List of nationally authorised medicinal products ... · Edemid NP/H/0337/001 H/92/00524/001 Lek...
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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 5555 Send a question via our website www.ema.europa.eu/contact © European Medicines Agency, 2015. Reproduction is authorised provided the source is acknowledged. 23 September 2015 EMA/729829/2015 Procedure Management and Committees Support List of nationally authorised medicinal products Active substance: furosemide Procedure no.: PSUSA/00001491/201501
Transcript of List of nationally authorised medicinal products ... · Edemid NP/H/0337/001 H/92/00524/001 Lek...
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 5555 Send a question via our website www.ema.europa.eu/contact
© European Medicines Agency, 2015. Reproduction is authorised provided the source is acknowledged.
23 September 2015 EMA/729829/2015 Procedure Management and Committees Support
List of nationally authorised medicinal products
Active substance: furosemide
Procedure no.: PSUSA/00001491/201501
List of nationally authorised medicinal products EMA/729829/2015 Page 2/26
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
Diretif UK/H/1241/01/DC 039004015 Claris Lifesciences (Uk) Limited IT
Diretif UK/H/1241/01/DC 039004027 Claris Lifesciences (Uk) Limited IT
Diural 06563 06563 Actavis Group Hf. DK
Diural 06564 06564 Actavis Group Hf. DK
Diural 06565 06565 Actavis Group Hf. DK
Diural 10286 10286 Actavis Group Hf. DK
Diural 10506 10506 Actavis Group Hf. DK
Diural 5619 5619 Actavis Group Hf. NO
Diural 5998 5998 Actavis Group Hf. NO
Diural 5999 5999 Actavis Group Hf. NO
Diural 6691 6691 Actavis Group Hf. NO
Diurapid 39275.00.00 Mibe Gmbh Arzneimittel DE
Edemid NOT APPLICABLE UP/I-530-09/06-02/207 Sandoz D.O.O. HR
Edemid NOT APPLICABLE UP/I-530-09/12-01/386 Sandoz D.O.O. HR
Edemid NP/H/0337/001 H/92/00524/001 Lek Pharmaceuticals D.D. Ljubljana SI
Edemid NP/H/0337/002 H/92/00524/002 Lek Pharmaceuticals D.D. Ljubljana SI
Edemid NP/H/0337/003 H/92/00524/003 Lek Pharmaceuticals D.D. Ljubljana SI
Edemid NP/H/0337/004 H/92/00524/004 Lek Pharmaceuticals D.D. Ljubljana SI
List of nationally authorised medicinal products EMA/729829/2015 Page 3/26
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
Fruside PA0281/087/001 Pinewood Laboratories Limited IE
Frusol PL 00427/0109 Rosemont Pharmaceuticals Limited GB
Frusol PL 00427/0110 Rosemont Pharmaceuticals Limited GB
Frusol PL 00427/0111 Rosemont Pharmaceuticals Limited GB
Fudesix S00982/13-3-2014 Montechem Pharma Ltd CY
Fudesix 28224/30-4-2008 Help S.A. GR
Fudesix 28225/30-4-2008 Help S.A. GR
Fudesix 28226/30-4-2008 Help S.A. GR
Furanthril 20000377 20000377 Actavis Ead BG
Furanthril 37182.00.00 Medphano Arzneimittel Gmbh DE
Furesis 2675 Orion Oyj FI
Furesis 4351 Orion Oyj FI
Furesis 7115 Orion Oyj FI
Furesis 8681 Orion Oyj FI
Furesis Special 6908 Orion Oyj FI
Furix 10050 Takeda Pharma A/S DK
Furix 12750 Takeda Pharma A/S DK
Furix 31465 Takeda Pharma A/S DK
List of nationally authorised medicinal products EMA/729829/2015 Page 4/26
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
Furix 9898 Takeda Pharma A/S DK
Furix 9899 Takeda Pharma A/S DK
Furix IS/1/03/005/01 Takeda Pharma A/S IS
Furix IS/1/03/005/02 Takeda Pharma A/S IS
Furix IS/1/03/006/01 Takeda Pharma A/S IS
Furix 6816 Takeda Nycomed As NO
Furix 6817 Takeda Nycomed As NO
Furix 6818 Takeda Nycomed As NO
Furix 7324 Takeda Nycomed As NO
Furix 10496 Takeda Pharma Ab SE
Furix 9548 Takeda Pharma Ab SE
Furix 9550 Takeda Pharma Ab SE
Furix Retard 13652 Takeda Pharma A/S DK
Furix Retard 13653 Takeda Pharma A/S DK
Furix Retard 7909 Takeda Nycomed As NO
Furix Retard 7910 Takeda Nycomed As NO
Furix Retard 14076 Takeda Pharma Ab SE
Furix Retard 14077 Takeda Pharma Ab SE
List of nationally authorised medicinal products EMA/729829/2015 Page 5/26
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
Furix Retard 9549 Takeda Pharma Ab SE
Furobeta 2137314 37314.00.00 Betapharm Arzneimittel Gmbh DE
Furobeta 2137634 37634.00.00 Betapharm Arzneimittel Gmbh DE
Furobeta 284 37182.01.00 Betapharm Arzneimittel Gmbh DE
Furo-Ct 41655.00.00 Abz-Pharma Gmbh, Graf-Arco-Str. 3 DE
Furo-Ct 49538.00.00 Abz-Pharma Gmbh, Graf-Arco-Str. 3 DE
Furo-Ct 6068311.00.00 Abz-Pharma Gmbh, Graf-Arco-Str. 3 DE
Furohexal 936.729 1-22065 Hexal Pharma Gmbh AT
Furohexal 936.730 1-22066 Hexal Pharma Gmbh AT
Furohexal 943.661 1-24357 Hexal Pharma Gmbh AT
Furon 1-20060 Ratiopharm Arzneimittel Vertriebs-Gmbh AT
Furon 1-20066 Ratiopharm Arzneimittel Vertriebs-Gmbh AT
Furon 1-20075 Ratiopharm Arzneimittel Vertriebs-Gmbh AT
Furon 1-22596 Ratiopharm Arzneimittel Vertriebs-Gmbh AT
Furon 1-23980 Ratiopharm Arzneimittel Vertriebs-Gmbh AT
Furon 50/233/92-C Ratiopharm Gmbh CZ
Furon OGYI-T-5554/01 Teva Gyógyszergyár Zrt HU
Furon OGYI-T-5554/02 Teva Gyógyszergyár Zrt HU
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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
Furon OGYI-T-5554/03 Teva Gyógyszergyár Zrt HU
Furon OGYI-T-5554/04 Teva Gyógyszergyár Zrt HU
Furon OGYI-T-5554/05 Teva Gyógyszergyár Zrt HU
Furon 50/0233/92-C/S Ratiopharm Gmbh SK
Furo-Puren 40596.00.00 Actavis Deutschland Gmbh & Co. Kg DE
Furo-Puren 41652.00.00 Actavis Deutschland Gmbh & Co. Kg DE
Furorese 1325/97 50/047/99-C Hexal Ag CZ
Furorese 1326/97 50/048/99-C Hexal Ag CZ
Furorese 1327/97 50/049/99-C Hexal Ag CZ
Furorese 1328/97 50/050/99-C Hexal Ag CZ
Furorese 1329/97 50/119/99-C Hexal Ag CZ
Furorese 0938781 6913686.01.00 Hexal Ag DE
Furorese 2107259 7259.00.00 Hexal Ag DE
Furorese 2107283 7259.00.02 Hexal Ag DE
Furorese 2107593 7259.00.01 Hexal Ag DE
Furorese 2127324 27324.00.00 Hexal Ag DE
Furorese 2127325 27324.01.00 Hexal Ag DE
Furorese 2127326 27324.02.00 Hexal Ag DE
List of nationally authorised medicinal products EMA/729829/2015 Page 7/26
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
Furorese 2137633 37633.00.00 Hexal Ag DE
Furorese 2137865 37865.00.00 Hexal Ag DE
Furorese 2139036 39036.00.00 Hexal Ag DE
Furorese 2145062 37865.01.00 Hexal Ag DE
Furorese 47265 0628018 Hexal Ag LU
Furorese 47265 0715/03058098 Hexal Ag LU
Furorese 0715/02/01/8097 Hexal Ag LU
Furorese 240/1997/1 50/0147/02-S Hexal Ag SK
Furorese 240/1997/3 50/0149/02-S Hexal Ag SK
Furorese Comp 7579.01.00 Hexal AG DE
Furorese Comp 7579.00.00 Hexal AG DE
Furosemid 44063.00.00 Abz-Pharma Gmbh, Graf-Arco-Str. 3 DE
Furosemid OGYI-T-3371/01 Sanofi-Aventis Private Co Ltd HU
Furosemid OGYI-T-3371/02 Sanofi-Aventis Private Co Ltd HU
Furosemid OGYI-T-3371/03 Sanofi-Aventis Private Co Ltd HU
Furosemid OGYI-T-3371/04 Sanofi-Aventis Private Co Ltd HU
Furosemid OGYI-T-3371/05 Sanofi-Aventis Private Co Ltd HU
Furosemid 1 A Pharma 2137315 37315.00.00 1 A Pharma Gmbh DE
List of nationally authorised medicinal products EMA/729829/2015 Page 8/26
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
Furosemid 1 A Pharma 2137630 37630.00.00 1 A Pharma Gmbh DE
Furosemid 1 A Pharma 2137866 37866.00.00 1 A Pharma Gmbh DE
Furosemid 1 A Pharma 2140792 40792.00.00 1 A Pharma Gmbh DE
Furosemid 1a Pharma 945.839 1-24615 1a Pharma Gmbh AT
Furosemid Acis 36818.00.00 Acis Arzneimittel Gmbh DE
Furosemid Acis 44061.00.00 Acis Arzneimittel Gmbh DE
Furosemid Aliud Pharma 2912.00.00 Aliud Pharma Gmbh DE
Furosemid Aliud Pharma 43907.00.00 Aliud Pharma Gmbh DE
Furosemid Arena 80/2007/01-02 Arena Group S.A RO
Furosemid Biotika 50/804/92-S/C Bb Pharma A.S. CZ
Furosemid Biotika 50/0804/92-S Bb Pharma A.S. SK
Furosemid Claris UK/H/1241/01/DC 42443 Claris Lifesciences (Uk) Limited DK
Furosemid Copyfarm UK/H/0754/001 37897 Copyfarm A/S DK
Furosemid Copyfarm UK/H/0754/002 37898 Copyfarm A/S DK
Furosemid Copyfarm UK/H/0754/001 22405 Copyfarm A/S SE
Furosemid Copyfarm UK/H/0754/002 22406 Copyfarm A/S SE
Furosemid Dura 3461.00.00 Mylan Dura Gmbh DE
Furosemid Forte Biotika 50/766/92-S/C Bb Pharma A.S. CZ
List of nationally authorised medicinal products EMA/729829/2015 Page 9/26
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
Furosemid Forte Biotika 50/0766/92-S Bb Pharma A.S. SK
Furosemid Genericon 1-18995 Genericon Pharma Gesellschaft M.B.H. AT
Furosemid Hexal DE/H/0517/001 37183.00.00 Hexal Ag DE
Furosemid Hexal DE/H/0517/001 38055 Hexal A/S DK
Furosemid Hexal DE/H/0517/001 22554 Hexal A/S SE
Furosemid Kabi PT/H/0141/001 50/294/07-C Fresenius Kabi S.R.O Czech Republic CZ
Furosemid Kabi PT/H/0141/001 50/0249/07-S Fresenius Kabi S.R.O Czech Republic SK
Furosemid Lph 6906/2006/01-02 Labormed Pharma S.A. RO
Furosemid Mcc 81/2007/01 Magistra C&c RO
Furosemid Nycomed 230298 Takeda Pharma As EE
Furosemid Orion 6227 Orion Corporation NO
Furosemid Orion 6683 Orion Corporation NO
Furosemid Orion 6684 Orion Corporation NO
Furosemid Polpharma LT/1/94/0890/001 Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna LT
Furosemid Polpharma LT/1/94/0934/001 Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna LT
Furosemid Ratiopharm 234.00.01 Ratiopharm Gmbh DE
Furosemid Ratiopharm 0687/03/12/7946 Ratiopharm Gmbh LU
Furosemid Ratiopharm 0687/03/12/7947 Ratiopharm Gmbh LU
List of nationally authorised medicinal products EMA/729829/2015 Page 10/26
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
Furosemid Ratiopharm 0687/03/12/7948 Ratiopharm Gmbh LU
Furosemid Recip 9747 Recip Ab SE
Furosemid Recip 9748 Recip Ab SE
Furosemid Recip 9749 Recip Ab SE
Furosemid Recip 9750 Recip Ab SE
Furosemid Sandoz 2140597 40597.00.00 Hexal Ag DE
Furosemid Sandoz 2144065 44065.00.00 Hexal Ag DE
Furosemid Slavia 79/2007/01-02 Slavia Pharm Srl RO
Furosemid Slovakofarma 50/052/73-S/C Zentiva A.S. CZ
Furosemid Slovakofarma 50/0052/73-S Zentiva, A.S. SK
Furosemid Slovakofarma 50/0407/69-S Zentiva, A.S. SK
Furosemid Stadapharm 265.00.00 Stadapharm Gmbh DE
Furosemid Stadapharm 34140.00.00 Stadapharm Gmbh DE
Furosemid Stadapharm 41653.00.00 Stadapharm Gmbh DE
Furosemid Zentiva 3515/2011/01 S.C. Zentiva S.A. RO
Furosemid Zentiva 69/2007/01 S.C. Zentiva S.A. RO
Furosemid Zentiva 3515/2011/02 S.C. Zentiva S.A. RO
Furosemida Apotex 40 Mg 64141 Apotex Europe Bv ES
List of nationally authorised medicinal products EMA/729829/2015 Page 11/26
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
Furosemida Basi 3456688 Laboratórios Basi – Indústria Farmacêutica, S.A. PT
Furosemida Basi 5039656 Laboratórios Basi – Indústria Farmacêutica, S.A. PT
Furosemida Basi 5039664 Laboratórios Basi – Indústria Farmacêutica, S.A. PT
Furosemida Bexal 04/9518 68.078 Bexal Farmacéutica S.A. ES
Furosemida Cinfa 64140 Laboratorios Cinfa, S.A. ES
Furosemida Cinfa 5355987 Cinfa Portugal, Lda. PT
Furosemida Cinfa 5356084 Cinfa Portugal, Lda. PT
Furosemida Cinfa 5356183 Cinfa Portugal, Lda. PT
Furosemida Cinfa 5356282 Cinfa Portugal, Lda. PT
Furosemida Cinfa 5578083 Cinfa Portugal, Lda. PT
Furosemida Fresenius Kabi PT/H/0141/001 69.097 Fresenius Kabi España S.A.U. ES
Furosemida Fresenius Kabi PT/H/0141/001 3871191 Fresenius Kabi Pharma Portugal Lda. PT
Furosemida Fresenius Kabi PT/H/0141/001 3871290 Fresenius Kabi Pharma Portugal Lda. PT
Furosemida Fresenius Kabi PT/H/0141/001 3871399 Fresenius Kabi Pharma Portugal Lda. PT
Furosemida Inibsa 62168 Inibsa Hospital S.L.U. ES
Furosemida Kern Pharma 69.620 Kern Pharma, S.L. ES
Furosemida Labesfal 3871498 Labesfal Laboratorios Almiro, S.A. PT
Furosemida Labesfal 3871597 Labesfal Laboratorios Almiro, S.A. PT
List of nationally authorised medicinal products EMA/729829/2015 Page 12/26
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
Furosemida Labesfal 3871696 Labesfal Laboratorios Almiro, S.A. PT
Furosemida Mylan 72237 Mylan Pharmaceuticals S.L. ES
Furosemida Pharmakern 5124045
Pharmakern Portugal – Produtos Farmacêuticos, Sociedade Unipessoal, Lda. PT
Furosemida Pharmakern 5124052
Pharmakern Portugal – Produtos Farmacêuticos, Sociedade Unipessoal, Lda. PT
Furosemida Pharmakern 5124060
Pharmakern Portugal – Produtos Farmacêuticos, Sociedade Unipessoal, Lda. PT
Furosemida Pharmakern 5124078
Pharmakern Portugal – Produtos Farmacêuticos, Sociedade Unipessoal, Lda. PT
Furosemida Pharmakern 5124102
Pharmakern Portugal – Produtos Farmacêuticos, Sociedade Unipessoal, Lda. PT
Furosemida Ratiopharm 4514881 Ratiopharm Lda PT
Furosemida Ratiopharm 4514683 Ratiopharm Lda PT
Furosemida Ratiopharm 4514782 Ratiopharm Lda PT
Furosemida Ratiopharm 5505284 Ratiopharm Lda PT
Furosemida Reig Jofre 65.486 Laboratorio Ramon Sala, S.L ES
Furosemida Reig Jofré 65487 Laboratorio Ramon Sala, S.L ES
Furosemida Sala 65540 Laboratorio Ramon Sala, S.L ES
Furosemida Sala 65541 Laboratorio Ramon Sala, S.L ES
Furosemida Sandoz 04/9516 68077 Sandoz Farmacéutica, S.A. ES
List of nationally authorised medicinal products EMA/729829/2015 Page 13/26
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
Furosemida Sandoz DE/H/0517/001 5743885 Sandoz Farmaceutica LDA. PT
Furosemida Sandoz DE/H/0517/001 5743984 Sandoz Farmaceutica LDA. PT
Furosemida Zentiva 4622494 Sanofi - Produtos Farmaceuticos Lda PT
Furosemida Zentiva 4622593 Sanofi - Produtos Farmaceuticos Lda PT
Furosemida Zentiva 5632260 Sanofi - Produtos Farmaceuticos Lda PT
Furosemide PL 00289/0185 Teva Uk Limited Brampton Road, Hampden Park GB
Furosemide PL 00289/0417 Teva Uk Limited Brampton Road, Hampden Park GB
Furosemide PL 00289/0818 Teva Uk Limited Brampton Road, Hampden Park GB
Furosemide PL 16201/0013 Mercury Pharma (Generics) Ltd. GB
Furosemide PL 16201/0014 Mercury Pharma (Generics) Ltd. GB
Furosemide EE-H-0154-001-DC PL 00289/1420 Teva Uk Limited Brampton Road, Hampden Park GB
Furosemide UK/H/1241/01/DC PL 20568/0010 Claris Lifesciences (Uk) Limited GB
Furosemide PL 4096/0043 Brill Pharma Limited GB
Furosemide PL 4096/0044 Brill Pharma Limited GB
Furosemide PA 73/59/4 Mercury Pharmaceuticals (Ireland) Ltd. IE
Furosemide PA 73/59/5 Mercury Pharmaceuticals (Ireland) Ltd. IE
Furosemide PA 73/59/6 Mercury Pharmaceuticals (Ireland) Ltd. IE
Furosemide UK/H/1241/01/DC PA 1389/005/001 Claris Lifesciences (Uk) Limited IE
List of nationally authorised medicinal products EMA/729829/2015 Page 14/26
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
Furosemide MA 079/00602 Mercury Pharma International Ltd MT
Furosemide MA079/00601 Mercury Pharma International Ltd MT
Furosemide MA079/00603 Mercury Pharma International Ltd MT
Furosemide PL274/00401A Goldshield Pharmaceuticals Ltd. MT
Furosemide AA737/01301 Bristol Laboratories Ltd (Berkhamsted) MT
Furosemide 20 Mg 04556/0042 Pharmvit Limited GB
Furosemide 20 Pch RVG 10185 Pharmachemie B.V. NL
Furosemide 40 Pch RVG 09511 Pharmachemie B.V. NL
Furosemide 500 Mg Teva EE-H-0154-001-DC RVG 106750 Teva Nederland B.V. NL Furosemide 50mg/5ml Solution For Injection PL 2848/0103 Mercury Pharma International Ltd GB
Furosemide Abz 30028.00.00 Abz-Pharma Gmbh, Graf-Arco-Str. 3 DE
Furosemide Abz 9937.00.00 Abz-Pharma Gmbh, Graf-Arco-Str. 3 DE
Furosemide Accord IE/H/186/001/MR PL 20075/0339 Accord Healthcare Limited GB
Furosemide Accord IE/H/186/001/MR PA 1390/049/001 Accord Healthcare Limited IE
Furosemide Accord IE/H/186/001/MR PA 1390/049/002 Accord Healthcare Limited IE
Furosemide Actavis RVG 08705 Actavis B.V. NL
Furosemide Actavis Uk Ltd. 0142/0090 0142/0090 Actavis Uk Ltd. GB
Furosemide Actavis Uk Ltd. 0142/0091 0142/0091 Actavis Uk Ltd. GB
List of nationally authorised medicinal products EMA/729829/2015 Page 15/26
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
Furosemide Actavis Uk Ltd. 0142/0371 0142/0371 Actavis Uk Ltd. GB
Furosemide Angenerico 035979018 Angenerico Spa IT
Furosemide Apotex 40 Mg RVG 53385 Apotex Europe Bv NL
Furosemide Arrow NL 29508 NL 29508 Arrow Generiques FR
Furosemide Arrow NL 29509 NL 29509 Arrow Generiques FR
Furosemide Aurobindo PL 20532/0039 Aurobindo Pharma Limited GB
Furosemide Aurobindo PL 20532/0040 Aurobindo Pharma Limited GB
Furosemide Bil 031875014 Biologici Italia Laboratories S.R.L IT
Furosemide Cf RVG 55472 Centrafarm B.V. NL
Furosemide Cf RVG 55322 Centrafarm B.V. NL
Furosemide Cf RVG 57091 Centrafarm B.V. NL
Furosemide Claris UK/H/1241/01/DC RVG 101495 Claris Lifesciences (Uk) Limited NL
Furosemide Claris UK/H/1241/01/DC 07/5406 Claris Lifesciences (Uk) Limited NO
Furosemide Claris UK/H/1241/01/DC 26329 Claris Lifesciences (Uk) Limited SE Furosemide Clonmel Healthcare PA0126/008/001 Clonmel Healthcare Limited IE Furosemide Clonmel Healthcare PA0126/008/002 Clonmel Healthcare Limited IE Furosemide Crescent Pharma Limited PL 20416/0078 Crescent Pharma Limited GB Furosemide Crescent Pharma Limited PL 20416/0079 Crescent Pharma Limited GB
List of nationally authorised medicinal products EMA/729829/2015 Page 16/26
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
Furosemide Crescent Pharma Limited PL 20415/0384 Crescent Pharma Limited GB
Furosemide Ct 30031.00.00 Abz-Pharma Gmbh, Graf-Arco-Str. 3 DE
Furosemide Ct 9191.00.00 Abz-Pharma Gmbh, Graf-Arco-Str. 3 DE
Furosemide Doc Generici 035213 Doc Generici S.R.L. IT
Furosemide Evolugen NL 12237 Evolupharm FR Furosemide Focus Pharmaceuticals PL 20046/0037 Focus Pharmaceuticals Limited GB Furosemide Focus Pharmaceuticals PL 20046/0038 Focus Pharmaceuticals Limited GB Furosemide Focus Pharmaceuticals PL 20046/0039 Focus Pharmaceuticals Limited GB
Furosemide Fresenius Kabi PT/H/0141/001 BE300045 Fresenius Kabi N.V./S.A. Belgium BE
Furosemide Fresenius Kabi PT/H/0141/001 22931 Fresenius Kabi Ab Uppsala, Sweden FI
Furosemide Fresenius Kabi PT/H/0141/001 PL 08828/0179 Fresenius Kabi Limited Uk GB
Furosemide Fresenius Kabi PT/H/0141/001 14082/23-02-2012 Fresenius Kabi Hellas A.E. GR
Furosemide Fresenius Kabi PT/H/0141/001 PA 566/41/1 Fresenius Kabi Limited Uk IE
Furosemide Fresenius Kabi PT/H/0141/001 RVG 34774 Fresenius Kabi Nederland B.V. NL Furosemide Hameln Pharmaceuticals PL 1502/0032 Hameln Pharmaceuticals Ltd GB Furosemide Hameln Pharmaceuticals Ltd S00503 Hameln Pharmaceuticals Ltd CY
Furosemide Hexal 032898 032898013 Hexal S.P.A IT
Furosemide Hexal 032898 032898025 Hexal S.P.A IT
List of nationally authorised medicinal products EMA/729829/2015 Page 17/26
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
Furosemide Hexal 032898 032898037 Hexal S.P.A IT Furosemide Injection Bp Minijet International Medication Systems PL 03265/0025
International Medication Systems, Limited GB
Furosemide Injection Bp Minijet International Medication Systems PA 255/10/4
International Medication System (Slough Gb) IE
Furosemide Italfarmaco 030160028 Italfarmaco S.P.A IT
Furosemide Kabi PT/H/0141/001 14348 Fresenius Kabi Pharma Portugal Lda. PL
Furosémide Kabi PT/H/0141/001 NL 33 645 Fresenius Kabi France S.A.S. FR
Furosemide L.F.M. 030210013 Laboratorio Farmacologico Milanese S.R.L. IT
Furosemide Laboratorio Reig Jofré PL 25174/0005 Laboratorio Reig Jofre, S.A. GB
Furosemide Lavoisier NL23443-3400956185610 Laboratoires Chaix Et Du Marais FR
Furosemide Mylan BE181361 Mylan Bvba/Sprl BE
Furosemide Mylan NAT/H/1364/001 2004018092 Mylan Bvba/Sprl LU
Furosemide Mylan RVG 27917=53385 Mylan B.V. NL
Furosémide Mylan NL 29 510 Mylan S.A.S FR
Furosémide Mylan NL 29 511 Mylan S.A.S FR
Furosemide Mylan Generics 035211010 Mylan S.P.A. IT
Furosemide Mylan Generics 035211046 Mylan S.P.A. IT
Furosemide Mylan Generics 035211061 Mylan S.P.A. IT
List of nationally authorised medicinal products EMA/729829/2015 Page 18/26
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
Furosemide Mylan Generics 035211073 Mylan S.P.A. IT
Furosemide Ratiopharm 36544.00.00 Ratiopharm Gmbh DE
Furosemide Ratiopharm 41654.00.00 Ratiopharm Gmbh DE
Furosemide Ratiopharm 45266.00.00 Ratiopharm Gmbh DE
Furosemide Ratiopharm 45266.01.00 Ratiopharm Gmbh DE
Furosemide Ratiopharm 45266.02.00 Ratiopharm Gmbh DE
Furosemide Ratiopharm 6306302.00.00 Ratiopharm Gmbh DE
Furosemide Ratiopharm RVG 55844 Ratiopharm Nederland B.V. Swensweg 5 NL
Furosemide Ratiopharm 11184 Teva Sweden Ab SE
Furosemide Sandoz NAT/H/5190/001 BE285187 Sandoz N.V. BE
Furosemide Sandoz NL 28078 361 698-3 Sandoz FR
Furosemide Sandoz NL 28078 368 190-5 Sandoz FR
Furosemide Sandoz NL 28078 372 938-0 Sandoz FR
Furosemide Sandoz NL 28078 564 312-2 Sandoz FR
Furosemide Sandoz NL 28079 361 701-4 Sandoz FR
Furosemide Sandoz NL 28079 368 196-3 Sandoz FR
Furosemide Sandoz NL 28079 372 939-7 Sandoz FR
Furosemide Sandoz NL 28079 564 313-9 Sandoz FR
List of nationally authorised medicinal products EMA/729829/2015 Page 19/26
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
Furosemide Sandoz RVG 20519 RVG 20519 Sandoz B.V. NL
Furosemide Sandoz RVG 25839 RVG 25839 Sandoz B.V. NL
Furosemide Sandoz RVG 25840 RVG 25840 Sandoz B.V. NL
Furosemide Sandoz RVG 25841 RVG 25841 Sandoz B.V. NL Furosemide Sodium Ratiopharm 234.00.01 Ratiopharm Gmbh DE Furosemide Sodium Ratiopharm 5941.00.00 Ratiopharm Gmbh DE
Furosemide Tablets UK/H/754/01 PL 17907/0018 Bristol Laboratories Ltd (Berkhamsted) GB
Furosemide Tablets UK/H/754/02 PL 17907/0019 Bristol Laboratories Ltd (Berkhamsted) GB
Furosemide Tablets PL 04569/0113 Generics (UK) Ltd t/a Mylan GB
Furosemide Tablets PL 04569/0114 Generics (UK) Ltd t/a Mylan GB
Furosemide Tablets PL 04569/0115 Generics (UK) Ltd t/a Mylan GB
Furosemide Tablets UK/H/754/01 PA 1240/001/001 Bristol Laboratories Ltd (Berkhamsted) IE
Furosemide Tablets UK/H/754/02 PA 1240/001/002 Bristol Laboratories Ltd (Berkhamsted) IE
Furosemide Tablets UK/H/754/01 RVG 32462 Bristol Laboratories Ltd (Berkhamsted) NL
Furosemide Tablets UK/H/754/02 RVG 32463 Bristol Laboratories Ltd (Berkhamsted) NL
Furosemide Tablets 40 Mg 04556/0003 Pharmvit Limited GB
Furosemide Teva EE-H-0154-001-DC 732011 Teva Pharma B.V. Computerweg 10 EE
Furosemide Teva EE-H-0154-001-DC 040642011/M Teva Italia S.R.L. IT
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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
Furosemide Teva EE-H-0154-001-DC 040642023/M Teva Italia S.R.L. IT
Furosemide Teva EE-H-0154-001-DC 040642035/M Teva Italia S.R.L. IT
Furosemide Teva EE-H-0154-001-DC 040642047/M Teva Italia S.R.L. IT
Furosemide Teva EE-H-0154-001-DC 040642050/M Teva Italia S.R.L. IT
Furosemide Teva EE-H-0154-001-DC 040642062/M Teva Italia S.R.L. IT
Furosemide Teva EE-H-0154-001-DC 040642074/M Teva Italia S.R.L. IT
Furosémide Teva NL26851 Teva Santé FR
Furosémide Teva NL39628 Teva Santé FR
Furosemide Teva Generics 035206010 Pharmacare Srl IT
Furosemide Teva Generics 035206034 Pharmacare Srl IT
Furosemide Unifarma 12-0219 Sia Unifarma LV Furosemide Wockhardt Uk Ltd 29831/0098 Wockhardt Uk Ltd GB Furosemide Wockhardt Uk Ltd 29831/0201 Wockhardt Uk Ltd GB Furosemide Wockhardt Uk Ltd AA154/05001 Wockhardt Uk Ltd MT Furosemide Wockhardt Uk Ltd AA154/05002 Wockhardt Uk Ltd MT
Furosemide Zentiva NL 12751 Sanofi-Aventis France FR
Furosemide Zentiva NL 12752 Sanofi-Aventis France FR
Furosemide Zentiva NL 44918 Sanofi-Aventis France FR
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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
Furosemid-Ratiopharm OGYI-T-8857/01 Teva Gyógyszergyár Zrt HU
Furosemid-Ratiopharm OGYI-T-8857/02 Teva Gyógyszergyár Zrt HU
Furosemīds Olainfarm 98-0192 Jsc Olainfarm LV
Furosemidum R/1350 Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna PL
Furosemidum Polpharma R/0451 Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna PL
Furoser II-1764 Tchaikapharma High Quality Medicines, Inc. BG
Fursemid Belupo, Lijekovi I Kozmetika UP/I-530-09/09-02/249 Belupo D.D. HR Fursemid Belupo, Lijekovi I Kozmetika UP/I-530-09/09-02/253 Belupo D.D. HR
Fursemid Forte UP/I-530-09/09-02/252 Belupo D.D. HR
Fusid 37183.01.00 Teva Gmbh DE
Fusid 6805577.00.00 Teva Gmbh DE
Hydroflux 45715/14.10.2013 Ioulia And Irene Tseti Pharmaceutical Laboratories S.A. GR
Hydroflux 78957/14.10.2013 Ioulia And Irene Tseti Pharmaceutical Laboratories S.A. GR
Impugan SE/H/1341/001 IS/1/13/039/03 Actavis Group Hf. IS
Impugan SE/H/1341/002 IS/1/13/039/01 Actavis Group Hf. IS
Impugan SE/H/1341/003 IS/1/13/039/02 Actavis Group Hf. IS
Impugan 9106 9106 Actavis Group Hf. SE
Impugan SE/H/1341/001 10777 Actavis Group Hf. SE
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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
Impugan SE/H/1341/002 14915 Actavis Group Hf. SE
Impugan SE/H/1341/003 8671 Actavis Group Hf. SE
Jufurix 39274.00.00 Juta Pharma Gmbh DE
Lasilix NL 14773 Sanofi Aventis France FR
Lasilix V 02105 Sanofi Aventis France FR
Lasilix V 02102 Sanofi Aventis France FR
Lasilix NL 11028 Sanofi Aventis France FR
Lasilix NL 11717 Sanofi Aventis France FR
Lasilix VNL 09028 Sanofi Aventis France FR
Lasilix VNL 09029 Sanofi Aventis France FR
Lasilix 082/01402 Sanofi Malta Ltd MT
Lasix 12.584 Sanofi-Aventis Gmbh Osterreich AT
Lasix 12.585 Sanofi-Aventis Gmbh Osterreich AT
Lasix 15.860 Sanofi-Aventis Gmbh Osterreich AT
Lasix 15.861 Sanofi-Aventis Gmbh Osterreich AT
Lasix 17.821 Sanofi-Aventis Gmbh Osterreich AT
Lasix 17.822 Sanofi-Aventis Gmbh Osterreich AT
Lasix BE067401 Sanofi Belgium BE
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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
Lasix BE067663 Sanofi Belgium BE
Lasix BE091497 Sanofi Belgium BE
Lasix BE091506 Sanofi Belgium BE
Lasix BE115367 Sanofi Belgium BE
Lasix 19672 Sanofi-Aventis Cyprus Ltd CY
Lasix 19673 Sanofi-Aventis Cyprus Ltd CY
Lasix 12043.00.00 Sanofi-Aventis Deutschland Gmbh DE
Lasix 22343.00.00 Sanofi-Aventis Deutschland Gmbh DE
Lasix 35018.00.00 Sanofi-Aventis Deutschland Gmbh DE
Lasix 6132084.00.00 Sanofi-Aventis Deutschland Gmbh DE
Lasix 6132115.00.00 Sanofi-Aventis Deutschland Gmbh DE
Lasix 6132196.00.00 Sanofi-Aventis Deutschland Gmbh DE
Lasix 6132227.00.00 Sanofi-Aventis Deutschland Gmbh DE
Lasix 09939 Sanofi-Aventis Denmark A/S DK
Lasix 09940 Sanofi-Aventis Denmark A/S DK
Lasix 9635 Sanofi Oy FI
Lasix 9636 Sanofi Oy FI
Lasix 15380/24-05-1989 Sanofi-Aventis Aebe GR
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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
Lasix 15542/25-05-89 Sanofi-Aventis Aebe GR
Lasix UP/I-530-09/12-01/681 Sanofi-Aventis Croatia D.O.O. HR
Lasix PA 540/52/2 Sanofi-Aventis Ireland Ltd IE
Lasix PA 540/52/5 Sanofi-Aventis Ireland Ltd IE
Lasix PA 540/52/4 Sanofi-Aventis Ireland Ltd IE
Lasix 920254 IS Sanofi-Aventis Norge As IS
Lasix 920255 IS Sanofi-Aventis Norge As IS
Lasix 020465011 Sanofi Spa IT
Lasix 023993013 Sanofi Spa IT
Lasix 023993049 Sanofi Spa IT
Lasix 023993052 Sanofi Spa IT
Lasix LT/1/99/1059/001 Uab Sanofi-Aventis Lietuva LT
Lasix LT/1/99/1059/002 Uab Sanofi-Aventis Lietuva LT
Lasix 2006/06058563 Sanofi Belgium LU
Lasix 2006/06058564 Sanofi Belgium LU
Lasix 02006/06058565 Sanofi Belgium LU
Lasix 02006/06058566 Sanofi Belgium LU
Lasix 02006/06058567 Sanofi Belgium LU
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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
Lasix RVG 07505 Sanofi-Aventis Netherlands B.V. NL
Lasix RVG 10129 Sanofi-Aventis Netherlands B.V. NL
Lasix RVG 15018 Sanofi-Aventis Netherlands B.V. NL
Lasix 6895 Sanofi-Aventis Norge As NO
Lasix 6896 Sanofi-Aventis Norge As NO
Lasix 4597282 Sanofi - Produtos Farmaceuticos Lda PT
Lasix 4597381 Sanofi - Produtos Farmaceuticos Lda PT
Lasix 5829890 Sanofi - Produtos Farmaceuticos Lda PT
Lasix 8113704 Sanofi - Produtos Farmaceuticos Lda PT
Lasix 8113837 Sanofi - Produtos Farmaceuticos Lda PT
Lasix 8113845 Sanofi - Produtos Farmaceuticos Lda PT
Lasix 9485102 Sanofi - Produtos Farmaceuticos Lda PT
Lasix 9803 Sanofi Ab SE
Lasix 9804 Sanofi Ab SE
Lasix 5363-I-180/11 Sanofi-Aventis D.O.O. SI
Lasix Retard 1-22210 Sanofi-Aventis Gmbh Osterreich AT
Lasix Retard 17.113 Sanofi-Aventis Gmbh Osterreich AT
Lasix Retard 327200 Sanofi-Aventis Estonia Oü EE
List of nationally authorised medicinal products EMA/729829/2015 Page 26/26
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
Riomid 40964/19-6-2008 Medicus A.E GR
Riomid 40965/19-6-2008 Medicus A.E GR
Salurex 20027 Remedica Ltd CY
Salurex 7733 Remedica Ltd CY
Salurex AA084/05301 Remedica Ltd MT
Seguril 39968 Sanofi-Aventis Sa ES
Seguril 39969 Sanofi-Aventis Sa ES
Seguril 56508 Sanofi-Aventis Sa ES
Vesix 07988 Takeda Oy FI
Vesix Special 07989 Takeda Oy FI
