10 mg/ml oldatos infúzió
DE/H/2511/001 OGYI-T-21800/10 FRESENIUS KABI HUNGARY KFT.
HU
Paracetamol Kabi 10 mg/ml oldatos infúzió
DE/H/2511/001 OGYI-T-21800/11 FRESENIUS KABI HUNGARY KFT.
HU
Paracetamol Kabi 10 mg/ml oldatos infúzió
DE/H/2511/001 OGYI-T-21800/12 FRESENIUS KABI HUNGARY KFT.
HU
Paracetamol Kabi 10 mg/ml oldatos infúzió
DE/H/2511/001 OGYI-T-21800/13 FRESENIUS KABI HUNGARY KFT.
HU
Paracetamol Kabi 10 mg/ml oldatos infúzió
DE/H/2511/001 OGYI-T-21800/14 FRESENIUS KABI HUNGARY KFT.
HU
Paracetamol Kabi 10 mg/ml oldatos infúzió
DE/H/2511/001 OGYI-T-21800/01 FRESENIUS KABI HUNGARY KFT.
HU
Paracetamol Kabi 10 mg/ml otopina za infuziju
not available UP/I-530-09/12-01/271 FRESENIUS KABI D.O.O. HR
Paracetamol Kabi 10 mg/ml raztopina za infundiranje
DE/H/2511/001 H/11/01226/010 FRESENIUS KABI DEUTSCHLAND GMBH
SI
Paracetamol Kabi 10 mg/ml raztopina za infundiranje
DE/H/2511/001 H/11/01226/009 FRESENIUS KABI DEUTSCHLAND GMBH
SI
Paracetamol Kabi 10 mg/ml raztopina za infundiranje
DE/H/2511/001 H/11/01226/001 FRESENIUS KABI DEUTSCHLAND GMBH
SI
Paracetamol Kabi 10 mg/ml raztopina za infundiranje
DE/H/2511/001 H/11/01226/002 FRESENIUS KABI DEUTSCHLAND GMBH
SI
Paracetamol Kabi 10 mg/ml raztopina za infundiranje
DE/H/2511/001 H/11/01226/004 FRESENIUS KABI DEUTSCHLAND GMBH
SI
List of nationally authorised medicinal products EMA/819150/2016 Page 14/40
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Paracetamol Kabi 10 mg/ml raztopina za infundiranje
DE/H/2511/001 H/11/01226/003 FRESENIUS KABI DEUTSCHLAND GMBH
SI
Paracetamol Kabi 10 mg/ml raztopina za infundiranje
DE/H/2511/001 H/11/01226/005 FRESENIUS KABI DEUTSCHLAND GMBH
SI
Paracetamol Kabi 10 mg/ml raztopina za infundiranje
DE/H/2511/001 H/11/01226/006 FRESENIUS KABI DEUTSCHLAND GMBH
SI
Paracetamol Kabi 10 mg/ml raztopina za infundiranje
DE/H/2511/001 H/11/01226/007 FRESENIUS KABI DEUTSCHLAND GMBH
SI
Paracetamol Kabi 10 mg/ml raztopina za infundiranje
DE/H/2511/001 H/11/01226/008 FRESENIUS KABI DEUTSCHLAND GMBH
SI
Paracetamol Kabi 10 mg/ml raztopina za infundiranje
DE/H/2511/001 H/11/01226/013 FRESENIUS KABI DEUTSCHLAND GMBH
SI
Paracetamol Kabi 10 mg/ml raztopina za infundiranje
DE/H/2511/001 H/11/01226/014 FRESENIUS KABI DEUTSCHLAND GMBH
SI
Paracetamol Kabi 10 mg/ml raztopina za infundiranje
DE/H/2511/001 H/11/01226/011 FRESENIUS KABI DEUTSCHLAND GMBH
SI
Paracetamol Kabi 10 mg/ml raztopina za infundiranje
DE/H/2511/001 H/11/01226/012 FRESENIUS KABI DEUTSCHLAND GMBH
SI
Paracetamol Kabi 10 mg/ml šķīdums infūzijām
DE/H/2511/001 10-0611 FRESENIUS KABI POLSKA SP. Z O.O.
LV
Paracetamol Kabi 10 mg/mL solução para perfusão
DE/H/2511/001 5584305 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
Paracetamol Kabi 10 mg/mL solução para perfusão
DE/H/2511/001 5584321 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
Paracetamol Kabi 10 mg/mL solução para perfusão
DE/H/2511/001 5584313 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
Paracetamol Kabi 10 mg/mL solução para perfusão
DE/H/2511/001 5584271 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
Paracetamol Kabi 10 mg/mL solução para perfusão
DE/H/2511/001 5584263 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
Paracetamol Kabi 10 mg/mL solução para perfusão
DE/H/2511/001 5584255 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
Paracetamol Kabi 10 mg/mL solução para perfusão
DE/H/2511/001 5338736 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
Paracetamol Kabi 10 mg/mL solução para perfusão
DE/H/2511/001 5338728 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
List of nationally authorised medicinal products EMA/819150/2016 Page 15/40
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Paracetamol Kabi 10 mg/mL solução para perfusão
DE/H/2511/001 5338710 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
Paracetamol Kabi 10 mg/mL solução para perfusão
DE/H/2511/001 5338702 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
Paracetamol Kabi 10 mg/mL solução para perfusão
DE/H/2511/001 5338660 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
Paracetamol Kabi 10 mg/mL solução para perfusão
DE/H/2511/001 5338652 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
Paracetamol Kabi 10 mg/mL solução para perfusão
DE/H/2511/001 5338678 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
Paracetamol Kabi 10 mg/mL solução para perfusão
DE/H/2511/001 5338645 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
Paracetamol Kabi 10 mg/ml solución para perfusión EFG
DE/H/2511/001 74.477 FRESENIUS KABI ESPAÑA S.A.U.
ES
Paracetamol Kabi 10 mg/ml soluţie perfuzabilă
DE/H/2511/001 8237/2015/10 FRESENIUS KABI ROMANIA S.R.L.
RO
Paracetamol Kabi 10 mg/ml soluţie perfuzabilă
DE/H/2511/001 8237/2015/11 FRESENIUS KABI ROMANIA S.R.L.
RO
Paracetamol Kabi 10 mg/ml soluţie perfuzabilă
DE/H/2511/001 8237/2015/09 FRESENIUS KABI ROMANIA S.R.L.
RO
Paracetamol Kabi 10 mg/ml soluţie perfuzabilă
DE/H/2511/001 8237/2015/13 FRESENIUS KABI ROMANIA S.R.L.
RO
Paracetamol Kabi 10 mg/ml soluţie perfuzabilă
DE/H/2511/001 8237/2015/14 FRESENIUS KABI ROMANIA S.R.L.
RO
Paracetamol Kabi 10 mg/ml soluţie perfuzabilă
DE/H/2511/001 8237/2015/12 FRESENIUS KABI ROMANIA S.R.L.
RO
Paracetamol Kabi 10 mg/ml soluţie perfuzabilă
DE/H/2511/001 8237/2015/01 FRESENIUS KABI ROMANIA S.R.L.
RO
Paracetamol Kabi 10 mg/ml soluţie perfuzabilă
DE/H/2511/001 8237/2015/02 FRESENIUS KABI ROMANIA S.R.L.
RO
Paracetamol Kabi 10 mg/ml soluţie perfuzabilă
DE/H/2511/001 8237/2015/03 FRESENIUS KABI ROMANIA S.R.L.
RO
Paracetamol Kabi 10 mg/ml soluţie perfuzabilă
DE/H/2511/001 8237/2015/04 FRESENIUS KABI ROMANIA S.R.L.
RO
Paracetamol Kabi 10 mg/ml soluţie perfuzabilă
DE/H/2511/001 8237/2015/05 FRESENIUS KABI ROMANIA S.R.L.
RO
List of nationally authorised medicinal products EMA/819150/2016 Page 16/40
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Paracetamol Kabi 10 mg/ml soluţie perfuzabilă
DE/H/2511/001 8237/2015/06 FRESENIUS KABI ROMANIA S.R.L.
RO
Paracetamol Kabi 10 mg/ml soluţie perfuzabilă
DE/H/2511/001 8237/2015/07 FRESENIUS KABI ROMANIA S.R.L.
RO
Paracetamol Kabi 10 mg/ml soluţie perfuzabilă
DE/H/2511/001 8237/2015/08 FRESENIUS KABI ROMANIA S.R.L.
RO
Paracetamol Kabi 10 mg/ml, infusioonilahus
DE/H/2511/001 715010 FRESENIUS KABI POLSKA SP. Z O.O.
EE
Paracetamol Kabi 10 mg/ml, infuzní roztok
DE/H/2511/001 07/967/10-C FRESENIUS KABI S.R.O CZ
PARACETAMOL KABI 10 mg/ml, solution pour perfusion
not available 34009 582 494 1 9 FRESENIUS KABI FRANCE S.A.S.
FR
PARACETAMOL KABI 10 mg/ml, solution pour perfusion
not available 34009 582 492 9 7 FRESENIUS KABI FRANCE S.A.S.
FR
PARACETAMOL KABI 10 mg/ml, solution pour perfusion
not available 34009 580 073 9 2 FRESENIUS KABI FRANCE S.A.S.
FR
PARACETAMOL KABI 10 mg/ml, solution pour perfusion
not available 34009 580 074 5 3 FRESENIUS KABI FRANCE S.A.S.
FR
PARACETAMOL KABI 10 mg/ml, solution pour perfusion
not available 34009 580 075 1 4 FRESENIUS KABI FRANCE S.A.S.
FR
PARACETAMOL KABI 10 mg/ml, solution pour perfusion
not available 34009 580 076 8 2 FRESENIUS KABI FRANCE S.A.S.
FR
PARACETAMOL KABI 10 mg/ml, solution pour perfusion
not available 34009 580 077 4 3 FRESENIUS KABI FRANCE S.A.S.
FR
PARACETAMOL KABI 10 mg/ml, solution pour perfusion
not available 34009 580 078 0 4 FRESENIUS KABI FRANCE S.A.S.
FR
List of nationally authorised medicinal products EMA/819150/2016 Page 17/40
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
PARACETAMOL KABI 10 mg/ml, solution pour perfusion
not available 34009 580 079 7 2 FRESENIUS KABI FRANCE S.A.S.
FR
PARACETAMOL KABI 10 mg/ml, solution pour perfusion
not available 34009 580 080 5 4 FRESENIUS KABI FRANCE S.A.S.
FR
PARACETAMOL KABI 10 mg/ml, solution pour perfusion
not available 34009 582 493 5 8 FRESENIUS KABI FRANCE S.A.S.
FR
Paracetamol Kabi, 10 mg/ml, roztwór do infuzji
DE/H/2511/001 18152 FRESENIUS KABI POLSKA SP. Z O.O.
PL
Paracetamol Kern Pharma 10 mg/ml solución para perfusión EFG
PT/H/1003/001 78.690 KERN PHARMA, S.L. ES
PARACETAMOL MACOPHARMA 10 mg/ml Infusionslösung
FR/H/0472/001 BE 458773 MACO PHARMA BENELUX BE
PARACETAMOL MACOPHARMA 10 mg/ml Infusionslösung
FR/H/0472/001 BE 393994 MACO PHARMA BENELUX BE
PARACETAMOL MACOPHARMA 10 mg/ml Infusionslösung
FR/H/0472/001 BE 394021 MACO PHARMA BENELUX BE
PARACETAMOL MACOPHARMA 10 mg/ml Infusionslösung
FR/H/0472/001 BE 394003 MACO PHARMA BENELUX BE
PARACETAMOL MACOPHARMA 10 mg/ml Infusionslösung
FR/H/0472/001 BE 394012 MACO PHARMA BENELUX BE
PARACETAMOL MACOPHARMA 10 mg/ml Infusionslösung
FR/H/0472/001 82489.00.00 MACO PHARMA INTERNATIONAL GMBH
DE
PARACETAMOL MACOPHARMA 10 mg/ml, oplossing voor infusie
FR/H/0472/001 BE 458773 MACO PHARMA BENELUX BE
List of nationally authorised medicinal products EMA/819150/2016 Page 18/40
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
PARACETAMOL MACOPHARMA 10 mg/ml, oplossing voor infusie
FR/H/0472/001 BE 393994 MACO PHARMA BENELUX BE
PARACETAMOL MACOPHARMA 10 mg/ml, oplossing voor infusie
FR/H/0472/001 BE 394012 MACO PHARMA BENELUX BE
PARACETAMOL MACOPHARMA 10 mg/ml, oplossing voor infusie
FR/H/0472/001 BE 394003 MACO PHARMA BENELUX BE
PARACETAMOL MACOPHARMA 10 mg/ml, oplossing voor infusie
FR/H/0472/001 BE 394021 MACO PHARMA BENELUX BE
PARACETAMOL MACOPHARMA 10 mg/ml, solution pour perfusion
FR/H/0472/001 BE 458773 MACO PHARMA BENELUX BE
PARACETAMOL MACOPHARMA 10 mg/ml, solution pour perfusion
FR/H/0472/001 BE 393994 MACO PHARMA BENELUX BE
PARACETAMOL MACOPHARMA 10 mg/ml, solution pour perfusion
FR/H/0472/001 BE 394003 MACO PHARMA BENELUX BE
PARACETAMOL MACOPHARMA 10 mg/ml, solution pour perfusion
FR/H/0472/001 BE 394021 MACO PHARMA BENELUX BE
PARACETAMOL MACOPHARMA 10 mg/ml, solution pour perfusion
FR/H/0472/001 BE 394012 MACO PHARMA BENELUX BE
PARACETAMOL MACOPHARMA 10 mg/ml, solution pour perfusion
FR/H/0472/001 34009 586 688 5 2 MACO PHARMA FR
PARACETAMOL MACOPHARMA 10 mg/ml, solution pour perfusion
FR/H/0472/001 34009 586 685 6 2 MACO PHARMA FR
PARACETAMOL MACOPHARMA 10 mg/ml, solution pour perfusion
FR/H/0472/001 34009 586 686 2 3 MACO PHARMA FR
List of nationally authorised medicinal products EMA/819150/2016 Page 19/40
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
PARACETAMOL MACOPHARMA 10 mg/ml, solution pour perfusion
FR/H/0472/001 34009 586 687 9 1 MACO PHARMA FR
PARACETAMOL MACOPHARMA 10 mg/ml, solution pour perfusion
FR/H/0472/001 34009 586 689 1 3 MACO PHARMA FR
PARACETAMOL MACOPHARMA 10 mg/ml, solution pour perfusion
FR/H/0472/001 34009 576 882 3 3 MACO PHARMA FR
PARACETAMOL MACOPHARMA 10 mg/ml, solution pour perfusion
FR/H/0472/001 34009 576 890 6 3 MACO PHARMA FR
PARACETAMOL MACOPHARMA 10 mg/ml, solution pour perfusion
FR/H/0472/001 34009 576 888 1 3 MACO PHARMA FR
PARACETAMOL MACOPHARMA 10 mg/ml, solution pour perfusion
FR/H/0472/001 34009 576 884 6 2 MACO PHARMA FR
PARACETAMOL MACOPHARMA 10 mg/ml, solution pour perfusion
FR/H/0472/001 34009 576 885 2 3 MACO PHARMA FR
PARACETAMOL MACOPHARMA 10 mg/ml, solution pour perfusion
FR/H/0472/001 34009 576 886 9 1 MACO PHARMA FR
PARACETAMOL MACOPHARMA 10 mg/ml, solution pour perfusion
FR/H/0472/001 34009 576 887 5 2 MACO PHARMA FR
PARACETAMOL MACOPHARMA 10 mg/ml, solution pour perfusion
FR/H/0472/001 34009 576 889 8 1 MACO PHARMA FR
PARACETAMOL MACOPHARMA 10 mg/ml, solution pour perfusion
FR/H/0472/001 34009 576 891 2 4 MACO PHARMA FR
PARACETAMOL MACOPHARMA 10 mg/ml, solution pour perfusion
FR/H/0472/001 34009 576 892 9 2 MACO PHARMA FR
List of nationally authorised medicinal products EMA/819150/2016 Page 20/40
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
PARACETAMOL MACOPHARMA 10 mg/ml, solution pour perfusion
FR/H/0472/001 34009 576 893 5 3 MACO PHARMA FR
PARACETAMOL MACOPHARMA 10 mg/ml, solution pour perfusion
FR/H/0472/001 34009 576 894 1 4 MACO PHARMA FR
PARACETAMOL MACOPHARMA 10 mg/ml, solution pour perfusion
FR/H/0472/001 34009 576 895 8 2 MACO PHARMA FR
PARACETAMOL MACOPHARMA 10 mg/ml, solution pour perfusion
FR/H/0472/001 34009 576 896 4 3 MACO PHARMA FR
PARACETAMOL MACOPHARMA 10 mg/ml, solution pour perfusion
FR/H/0472/001 34009 576 897 0 4 MACO PHARMA FR
PARACETAMOL MACOPHARMA 10 mg/ml, solution pour perfusion
FR/H/0472/001 34009 576 898 7 2 MACO PHARMA FR
PARACETAMOL MACOPHARMA 10 mg/ml, solution pour perfusion
FR/H/0472/001 34009 576 899 3 3 MACO PHARMA FR
PARACETAMOL MACOPHARMA 10 mg/ml, solution pour perfusion
FR/H/0472/001 34009 576 900 1 4 MACO PHARMA FR
PARACETAMOL MACOPHARMA 10 mg/ml, solution pour perfusion
FR/H/0472/001 34009 576 901 8 2 MACO PHARMA FR
PARACETAMOL MACOPHARMA 10 mg/ml, solution pour perfusion
FR/H/0472/001 34009 576 902 4 3 MACO PHARMA FR
PARACETAMOL MACOPHARMA 10 mg/ml, solution pour perfusion
FR/H/0472/001 34009 576 903 0 4 MACO PHARMA FR
PARACETAMOL MACOPHARMA 10 mg/ml, solution pour perfusion
FR/H/0472/001 34009 576 904 7 2 MACO PHARMA FR
List of nationally authorised medicinal products EMA/819150/2016 Page 21/40
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
PARACETAMOL MACOPHARMA 10 mg/ml, solution pour perfusion
FR/H/0472/001 34009 576 905 3 3 MACO PHARMA FR
PARACETAMOL MACOPHARMA 10 mg/ml, solution pour perfusion
FR/H/0472/001 34009 576 907 6 2 MACO PHARMA FR
PARACETAMOL MACOPHARMA 10 mg/ml, solution pour perfusion
FR/H/0472/001 34009 576 908 2 3 MACO PHARMA FR
PARACETAMOL MACOPHARMA 10 mg/ml, solution pour perfusion
FR/H/0472/001 34009 576 909 9 1 MACO PHARMA FR
PARACETAMOL MACOPHARMA 10 mg/ml, solution pour perfusion
FR/H/0472/001 34009 576 910 7 3 MACO PHARMA FR
PARACETAMOL MACOPHARMA 10 mg/ml, solution pour perfusion
FR/H/0472/001 34009 576 911 3 4 MACO PHARMA FR
PARACETAMOL MACOPHARMA 10 mg/ml, solution pour perfusion
FR/H/0472/001 1211/11030030 MACO PHARMA LU
Paracetamol Noridem 10 mg / ml Solução para perfusão
PT/H/1003/001 5607510 NORIDEM ENTERPRISES LTD PT
Paracetamol Noridem 10 mg / ml Solução para perfusão
PT/H/1003/001 5607452 NORIDEM ENTERPRISES LTD PT
Paracetamol Noridem 10 mg / ml Solução para perfusão
PT/H/1003/001 5607460 NORIDEM ENTERPRISES LTD PT
Paracetamol Noridem 10 mg / ml Solução para perfusão
PT/H/1003/001 5607502 NORIDEM ENTERPRISES LTD PT
Paracetamol Noridem 10 mg / ml Solução para perfusão
PT/H/1003/001 5607478 NORIDEM ENTERPRISES LTD PT
Paracetamol Noridem 10 mg / ml Solução para perfusão
PT/H/1003/001 5607528 NORIDEM ENTERPRISES LTD PT
Paracetamol Noridem 10 mg / ml Solução para perfusão
PT/H/1003/001 5607536 NORIDEM ENTERPRISES LTD PT
List of nationally authorised medicinal products EMA/819150/2016 Page 22/40
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Paracetamol Noridem 10 mg / ml Solução para perfusão
PT/H/1003/001 5607544 NORIDEM ENTERPRISES LTD PT
Paracetamol Noridem 10 mg/ml Infusionslösung
PT/H/1003/001 89627.00.00 NORIDEM ENTERPRISES LTD DE
Paracetamol NORMON 10 mg/ml solución para perfusión EFG
not available 71530 LABORATORIOS NORMON, S.A.
ES
Paracetamol Panpharma 10 mg/ml infusionsvätska, lösning
FR/H/0355/001 26934 PANMEDICA SE
Paracetamol Panpharma 10 mg/ml infusionsvätska, lösning
FR/H/0355/001 26934 PANMEDICA SE
Paracetamol Panpharma 10 mg/ml infusionsvätska, lösning
FR/H/0355/001 26934 PANMEDICA SE
Paracetamol Panpharma 10 mg/ml infusionsvätska, lösning
FR/H/0355/001 26934 PANMEDICA SE
Paracetamol Panpharma 10 mg/ml infusionsvätska, lösning
FR/H/0355/001 26934 PANMEDICA SE
Paracetamol Panpharma 10 mg/ml infusionsvätska, lösning
FR/H/0355/001 26934 PANMEDICA SE
Paracetamol Panpharma 10 mg/ml infusionsvätska, lösning
FR/H/0355/001 26934 PANMEDICA SE
Paracetamol Panpharma 10 mg/ml infusionsvätska, lösning
FR/H/0355/001 26934 PANMEDICA SE
Paracetamol Panpharma 10 mg/ml infusionsvätska, lösning
FR/H/0355/001 26934 PANMEDICA SE
List of nationally authorised medicinal products EMA/819150/2016 Page 23/40
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Paracetamol Panpharma 10 mg/ml infusionsvätska, lösning
FR/H/0355/001 26934 PANMEDICA SE
Paracetamol Panpharma 10 mg/ml infusionsvätska, lösning
FR/H/0355/001 26934 PANMEDICA SE
Paracetamol Panpharma 10 mg/ml infusionsvätska, lösning
FR/H/0355/001 26934 PANMEDICA SE
Paracetamol Panpharma 10 mg/ml infusionsvätska, lösning
FR/H/0355/001 26934 PANMEDICA SE
Paracetamol Panpharma 10 mg/ml infusionsvätska, lösning
FR/H/0355/001 26934 PANMEDICA SE
Paracetamol Panpharma 10 mg/ml infusionsvätska, lösning
FR/H/0355/001 26934 PANMEDICA SE
Paracetamol Panpharma 10 mg/ml infuusioneste, liuos
FR/H/0355/001 28579 PANMEDICA FI
Paracetamol Panpharma 10 mg/ml infuusioneste, liuos
FR/H/0355/001 28579 PANMEDICA FI
Paracetamol Panpharma 10 mg/ml infuusioneste, liuos
FR/H/0355/001 28579 PANMEDICA FI
Paracetamol Panpharma 10 mg/ml infuusioneste, liuos
FR/H/0355/001 28579 PANMEDICA FI
Paracetamol Panpharma 10 mg/ml infuusioneste, liuos
FR/H/0355/001 28579 PANMEDICA FI
Paracetamol Panpharma 10 mg/ml infuusioneste, liuos
FR/H/0355/001 28579 PANMEDICA FI
Paracetamol Panpharma 10 mg/ml infuusioneste, liuos
FR/H/0355/001 28579 PANMEDICA FI
Paracetamol Panpharma 10 mg/ml infuusioneste, liuos
FR/H/0355/001 28579 PANMEDICA FI
Paracetamol Panpharma 10 mg/ml infuusioneste, liuos
FR/H/0355/001 28579 PANMEDICA FI
List of nationally authorised medicinal products EMA/819150/2016 Page 24/40
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Paracetamol Panpharma 10 mg/ml infuusioneste, liuos
FR/H/0355/001 28579 PANMEDICA FI
Paracetamol Panpharma 10 mg/ml infuusioneste, liuos
FR/H/0355/001 28579 PANMEDICA FI
Paracetamol Panpharma 10 mg/ml infuusioneste, liuos
FR/H/0355/001 28579 PANMEDICA FI
Paracetamol Panpharma 10 mg/ml infuusioneste, liuos
FR/H/0355/001 28579 PANMEDICA FI
Paracetamol Panpharma 10 mg/ml infuusioneste, liuos
FR/H/0355/001 28579 PANMEDICA FI
Paracetamol Panpharma 10 mg/ml infuusioneste, liuos
FR/H/0355/001 28579 PANMEDICA FI
Paracetamol Panpharma 10 mg/ml infuzinis tirpalas
FR/H/0355/001 LT/1/10/2343/001 PANMEDICA LT
Paracetamol Panpharma 10 mg/ml infuzinis tirpalas
FR/H/0355/001 LT/1/10/2343/002 PANMEDICA LT
Paracetamol Panpharma 10 mg/ml infuzinis tirpalas
FR/H/0355/001 LT/1/10/2343/003 PANMEDICA LT
Paracetamol Panpharma 10 mg/ml infuzinis tirpalas
FR/H/0355/001 LT/1/10/2343/004 PANMEDICA LT
Paracetamol Panpharma 10 mg/ml infuzinis tirpalas
FR/H/0355/001 LT/1/10/2343/005 PANMEDICA LT
Paracetamol Panpharma 10 mg/ml infuzinis tirpalas
FR/H/0355/001 LT/1/10/2343/006 PANMEDICA LT
Paracetamol Panpharma 10 mg/ml infuzinis tirpalas
FR/H/0355/001 LT/1/10/2343/007 PANMEDICA LT
Paracetamol Panpharma 10 mg/ml infuzinis tirpalas
FR/H/0355/001 LT/1/10/2343/008 PANMEDICA LT
Paracetamol Panpharma 10 mg/ml infuzinis tirpalas
FR/H/0355/001 LT/1/10/2343/009 PANMEDICA LT
Paracetamol Panpharma 10 mg/ml infuzinis tirpalas
FR/H/0355/001 LT/1/10/2343/010 PANMEDICA LT
Paracetamol Panpharma 10 mg/ml infuzinis tirpalas
FR/H/0355/001 LT/1/10/2343/011 PANMEDICA LT
Paracetamol Panpharma 10 mg/ml infuzinis tirpalas
FR/H/0355/001 LT/1/10/2343/012 PANMEDICA LT
List of nationally authorised medicinal products EMA/819150/2016 Page 25/40
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
PARACETAMOL PANPHARMA 10 mg/ml oldatos infúzió
FR/H/0355/001 OGYI-T-21749/01 PANMEDICA HU
PARACETAMOL PANPHARMA 10 mg/ml oldatos infúzió
FR/H/0355/001 OGYI-T-21749/02 PANMEDICA HU
PARACETAMOL PANPHARMA 10 mg/ml oldatos infúzió
FR/H/0355/001 OGYI-T-21749/03 PANMEDICA HU
PARACETAMOL PANPHARMA 10 mg/ml oldatos infúzió
FR/H/0355/001 OGYI-T-21749/04 PANMEDICA HU
PARACETAMOL PANPHARMA 10 mg/ml oldatos infúzió
FR/H/0355/001 OGYI-T-21749/05 PANMEDICA HU
PARACETAMOL PANPHARMA 10 mg/ml oldatos infúzió
FR/H/0355/001 OGYI-T-21749/06 PANMEDICA HU
PARACETAMOL PANPHARMA 10 mg/ml oldatos infúzió
FR/H/0355/001 OGYI-T-21749/07 PANMEDICA HU
PARACETAMOL PANPHARMA 10 mg/ml oldatos infúzió
FR/H/0355/001 OGYI-T-21749/08 PANMEDICA HU
PARACETAMOL PANPHARMA 10 mg/ml oldatos infúzió
FR/H/0355/001 OGYI-T-21749/09 PANMEDICA HU
PARACETAMOL PANPHARMA 10 mg/ml oldatos infúzió
FR/H/0355/001 OGYI-T-21749/10 PANMEDICA HU
PARACETAMOL PANPHARMA 10 mg/ml oldatos infúzió
FR/H/0355/001 OGYI-T-21749/11 PANMEDICA HU
PARACETAMOL PANPHARMA 10 mg/ml oldatos infúzió
FR/H/0355/001 OGYI-T-21749/12 PANMEDICA HU
PARACETAMOL PANPHARMA 10 mg/ml oldatos infúzió
FR/H/0355/001 OGYI-T-21749/13 PANMEDICA HU
PARACETAMOL PANPHARMA 10 mg/ml oldatos infúzió
FR/H/0355/001 OGYI-T-21749/14 PANMEDICA HU
PARACETAMOL PANPHARMA 10 mg/ml oldatos infúzió
FR/H/0355/001 OGYI-T-21749/15 PANMEDICA HU
PARACETAMOL PANPHARMA 10 mg/ml šķīdums infūzijām
FR/H/0355/001 10-0627 PANMEDICA LV
PARACETAMOL PANPHARMA 10 mg/ml šķīdums infūzijām
FR/H/0355/001 10-0627 PANMEDICA LV
PARACETAMOL PANPHARMA 10 mg/ml šķīdums infūzijām
FR/H/0355/001 10-0627 PANMEDICA LV
List of nationally authorised medicinal products EMA/819150/2016 Page 26/40
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
PARACETAMOL PANPHARMA 10 mg/ml šķīdums infūzijām
FR/H/0355/001 10-0627 PANMEDICA LV
PARACETAMOL PANPHARMA 10 mg/ml šķīdums infūzijām
FR/H/0355/001 10-0627 PANMEDICA LV
PARACETAMOL PANPHARMA 10 mg/ml šķīdums infūzijām
FR/H/0355/001 10-0627 PANMEDICA LV
PARACETAMOL PANPHARMA 10 mg/ml šķīdums infūzijām
FR/H/0355/001 10-0627 PANMEDICA LV
PARACETAMOL PANPHARMA 10 mg/ml šķīdums infūzijām
FR/H/0355/001 10-0627 PANMEDICA LV
PARACETAMOL PANPHARMA 10 mg/ml šķīdums infūzijām
FR/H/0355/001 10-0627 PANMEDICA LV
PARACETAMOL PANPHARMA 10 mg/ml šķīdums infūzijām
FR/H/0355/001 10-0627 PANMEDICA LV
PARACETAMOL PANPHARMA 10 mg/ml šķīdums infūzijām
FR/H/0355/001 10-0627 PANMEDICA LV
PARACETAMOL PANPHARMA 10 mg/ml šķīdums infūzijām
FR/H/0355/001 10-0627 PANMEDICA LV
PARACETAMOL PANPHARMA 10 mg/ml šķīdums infūzijām
FR/H/0355/001 10-0627 PANMEDICA LV
PARACETAMOL PANPHARMA 10 mg/ml šķīdums infūzijām
FR/H/0355/001 10-0627 PANMEDICA LV
PARACETAMOL PANPHARMA 10 mg/ml šķīdums infūzijām
FR/H/0355/001 10-0627 PANMEDICA LV
Paracetamol Panpharma 10 mg/ml, infusjonsvæske, oppløsning
FR/H/0355/001 08-5909 PANMEDICA NO
Paracetamol Panpharma 10 mg/ml, infusjonsvæske, oppløsning
FR/H/0355/001 08-5909 PANMEDICA NO
Paracetamol Panpharma 10 mg/ml, infusjonsvæske, oppløsning
FR/H/0355/001 08-5909 PANMEDICA NO
Paracetamol Panpharma 10 mg/ml, infusjonsvæske, oppløsning
FR/H/0355/001 08-5909 PANMEDICA NO
List of nationally authorised medicinal products EMA/819150/2016 Page 27/40
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Paracetamol Panpharma 10 mg/ml, infusjonsvæske, oppløsning
FR/H/0355/001 08-5909 PANMEDICA NO
Paracetamol Panpharma 10 mg/ml, infusjonsvæske, oppløsning
FR/H/0355/001 08-5909 PANMEDICA NO
Paracetamol Panpharma 10 mg/ml, infusjonsvæske, oppløsning
FR/H/0355/001 08-5909 PANMEDICA NO
Paracetamol Panpharma 10 mg/ml, infusjonsvæske, oppløsning
FR/H/0355/001 08-5909 PANMEDICA NO
Paracetamol Panpharma 10 mg/ml, infusjonsvæske, oppløsning
FR/H/0355/001 08-5909 PANMEDICA NO
Paracetamol Panpharma 10 mg/ml, infusjonsvæske, oppløsning
FR/H/0355/001 08-5909 PANMEDICA NO
Paracetamol Panpharma 10 mg/ml, infusjonsvæske, oppløsning
FR/H/0355/001 08-5909 PANMEDICA NO
Paracetamol Panpharma 10 mg/ml, infusjonsvæske, oppløsning
FR/H/0355/001 08-5909 PANMEDICA NO
Paracetamol Panpharma 10 mg/ml, infusjonsvæske, oppløsning
FR/H/0355/001 08-5909 PANMEDICA NO
Paracetamol Panpharma 10 mg/ml, infusjonsvæske, oppløsning
FR/H/0355/001 08-5909 PANMEDICA NO
Paracetamol Panpharma 10 mg/ml, infusjonsvæske, oppløsning
FR/H/0355/001 08-5909 PANMEDICA NO
Paracetamol Panpharma 10 mg/ml, soluţie perfuzabilă
FR/H/0355/001 3337/2011/01 PANMEDICA RO
List of nationally authorised medicinal products EMA/819150/2016 Page 28/40
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Paracetamol Panpharma 10 mg/ml, soluţie perfuzabilă
FR/H/0355/001 3337/2011/02 PANMEDICA RO
Paracetamol Panpharma 10 mg/ml, soluţie perfuzabilă
FR/H/0355/001 3337/2011/03 PANMEDICA RO
Paracetamol Panpharma 10 mg/ml, soluţie perfuzabilă
FR/H/0355/001 3337/2011/04 PANMEDICA RO
Paracetamol Panpharma 10 mg/ml, soluţie perfuzabilă
FR/H/0355/001 3337/2011/05 PANMEDICA RO
Paracetamol Panpharma 10 mg/ml, soluţie perfuzabilă
FR/H/0355/001 3337/2011/06 PANMEDICA RO
PARACETAMOL PANPHARMA 10 mg/ml, solution pour perfusion
FR/H/0355/001 34009 585 640 9 3 PANMEDICA FR
PARACETAMOL PANPHARMA 10 mg/ml, solution pour perfusion
FR/H/0355/001 34009 585 641 5 4 PANMEDICA FR
PARACETAMOL PANPHARMA 10 mg/ml, solution pour perfusion
FR/H/0355/001 34009 585 642 1 5 PANMEDICA FR
PARACETAMOL PANPHARMA 10 mg/ml, solution pour perfusion
FR/H/0355/001 34009 585 643 8 3 PANMEDICA FR
PARACETAMOL PANPHARMA 10 mg/ml, solution pour perfusion
FR/H/0355/001 34009 585 644 4 4 PANMEDICA FR
PARACETAMOL PANPHARMA 10 mg/ml, solution pour perfusion
FR/H/0355/001 34009 585 645 0 5 PANMEDICA FR
PARACETAMOL PANPHARMA 10 mg/ml, solution pour perfusion
FR/H/0355/001 34009 585 646 7 3 PANMEDICA FR
PARACETAMOL PANPHARMA 10 mg/ml, solution pour perfusion
FR/H/0355/001 34009 585 647 3 4 PANMEDICA FR
List of nationally authorised medicinal products EMA/819150/2016 Page 29/40
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
PARACETAMOL PANPHARMA 10 mg/ml, solution pour perfusion
FR/H/0355/001 34009 585 649 6 3 PANMEDICA FR
PARACETAMOL PANPHARMA 10 mg/ml, solution pour perfusion
FR/H/0355/001 34009 571 860 1 2 PANMEDICA FR
PARACETAMOL PANPHARMA 10 mg/ml, solution pour perfusion
FR/H/0355/001 34009 571 861 8 0 PANMEDICA FR
PARACETAMOL PANPHARMA 10 mg/ml, solution pour perfusion
FR/H/0355/001 34009 571 862 4 1 PANMEDICA FR
PARACETAMOL PANPHARMA 10 mg/ml, solution pour perfusion
FR/H/0355/001 34009 571 863 0 2 PANMEDICA FR
PARACETAMOL PANPHARMA 10 mg/ml, solution pour perfusion
FR/H/0355/001 34009 572 996 4 4 PANMEDICA FR
PARACETAMOL PANPHARMA 10 mg/ml, solution pour perfusion
FR/H/0355/001 34009 572 997 0 5 PANMEDICA FR
Paracetamol Panpharma, 10 mg/mL, roztwór do infuzji
FR/H/0355/001 18132 PANMEDICA PL
Paracetamol Panpharma, 10 mg/mL, roztwór do infuzji
FR/H/0355/001 18132 PANMEDICA PL
Paracetamol Panpharma, 10 mg/mL, roztwór do infuzji
FR/H/0355/001 18132 PANMEDICA PL
Paracetamol Panpharma, 10 mg/mL, roztwór do infuzji
FR/H/0355/001 18132 PANMEDICA PL
Paracetamol Panpharma, 10 mg/mL, roztwór do infuzji
FR/H/0355/001 18132 PANMEDICA PL
Paracetamol Panpharma, 10 mg/mL, roztwór do infuzji
FR/H/0355/001 18132 PANMEDICA PL
Paracetamol Panpharma, 10 mg/mL, roztwór do infuzji
FR/H/0355/001 18132 PANMEDICA PL
List of nationally authorised medicinal products EMA/819150/2016 Page 30/40
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Paracetamol Panpharma, 10 mg/mL, roztwór do infuzji
FR/H/0355/001 18132 PANMEDICA PL
Paracetamol Panpharma, 10 mg/mL, roztwór do infuzji
FR/H/0355/001 18132 PANMEDICA PL
Paracetamol Panpharma, 10 mg/mL, roztwór do infuzji
FR/H/0355/001 18132 PANMEDICA PL
Paracetamol Panpharma, 10 mg/mL, roztwór do infuzji
FR/H/0355/001 18132 PANMEDICA PL
Paracetamol Panpharma, 10 mg/mL, roztwór do infuzji
FR/H/0355/001 18132 PANMEDICA PL
Paracetamol Pentafarma 10 mg/ml solução para perfusão
PT/H/0554/001 5455142 PENTAFARMA - SOCIEDADE TECNICO-MEDICINAL S.A.
PT
Paracetamol Pentafarma 10 mg/ml solução para perfusão
PT/H/0554/001 5455159 PENTAFARMA - SOCIEDADE TECNICO-MEDICINAL S.A.
PT
Paracetamol Pentafarma 10 mg/ml solução para perfusão
PT/H/0554/001 5455167 PENTAFARMA - SOCIEDADE TECNICO-MEDICINAL S.A.
PT
Paracetamol Pentafarma 10 mg/ml solução para perfusão
PT/H/0554/001 5461629 PENTAFARMA - SOCIEDADE TECNICO-MEDICINAL S.A.
PT
Paracetamol Polpharma, 10 mg/ml, roztwór do infuzji
DE/H/3247/001 20959 ZAKLADY FARMACEUTYCZNE "POLPHARMA" SPOLKA AKCYJNA
PL
Paracetamol Polpharma, 10 mg/ml, roztwór do infuzji
DE/H/3247/001 20959 ZAKLADY FARMACEUTYCZNE "POLPHARMA" SPOLKA AKCYJNA
PL
PARACETAMOL ROTEXMEDICA 10 mg/ml Infusionslösung
FR/H/0355/001 73831.00.00 PANMEDICA DE
PARACETAMOL ROTEXMEDICA 10 mg/ml Infusionslösung
FR/H/0355/001 73831.00.00 PANMEDICA DE
List of nationally authorised medicinal products EMA/819150/2016 Page 31/40
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
PARACETAMOL ROTEXMEDICA 10 mg/ml Infusionslösung
FR/H/0355/001 73831.00.00 PANMEDICA DE
PARACETAMOL ROTEXMEDICA 10 mg/ml Infusionslösung
FR/H/0355/001 73831.00.00 PANMEDICA DE
PARACETAMOL ROTEXMEDICA 10 mg/ml Infusionslösung
FR/H/0355/001 73831.00.00 PANMEDICA DE
PARACETAMOL ROTEXMEDICA 10 mg/ml Infusionslösung
FR/H/0355/001 73831.00.00 PANMEDICA DE
PARACETAMOL ROTEXMEDICA 10 mg/ml Infusionslösung
FR/H/0355/001 73831.00.00 PANMEDICA DE
PARACETAMOL ROTEXMEDICA 10 mg/ml Infusionslösung
FR/H/0355/001 73831.00.00 PANMEDICA DE
PARACETAMOL ROTEXMEDICA 10 mg/ml Infusionslösung
FR/H/0355/001 73831.00.00 PANMEDICA DE
PARACETAMOL ROTEXMEDICA 10 mg/ml Infusionslösung
FR/H/0355/001 73831.00.00 PANMEDICA DE
PARACETAMOL ROTEXMEDICA 10 mg/ml Infusionslösung
FR/H/0355/001 73831.00.00 PANMEDICA DE
PARACETAMOL ROTEXMEDICA 10 mg/ml Infusionslösung
FR/H/0355/001 73831.00.00 PANMEDICA DE
Paracetamol Sandoz (10mg/ml Solução para perfusão)
DE/H/3248/001 5474549 SANDOZ FARMACÊUTICA LDA.
PT
Paracetamol Sandoz (10mg/ml Solução para perfusão)
DE/H/3248/001 5474556 SANDOZ FARMACÊUTICA LDA.
PT
List of nationally authorised medicinal products EMA/819150/2016 Page 32/40
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Paracetamol Sandoz 10 mg/ml - Infusionslösung
DE/H/3248/001 1-31550 SANDOZ GMBH AT
Paracetamol Sandoz 10 mg/ml infuusioneste, liuos
DE/H/3248/001 30016 SANDOZ A/S FI
Paracetamol Sandoz 10 mg/ml oplossing voor infusie
DE/H/3248/001 BE426151 SANDOZ N.V. BE
Paracetamol Sandoz 10 mg/ml solution pour perfusion
DE/H/3248/001 2013110409 SANDOZ N.V. LU
Paracetamol Sandoz 10mg/ml solución para perfusion
DE/H/3248/001 76219 SANDOZ FARMACÉUTICA, S.A.
ES
Paracetamol Sandoz 10mg/ml solución para perfusion
DE/H/3248/001 76219 SANDOZ FARMACÉUTICA, S.A.
ES
Paracetamol TecniGen 10 mg/ml solución para perfusión EFG
PT/H/0554/001 75785 TECNIMEDE ESPAÑA IND. FCA., S.A.
ES
Paracetamol TecniGen 10 mg/ml solución para perfusión EFG
PT/H/0554/001 75785 TECNIMEDE ESPAÑA IND. FCA., S.A.
ES
Paracetamol TecniGen 10 mg/ml solución para perfusión EFG
PT/H/0554/001 75785 TECNIMEDE ESPAÑA IND. FCA., S.A.
ES
Paracetamol TecniGen 10 mg/ml solución para perfusión EFG
PT/H/0554/001 75785 TECNIMEDE ESPAÑA IND. FCA., S.A.
ES
Paracetamol Teva 10 mg/ml oplossing voor infusie
DE/H/3247/001 BE451244 TEVA PHARMA BELGIUM N.V./S.A
BE
Paracetamol Teva 10 mg/ml oplossing voor infusie
DE/H/3247/001 BE451244 TEVA PHARMA BELGIUM N.V./S.A
BE
Paracetamol Teva 10 mg/ml oplossing voor infusie
DE/H/3247/001 BE451244 TEVA PHARMA BELGIUM N.V./S.A
BE
Paracetamol Teva 10 mg/ml solution pour perfusion.
DE/H/3247/001 BE451244 TEVA PHARMA BELGIUM N.V./S.A
BE
List of nationally authorised medicinal products EMA/819150/2016 Page 33/40
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Paracetamol Teva 10 mg/ml solution pour perfusion.
DE/H/3247/001 BE474417 TEVA PHARMA BELGIUM N.V./S.A
BE
Paracetamol Teva 10 mg/ml solution pour perfusion.
DE/H/3247/001 BE474417 TEVA PHARMA BELGIUM N.V./S.A
BE
Paracetamol Teva 10 mg/ml solution pour perfusion.
DE/H/3247/001 BE451244 TEVA PHARMA BELGIUM N.V./S.A
BE
Paracetamol Teva 10 mg/ml solution pour perfusion.
DE/H/3247/001 BE474417 TEVA PHARMA BELGIUM N.V./S.A
BE
Paracetamol Teva 10 mg/ml solution pour perfusion.
DE/H/3247/001 BE474417 TEVA PHARMA BELGIUM N.V./S.A
BE
Paracetamol Teva 10 mg/ml solution pour perfusion.
DE/H/3247/001 BE451244 TEVA PHARMA BELGIUM N.V./S.A
BE
Paracetamol Teva 10 mg/ml solution pour perfusion.
DE/H/3247/001 BE474417 TEVA PHARMA BELGIUM N.V./S.A
BE
Paracetamol Teva 10 mg/ml solution pour perfusion.
DE/H/3247/001 BE474417 TEVA PHARMA BELGIUM N.V./S.A
BE
Paracetamol Teva 10mg/ml Infusionslösung
DE/H/3247/001 BE451244 TEVA PHARMA BELGIUM N.V./S.A
BE
Paracetamol Teva 10mg/ml Infusionslösung
DE/H/3247/001 BE474417 TEVA PHARMA BELGIUM N.V./S.A
BE
Paracetamol Teva 10mg/ml Infusionslösung
DE/H/3247/001 BE451244 TEVA PHARMA BELGIUM N.V./S.A
BE
Paracetamol Teva 10mg/ml Infusionslösung
DE/H/3247/001 BE474417 TEVA PHARMA BELGIUM N.V./S.A
BE
Paracetamol Teva 10mg/ml Infusionslösung
DE/H/3247/001 BE451244 TEVA PHARMA BELGIUM N.V./S.A
BE
Paracetamol Teva 10mg/ml Infusionslösung
DE/H/3247/001 BE474417 TEVA PHARMA BELGIUM N.V./S.A
BE
Paracetamol Teva 10mg/ml solution pour perfusion
DE/H/3247/01 2014120418 TEVA PHARMA BELGIUM N.V./S.A
LU
Paracetamol Teva 10mg/ml solution pour perfusion
DE/H/3247/01 2014120418 TEVA PHARMA BELGIUM N.V./S.A
LU
Paracetamol Teva 10mg/ml solution pour perfusion
DE/H/3247/01 2014120418 TEVA PHARMA BELGIUM N.V./S.A
LU
List of nationally authorised medicinal products EMA/819150/2016 Page 34/40
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Paracetamol Uni-Pharma 10 mg/ml solução para perfusão
NL/H/2857/001 5649728 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
PT
Paracetamol Uni-Pharma 10 mg/ml solução para perfusão
NL/H/2857/001 5649744 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
PT
Paracetamol Uni-Pharma 10 mg/ml solução para perfusão
NL/H/2857/001 5649751 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
PT
Paracetamol Uni-Pharma 10 mg/ml solução para perfusão
NL/H/2857/001 5649736 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
PT
Paracetamol Uni-Pharma 10 mg/ml Solution for Infusion
NL/H/2857/001 PL 20989/0010 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
UK
Paracetamol/Kabi 10 mg/ml διάλυμα για έγχυση
DE/H/2511/001 107177 FRESENIUS KABI HELLAS A.E.
GR
Paracetamol-Actavis 10 mg/ml Infusionslösung
DE/H/2210/001 76582.00.00 ACTAVIS GROUP PTC EHF. DE
Paracetamolo Aurobindo 10mg/ml soluzione per infusione
DE/H/2210/001/DC 039798018 AUROBINDO PHARMA (ITALIA) S.R.L.
IT
Paracetamolo Aurobindo 10mg/ml soluzione per infusione
DE/H/2210/001/DC 039798020 AUROBINDO PHARMA (ITALIA) S.R.L.
IT
Paracetamolo Aurobindo 10mg/ml soluzione per infusione
DE/H/2210/001/DC 039798032 AUROBINDO PHARMA (ITALIA) S.R.L.
IT
Paracetamolo Aurobindo 10mg/ml soluzione per infusione
DE/H/2210/001/DC 039798044 AUROBINDO PHARMA (ITALIA) S.R.L.
IT
Paracetamolo B. Braun 10 mg/ml soluzione per infusione
DE/H/3084/001 040798011 B.BRAUN MELSUNGEN AG IT
List of nationally authorised medicinal products EMA/819150/2016 Page 35/40
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Paracetamolo B. Braun 10 mg/ml soluzione per infusione
DE/H/3084/001 040798023 B.BRAUN MELSUNGEN AG IT
Paracetamolo B. Braun 10 mg/ml soluzione per infusione
DE/H/3084/001 040798035 B.BRAUN MELSUNGEN AG IT
Paracetamolo Kabi 10 mg/ml soluzione per infusione
DE/H/2511/001 040381028 FRESENIUS KABI ITALIA S.R.L.
IT
Paracetamolo Kabi 10 mg/ml soluzione per infusione
DE/H/2511/001 040381030 FRESENIUS KABI ITALIA S.R.L.
IT
Paracetamolo Kabi 10 mg/ml soluzione per infusione
DE/H/2511/001 040381042 FRESENIUS KABI ITALIA S.R.L.
IT
Paracetamolo Kabi 10 mg/ml soluzione per infusione
DE/H/2511/001 040381055 FRESENIUS KABI ITALIA S.R.L.
IT
Paracetamolo Kabi 10 mg/ml soluzione per infusione
DE/H/2511/001 040381067 FRESENIUS KABI ITALIA S.R.L.
IT
Paracetamolo Kabi 10 mg/ml soluzione per infusione
DE/H/2511/001 040381079 FRESENIUS KABI ITALIA S.R.L.
IT
Paracetamolo Kabi 10 mg/ml soluzione per infusione
DE/H/2511/001 040381081 FRESENIUS KABI ITALIA S.R.L.
IT
Paracetamolo Kabi 10 mg/ml soluzione per infusione
DE/H/2511/001 040381093 FRESENIUS KABI ITALIA S.R.L.
IT
Paracetamolo Kabi 10 mg/ml soluzione per infusione
DE/H/2511/001 040381105 FRESENIUS KABI ITALIA S.R.L.
IT
Paracetamolo Kabi 10 mg/ml soluzione per infusione
DE/H/2511/001 040381117 FRESENIUS KABI ITALIA S.R.L.
IT
List of nationally authorised medicinal products EMA/819150/2016 Page 36/40
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Paracetamolo Kabi 10 mg/ml soluzione per infusione
DE/H/2511/001 040381129 FRESENIUS KABI ITALIA S.R.L.
IT
Paracetamolo Kabi 10 mg/ml soluzione per infusione
DE/H/2511/001 040381131 FRESENIUS KABI ITALIA S.R.L.
IT
Paracetamolo Kabi 10 mg/ml soluzione per infusione
DE/H/2511/001 040381143 FRESENIUS KABI ITALIA S.R.L.
IT
Paracetamolo Kabi 10 mg/ml soluzione per infusione
DE/H/2511/001 040381016 FRESENIUS KABI ITALIA S.R.L.
IT
Paracetamolo Pharma Bavaria Internacional (PBI) Portugal 10 mg/ml Soluzione per infusione
DE/H/3247/001 041600014 PHARMA BAVARIA INTERNACIONAL PORTUGAL UNIP. LDA
IT
Paracetamolo Pharma Bavaria Internacional (PBI) Portugal 10 mg/ml Soluzione per infusione
DE/H/3247/001 041600026 PHARMA BAVARIA INTERNACIONAL PORTUGAL UNIP. LDA
IT
Paracetamolo Pharma Bavaria Internacional (PBI) Portugal 10 mg/ml Soluzione per infusione
DE/H/3247/001 041600038 PHARMA BAVARIA INTERNACIONAL PORTUGAL UNIP. LDA
IT
Parafusiv 10 mg/ml Solução para perfusão
not available 5423546 PHARMA BAVARIA INTERNACIONAL PORTUGAL UNIP. LDA
PT
Parafusiv 10 mg/ml Solução para perfusão
not available 5663059 PHARMA BAVARIA INTERNACIONAL PORTUGAL UNIP. LDA
PT
Parafusiv 10 mg/ml Solução para perfusão
not available 5663067 PHARMA BAVARIA INTERNACIONAL PORTUGAL UNIP. LDA
PT
List of nationally authorised medicinal products EMA/819150/2016 Page 37/40
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Parafusiv 10 mg/ml Solução para perfusão
not available 5663075 PHARMA BAVARIA INTERNACIONAL PORTUGAL UNIP. LDA
PT
Parafusiv 10 mg/ml Solução para perfusão
not available 5423553 PHARMA BAVARIA INTERNACIONAL PORTUGAL UNIP. LDA
PT
Perfalgan 10 mg/ml - Infusionslösung
FR/H/0197/001 1-24349 BRISTOL-MYERS SQUIBB GESMBH
AT
PERFALGAN 10 mg/ml Infusionslösung Wirkstoff: Paracetamol"
FR/H/0197/001 52600.00.00 BRISTOL-MYERS SQUIBB GMBH & CO. KGAA
DE
Perfalgan 10 mg/ml infuzinis tirpalas
FR/H/0197/001 LT/1/05/0219/001 BRISTOL-MYERS SQUIBB GYOGYSZERKERESKEDELMI KFT.
LT
Perfalgan 10 mg/ml infuzinis tirpalas
FR/H/0197/001 LT/1/05/0219/002 BRISTOL-MYERS SQUIBB GYOGYSZERKERESKEDELMI KFT.
LT
PERFALGAN 10 mg/ml solución para perfusión
FR/H/0197/001 64.535 BRISTOL-MYERS SQUIBB ES
PERFALGAN 10 mg/ml soluţie perfuzabilă
not available 6142/2006/01 BRISTOL-MYERS SQUIBB GYOGYSZERKERESKEDELMI KFT.
RO
PERFALGAN 10 mg/ml soluţie perfuzabilă
not available 6142/2006/02 BRISTOL-MYERS SQUIBB GYOGYSZERKERESKEDELMI KFT.
RO
PERFALGAN 10 mg/ml soluzione per infusione
FR/H/0197/001 035475019 BRISTOL-MYERS SQUIBB S.R.L.
IT
PERFALGAN 10 mg/ml soluzione per infusione
FR/H/0197/001 035475021 BRISTOL-MYERS SQUIBB S.R.L.
IT
PERFALGAN 10 mg/ml, infusioonilahus
FR/H/0197/001 469605 BRISTOL-MYERS SQUIBB GYOGYSZERKERESKEDELMI KFT.
EE
PERFALGAN 10 mg/ml, solution for infusion
FR/H/0197/001 PA 2/69/1 BRISTOL-MYERS SQUIBB PHARMACEUTICALS LIMITED
IE
PERFALGAN 10 mg/ml, solution for infusion
FR/H/0197/001 PL 11184/0094 BRISTOL-MYERS SQUIBB PHARMACEUTICALS LIMITED
UK
List of nationally authorised medicinal products EMA/819150/2016 Page 38/40
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
PERFALGAN 10 mg/ml, solution for infusion, polypropylene bag
FR/H/0197/001 PA 2/69/2 BRISTOL-MYERS SQUIBB PHARMACEUTICALS LIMITED
IE
PERFALGAN 10 mg/ml, solution pour perfusion
FR/H/0197/001 34009 563 059 1 9 BRISTOL-MYERS SQUIBB FR
Pinex 10mg/ml solution for infusion
DK/H/2668/001 44425 ACTAVIS GROUP PTC EHF. DK
Sinebriv DK/H/2668/001 17054 ACTAVIS GROUP PTC EHF. PL Supofen 10 mg/ml solução para perfusão
not available 5431606 LABORATÓRIOS BASI – INDÚSTRIA FARMACÊUTICA, S.A.
PT
Tachipirina 10 mg/ml soluzione per infusione
not available 012745232 AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO - A.C.R.A.F. S.P.A.
IT
Tachipirina 10 mg/ml soluzione per infusione
not available 012745244 AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO - A.C.R.A.F. S.P.A.
IT
Tachipirina 10 mg/ml soluzione per infusione
not available 012745257 AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO - A.C.R.A.F. S.P.A.
IT
Tachipirina 10 mg/ml soluzione per infusione
not available 012745269 AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO - A.C.R.A.F. S.P.A.
IT
Wegmal 10mg/ml infuusioneste, liuos
DE/H/3247/001/DC 30023 NEOGEN N.V. FI
Парацетамол Б. Браун 10 mg/ml инфузионен разтвор
DE/H/3084/001 20120293 B.BRAUN MELSUNGEN AG BG
Парацетамол БИОФАРМ 10 mg/ml инфузионен разтвор
not available 20140040 BIOPHARM ENGINEERING BG
Парацетамол Каби 10 mg/ml инфузионен разтвор
DE/H/2511/001 20120453 FRESENIUS KABI BULGARIA EOOD
BG
List of nationally authorised medicinal products EMA/819150/2016 Page 39/40
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
ПАРАЦЕТАМОЛ ПAHФAPMA 10 mg/ml инфузионен разтвор
FR/H/0355/001 2011069 PANMEDICA BG
ПАРАЦЕТАМОЛ ПAHФAPMA 10 mg/ml инфузионен разтвор
FR/H/0355/001 2011069 PANMEDICA BG
ПАРАЦЕТАМОЛ ПAHФAPMA 10 mg/ml инфузионен разтвор
FR/H/0355/001 2011069 PANMEDICA BG
ПАРАЦЕТАМОЛ ПAHФAPMA 10 mg/ml инфузионен разтвор
FR/H/0355/001 2011069 PANMEDICA BG
ПАРАЦЕТАМОЛ ПAHФAPMA 10 mg/ml инфузионен разтвор
FR/H/0355/001 2011069 PANMEDICA BG
ПАРАЦЕТАМОЛ ПAHФAPMA 10 mg/ml инфузионен разтвор
FR/H/0355/001 2011069 PANMEDICA BG
ПАРАЦЕТАМОЛ ПAHФAPMA 10 mg/ml инфузионен разтвор
FR/H/0355/001 2011069 PANMEDICA BG
ПАРАЦЕТАМОЛ ПAHФAPMA 10 mg/ml инфузионен разтвор
FR/H/0355/001 2011069 PANMEDICA BG
ПАРАЦЕТАМОЛ ПAHФAPMA 10 mg/ml инфузионен разтвор
FR/H/0355/001 2011069 PANMEDICA BG
ПАРАЦЕТАМОЛ ПAHФAPMA 10 mg/ml инфузионен разтвор
FR/H/0355/001 2011069 PANMEDICA BG
ПАРАЦЕТАМОЛ ПAHФAPMA 10 mg/ml инфузионен разтвор
FR/H/0355/001 2011069 PANMEDICA BG
ПАРАЦЕТАМОЛ ПAHФAPMA 10 mg/ml инфузионен разтвор
FR/H/0355/001 2011069 PANMEDICA BG
List of nationally authorised medicinal products EMA/819150/2016 Page 40/40
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
ПЕРФАЛГАН 10 mg/ml инфузионен разтвор
not available 20020869 BRISTOL-MYERS SQUIBB GYOGYSZERKERESKEDELMI KFT.
BG
Paracetamol-ratiopharm® 10 mg/ml Infusionslösung
DE/H/1908/001 74700.00.00 RATIOPHARM GMBH DE
Paracetamol 10 mg/ml Teva, oplossing voor infusie
DE/H/1908/001 RVG 108752 TEVA NEDERLAND B.V. NL
Paracetamol 10 mg/ml Solution for Infusion.
DE/H/1908/001 PA 749/145/1 TEVA PHARMA B.V. IE
Парацетамол Тева 10 mg/ml инфузионен разтвор
DE/H/1908/001 20120212 TEVA PHARMACEUTICALS BULGARIA EOOD
BG
