L ist of nationally authorised medicinal products · 12 November 2020 . EMA/698316/2020 . Human...

Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands

An agency of the European Union Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000

© European Medicines Agency, 2020. Reproduction is authorised provided the source is acknowledged.

12 November 2020 EMA/698316/2020 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance: Fluconazole PSUSA/00001404/202003

Procedure no.: PSUSA/00001404/202003

List of nationally authorised medicinal products EMA/698316/2020 Page 2/68

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

ELAZOR 200 mg capsule rigide

not available 027268097 ALFASIGMA S.P.A. IT







Fluconazol PUREN 150 mg Hartkapseln

not available 96846.00.00 PUREN PHARMA GMBH & CO. KG

DE

Fluconazol Accord 150 mg Hartkapseln

SE/H/1063/003 84492.00.00 ACCORD HEALTHCARE B.V. DE

Fluconazol Kern Pharma 150 mg cápsulas duras

not available 59.059 KERN PHARMA, S.L. ES

Fluconazole 50mg Capsules

not available PL 21880/0134 MEDREICH PLC UK










Diflucan 200 mg cápsulas DE/H/3456/004 2074680 LABORATÓRIOS PFIZER, LDA. PT

Diflucan 10 mg/ml Pulver zur Herstellung einer Suspension zum Einnehmen

DE/H/3456/005 BE160422 PFIZER S.A. (BELGIUM) BE

Diflucan 100 mg Hartkapseln


Diflucan 10 mg/ml Pulver zur Herstellung einer Suspension zum Einnehmen

DE/H/3456/005 2003097827 PFIZER S.A. (BELGIUM) LU

Diflucan 2 mg/ml Infusionslösung


Diflucan 2 mg/ml solution pour perfusion


Diflucan 2 mg/ml Infusionslösung








Diflucan 2 mg/ml oplossing voor infusie


Diflucan 100 mg Hartkapseln


Diflucan 2 mg/ml infuusioneste, liuos

DE/H/3456/006 10021 PFIZER OY FI

Diflucan, infusionsvæske, opløsning

DE/H/3456/006 13397 PFIZER APS DK



Diflucan 150 mg, kõvakapslid

DE/H/3456/003 104595 PFIZER EUROPE MA EEIG EE

Diflucan, kapsler, hårde DE/H/3456/001 13091 PFIZER APS DK

Diflucan, pulver til oral suspension









Diflucan 100 mg tvrdé tobolky

DE/H/3456/002 26/121/91 – B/C PFIZER, SPOL. S R.O. CZ


DE/H/3456/001 26/121/91 – A/C PFIZER, SPOL. S R.O. CZ

Diflucan 50 mg kovat kapselit








Diflucan 40 mg/ml poudre pour suspension buvable


Diflucan 40 mg/ml jauhe oraalisuspensiota varten








DE/H/3456/003 26/121/91 – C/C PFIZER, SPOL. S R.O. CZ

Diflucan 2 mg/ml innrennslislyf, lausn

DE/H/3456/006 890097 PFIZER APS IS







TRIFLUCAN 50 mg/5 ml, poudre pour suspension buvable

DE/H/3456/005 34009 335 470 9 7 PFIZER HOLDING FRANCE FR

Fungustatin 2 mg/ml διάλυμα για έγχυση

DE/H/3456/006 13275 PFIZER HELLAS, A.E. CY










Fungustatin 40 mg/ml κόνις για πόσιμο εναιώρημα

DE/H/3456/008 41150/10/31-05-2011 PFIZER HELLAS, A.E. GR



Fungustatin 10 mg/ml κόνις για πόσιμο εναιώρημα


Fungustatin 150 mg σκληρά καψάκια



DE/H/3456/006 71799/30-9-2016 PFIZER HELLAS, A.E. GR




















Diflucan 200 mg hard capsules

DE/H/3456/004 PL 00057/0317 PFIZER LIMITED UK



Diflucan 40 mg/ml powder for oral suspension


Diflucan 2 mg/ml solution for infusion











Diflucan 150 mg capsule DE/H/3456/003 5125/2012/19 PFIZER EUROPE MA EEIG RO




















Diflucan 100 mg cápsulas duras.

DE/H/3456/002 58.804 VINCIFARMA S.A. ES










Diflucan 10 mg/ml polvo para suspensión oral







Diflucan 40 mg/ml polvo para suspensión oral








DE/H/3456/001 PA 0822/211/001 PFIZER HEALTHCARE IRELAND

IE

DIFLUCAN 50 mg kietosios kapsulės

DE/H/3456/001 LT/1/96/1923/007 PFIZER EUROPE MA EEIG LT






























Дифлукан 150 mg твърди капсули

DE/H/3456/003 20010472 PFIZER EUROPE MA EEIG BG


















Дифлукан 2 mg/ml инфузионен разтвор



















Diflucan 150 mg kemény kapszula

DE/H/3456/003 OGYI-T-1550/05 PFIZER KFT. HU






















Diflucan 50 mg trde kapsule

DE/H/3456/001 H/93/00473/008 PFIZER LUXEMBOURG SARL SI


































Diflucan 50 mg gélules DE/H/3456/001 2003097823 PFIZER S.A. (BELGIUM) LU








Diflucan 200 mg harde capsules















Diflucan 2 mg/ml oplossing voor infusie















TRIFLUCAN 2 mg/ml, solution pour perfusion


Diflucan 200 mg kapsel, hard

DE/H/3456/004 7601 PFIZER AS NO

Diflucan 2 mg/ml infusjonsvæske, oppløsning




TRIFLUCAN 100 mg, gélule







TRIFLUCAN 40 mg/ml, poudre pour suspension buvable










TRIFLUCAN 10 mg/ml, poudre pour suspension buvable




FLUCONAZOLE PFIZER 150 mg, gélule


TRIFLUCAN 50 mg, gélule DE/H/3456/001 34009 556 136 4 0 PFIZER HOLDING FRANCE FR








Diflucan 10 mg/ml pó para suspensão oral

DE/H/3456/005 2132181 LABORATÓRIOS PFIZER, LDA. PT



















Diflucan 40 mg/ml prašek za peroralno suspenzijo




















Diflucan 40 mg/ml poudre pour suspension buvable





















Diflucan, 2 mg/ml, roztwór do infuzji

DE/H/3456/006 R/0717 PFIZER EUROPE MA EEIG PL

Diflucan 2 mg/ml soluţie perfuzabilă

DE/H/3456/006 6166/2014/03 PFIZER EUROPE MA EEIG RO









Diflucan 10 mg/ml pulbere pentru suspensie orală























Diflucan 40 mg/ml prašek za peroralno suspenzijo


Diflucan 40 mg/ml pó para suspensão oral

DE/H/3456/008 2132280 LABORATÓRIOS PFIZER, LDA. PT















IE



IE

Diflucan 40 mg/ml, poeder voor orale suspensie

DE/H/3456/008 RVG 15758 PFIZER B.V. NL

Diflucan 40 mg/ml pulver til mikstur, suspensjon

DE/H/3456/008 00-7659 PFIZER AS NO



IE

Diflucan 50 mg, capsule, hard









Diflucan I.V. 2 mg/ml, oplossing voor infusie




IE







Diflucan 10 mg/ml pulver til mikstur, suspensjon

DE/H/3456/005 00-7658 PFIZER AS NO





IE








IE

Diflucan 10 mg/ml, poeder voor orale suspensie




IE

Diflucan® 2 mg/ml Infusionslösung

DE/H/3456/006 1-18900 PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H.

AT



AT



AT



AT

Diflucan® 100 mg – Kapseln


AT

Diflucan® 10 mg/ml Trockensaft


AT






Diflucan 150 mg capsule rigide

DE/H/3456/003 027267626 PFIZER ITALIA S.R.L. IT







Diflucan 2 mg/ml soluzione per infusione



















Diflucan® 40 mg/ml Trockensaft


AT


















Diflucan 10 mg/ml polvere per sospensione orale



































Diflucan 10 mg/ml por belsőleges szuszpenzióhoz


Diflucan 40 mg/ml por belsőleges szuszpenzióhoz













AT



AT



AT

Diflucan® i.v. 2 mg/ml Infusionslösung

DE/H/3456/006 18943.01.02 PFIZER PHARMA PFE GMBH DE



Diflucan hörð hylki DE/H/3456/004 990116 PFIZER APS IS

Diflucan® Saft 50 mg/10 ml Lösung zum Einnehmen


Diflucan® 100 mg Hartkapseln







Diflucan® Trockensaft 10 mg/ml Pulver zur Herstellung einer Suspension zum Einnehmen


Diflucan® 40 mg/ml Pulver zur Herstellung einer Suspension zum Einnehmen





Fungata® DE/H/3456/003 15824.00.00 PFIZER PHARMA PFE GMBH DE











Diflucan 10 mg/ml mixtúruduft, lausn.


Diflucan 150 mg hårda kapslar

DE/H/3456/003 10898 PFIZER AB SE







Diflucan 40 mg/ml pulver till oral suspension


Diflucan 150 mg cietās kapsulas

DE/H/3456/003 02-0251 PFIZER EUROPE MA EEIG LV

Diflucan 10 mg/ml pulver till oral suspension


Diflucan 10 mg/ml polvere per sospensione orale







DIFLUCAN 150 mg tvrdé kapsuly

DE/H/3456/003 26/0111/12–S PFIZER EUROPE MA EEIG SK

DIFLUCAN P.O.S. 10 mg/ml prášok na perorálnu suspenziu

DE/H/3456/005 26/0256/96-S PFIZER EUROPE MA EEIG SK

DIFLUCAN P.O.S. 40 mg/ml prášok na perorálnu suspenziu

DE/H/3456/008 26/0142/12-S PFIZER EUROPE MA EEIG SK


DE/H/3456/002 26/0110/12–S PFIZER EUROPE MA EEIG SK


DE/H/3456/001 26/0121/91–C/S PFIZER EUROPE MA EEIG SK





















Tesco Health Thrush Relief 150mg Capsule

not available PL 20395/0042 RELON CHEM LIMITED UK



Bells Healthcare Thrush Relief Oral 150mg Capsule




Canesten Thrush Duo Oral Capsule & External Cream 150mg / 2% w/w capsule & cream

not available PL 00010/0652 BAYER PLC UK












FLUCONAZOLE PFIZER 50 mg/5 ml, poudre pour suspension buvable


Fungata® 150 mg – Kapsel


AT

Diflucan® Derm Saft 50 mg/10 ml Lösung zum Einnehmen


Fluconazol Pfizer 150 mg Hartkapseln




Fluconazol Pfizer 10 mg/ml Pulver zur Herstellung einer Suspension zum Einnehmen









Diflucan® Derm 50 mg Hartkapseln


FLUCONAZOLE PFIZER 10 mg/ml, poudre pour suspension buvable










Fluconazole 100 mg capsules, hard

PT/H/1954/002 PL 16363/0316 MILPHARM LIMITED UK

Fluconazol Aurobindo 150 mg Hartkapseln

PT/H/1954/003 72224.00.00 AUROBINDO PHARMA GMBH DE






Fluconazol Aurobindo 100 mg capsule

PT/H/1954/002 10618/2018/01 AUROBINDO PHARMA ROMÂNIA S.R.L.

RO



RO



RO



RO



RO



RO



RO



RO



RO








RO



RO



RO



RO



RO



RO



RO



RO



RO








RO

Fluconazole 50 mg Capsules

not available PL 36722/0120 SPECIAL CONCEPT DEVELOPMENT (UK) LTD

UK



UK



UK



UK

Fluconazol Kern Pharma 150 mg cápsulas duras

not available 59.059 KERN PHARMA, S.L. ES














Fluconazol B. Braun 2 mg/ml Infusionslösung

DE/H/1055/001 1-28430 B.BRAUN MELSUNGEN AG AT

Fluconazol B. Braun 2 mg/ml Infusionsl ﾃｶ sung

DE/H/1055/001 69716.00.00 B.BRAUN MELSUNGEN AG DE



UK



UK



UK



UK

Careway Thrush Relief 150mg Hard Capsules

not available 29831/0318 WOCKHARDT UK LTD UK

Lloyds Pharmacy Single Dose Thrush Relief 150mg Hard Capsules







Fluconazole 150mg Hard Capsules






Diflucan 150 mg tvrde kapsule

not available HR-H-744744897 PFIZER CROATIA D.O.O. HR





Diflucan 10 mg/ml prašak za oralnu suspenziju


MYCAZOLE not available 27544/14 VERISFIELD (UK) LTD GR

MYCAZOLE not available 27545/14 VERISFIELD (UK) LTD GR






MYCAZOLE 200 mg κόνις για πόσιμο διάλυμα

not available 27546/14 VERISFIELD (UK) LTD GR

Fluconazol "Hexal" DK/H/0440/002 32818 HEXAL A/S DK

L ist of nationally authorised medicinal products · 12 November 2020 . EMA/698316/2020 . Human...

Documents

Transcript of L ist of nationally authorised medicinal products · 12 November 2020 . EMA/698316/2020 . Human...