20 April 2017 EMA/344631/2017 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance(s): finasteride
Procedure No.: PSUSA/00001392/201608
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5525 Send a question via our website www.ema.europa.eu/contact
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© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation
MAH of product in the member state
CHIBRO-PROSCAR 5 mg, comprimé pelliculé CHIBRO-PROSCAR 5 mg, comprimé pelliculé CHIBRO-PROSCAR 5 mg, comprimé pelliculé CHIBRO-PROSCAR 5 mg, comprimé pelliculé CHIBRO-PROSCAR 5 mg, comprimé pelliculé CHIBRO-PROSCAR 5 mg, comprimé pelliculé CHIBRO-PROSCAR 5 mg, comprimé pelliculé CHIBRO-PROSCAR 5 mg, comprimé pelliculé Finasteride 1 mg Film-coated Tablets FINASTERIDE 5 mg Film-coated tablets
not available
34009 335 248 4 5
MSD FRANCE
Member State where product is authorised FR
not available
34009 379 090 7 5
MSD FRANCE
FR
not available
34009 379 091 3 6
MSD FRANCE
FR
not available
34009 335 688 4 9
MSD FRANCE
FR
not available
34009 335 249 0 6
MSD FRANCE
FR
not available
34009 335 690 9 9
MSD FRANCE
FR
not available
34009 335 689 0 0
MSD FRANCE
FR
not available
34009 335 691 5 0
MSD FRANCE
FR
UK/H/4251/001 not available
PL 00289/0826 PA 1286/44/1
UK IE
Finasteride 5 mg film-coated tablets Finasteride 5 mg Tablets Finasteride AHCL 1 mg compresse rivestite con film FINASTID 5 mg compresse rivestite con film FINASTID 5 mg compresse rivestite con film GENAPROST 5 mg compresse rivestite con film GENAPROST 5 mg compresse rivestite con film PILUS 1 mg compressa rivestita con film PILUS 1 mg compressa rivestita con film PILUS 1 mg compressa rivestita con film
not available AT/H/0268/001 NL/H/1149/001
PL 21880/0052 PL 04416/0816 039595196
not available
028309019
not available
028309021
not available
028371019
not available
028371021
not available
034824019
not available
034824033
not available
034824045
TEVA UK LIMITED MERCK SHARP & DOHME IRELAND (HUMAN HEALTH) LTD MEDREICH PLC SANDOZ LTD ACCORD HEALTHCARE LIMITED NEOPHARMED GENTILI S.R.L. NEOPHARMED GENTILI S.R.L. NEOPHARMED GENTILI S.R.L. NEOPHARMED GENTILI S.R.L. NEOPHARMED GENTILI S.R.L. NEOPHARMED GENTILI S.R.L. NEOPHARMED GENTILI S.R.L.
List of nationally authorised medicinal products EMA/344631/2017
UK UK IT IT IT IT IT IT IT IT
Page 2/6
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation
MAH of product in the member state
PILUS 1 mg compressa rivestita con film PILUS 1 mg compressa rivestita con film PROPECIA 1 mg compresse rivestite con film PROPECIA 1 mg compresse rivestite con film PROPECIA 1 mg compresse rivestite con film PROPECIA 1 mg compresse rivestite con film PROPECIA 1 mg compresse rivestite con film PROPECIA 1 mg comprimate filmate
not available
034824058
not available
034824021
SE/H/0158/001
034237014
NEOPHARMED GENTILI S.R.L. NEOPHARMED GENTILI S.R.L. MSD ITALIA S.R.L.
SE/H/0158/001
034237038
MSD ITALIA S.R.L.
IT
SE/H/0158/001
034237040
MSD ITALIA S.R.L.
IT
SE/H/0158/001
034237053
MSD ITALIA S.R.L.
IT
SE/H/0158/001
034237026
MSD ITALIA S.R.L.
IT
not available
5198/2005/01
& DOHME
RO
PROPECIA 1 mg comprimate filmate
not available
5198/2005/01
& DOHME
RO
Propecia 1 mg comprimidos recubiertos con película PROPECIA 1 mg comprimidos revestidos por película PROPECIA 1 mg comprimidos revestidos por película PROPECIA 1 mg comprimidos revestidos por película PROPECIA 1 mg comprimidos revestidos por película PROPECIA 1 mg comprimidos revestidos por película PROPECIA 1 mg Film-Coated Tablets
SE/H/0158/001
62.441
& DOHME DE
ES
SE/H/0158/001
2832988
& DOHME,
PT
SE/H/0158/001
2832780
& DOHME,
PT
SE/H/0158/001
2832889
& DOHME,
PT
SE/H/0158/001
2832582
& DOHME,
PT
SE/H/0158/001
2832681
& DOHME,
PT
not available
MA058/00801
& DOHME
MT
PROPECIA 1 mg Film-Coated Tablets
not available
MA058/00801
& DOHME
MT
PROPECIA 1 mg filmdragerad tablett Propecia 1 mg filmdragerade tabletter
SE/H/0158/001 SE/H/0158/001
13483 13713
MERCK SHARP ROMANIA SRL MERCK SHARP ROMANIA SRL MERCK SHARP ESPAÑA, S.A MERCK SHARP LDA. MERCK SHARP LDA. MERCK SHARP LDA. MERCK SHARP LDA. MERCK SHARP LDA. MERCK SHARP LTD. MERCK SHARP LTD. MERCK SHARP MERCK SHARP
& DOHME BV & DOHME BV
SE FI
List of nationally authorised medicinal products EMA/382341/2015
Member State where product is authorised IT IT IT
Page 3/6
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation
MAH of product in the member state
PROPECIA 1 mg filmomhulde tabletten Propecia 1 mg filmsko obložene tablete
SE/H/0158/001 not available
RVG 27397 H/99/01294/001
Propecia 1 mg filmsko obložene tablete
not available
H/99/01294/001
Propecia 1 mg Filmtabletten
SE/H/0158/001
1-24532
Propecia 1 mg filmuhúðaðar töflur Propecia 1 mg tabletti, kalvopäällysteinen PROPECIA 1 mg, comprimé pelliculé PROPECIA 1 mg, comprimé pelliculé PROPECIA 1 mg, comprimé pelliculé PROPECIA 1 mg, comprimé pelliculé PROPECIA 1 mg, comprimé pelliculé PROPECIA 1 mg, film-coated tablets PROPECIA 1 mg, film-coated tablets PROPECIA 1 mg, tabletki powlekane PROPECIA 1 mg, tabletki powlekane PROPECIA 1mg, επικαλυμμένα με λεπτό υμένιο δισκία Propecia, filmovertrukne tabletter PROPECIA® 1 mg Film-Coated Tablets
SE/H/0158/001 SE/H/0158/001
IS/1/02/010/01 13713
MERCK SHARP & DOHME BV MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O. MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O. MERCK SHARP & DOHME GES.M.B.H. MERCK SHARP & DOHME BV MERCK SHARP & DOHME BV
SE/H/0158/001 SE/H/0158/001 SE/H/0158/001 SE/H/0158/001 SE/H/0158/001 not available not available not available not available SE/H/158/01/R02
34009 349 065 4 1 34009 349 070 8 1 34009 349 066 0 2 34009 349 068 3 1 34009 349 067 7 0 18318 18318 4602 4602 52369/30-06-2016
MSD FRANCE MSD FRANCE MSD FRANCE MSD FRANCE MSD FRANCE MERCK SHARP & DOHME BV MERCK SHARP & DOHME BV MSD POLSKA SP. Z O.O. MSD POLSKA SP. Z O.O. VIANEX S.A.
FR FR FR FR FR CY CY PL PL GR
SE/H/0158/001 not available
30252 PL 0025/0351
DK UK
PROPECIA® 1 mg Film-Coated Tablets
not available
PL 0025/0351
PROPECIA® 1 mg Filmtabletten
SE/H/0158/001
44270.00.00
PROPECIA® 1 mg, comprimé pelliculé PROPECIA® potahované tablety PROPECIA® potahované tablety PROSCAR 5 mg compresse rivestite con film
SE/H/0158/001 not available not available not available
2009030231 87/244/99-C 87/244/99-C 028308017
MERCK SHARP & DOHME BV MERCK SHARP & DOHME LTD. MERCK SHARP & DOHME LTD. MSD SHARP & DOHME GMBH MSD BELGIUM BVBA/SPRL MERCK SHARP & DOHME BV MERCK SHARP & DOHME BV MERCK SHARP & DOHME LTD.
List of nationally authorised medicinal products EMA/382341/2015
Member State where product is authorised NL SI SI AT IS FI
UK DE LU CZ CZ IT
Page 4/6
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation
MAH of product in the member state
PROSCAR 5 mg compresse rivestite con film PROSCAR 5 mg comprimate filmate
not available
028308029
not available
5885/2013/01
PROSCAR 5 mg comprimate filmate
not available
5885/2013/02
PROSCAR 5 mg comprimidos recubiertos con película PROSCAR 5 mg comprimidos revestidos por película PROSCAR 5 mg comprimidos revestidos por película PROSCAR 5 mg comprimidos revestidos por película PROSCAR 5 mg comprimidos revestidos por película PROSCAR 5 mg comprimidos revestidos por película PROSCAR 5 mg comprimidos revestidos por película Proscar 5 mg filmdragerad tablett Proscar 5 mg filmdragerade tabletter Proscar 5 mg Filmtabletten
not available
59.830
not available
2133189
not available
2133288
not available
2133387
not available
2133189
not available
2133288
not available
2133387
not available not available not available
11644 10751 1-19689
Proscar 5 mg tabletter PROSCAR 5 mg tabletti, kalvopäällysteinen PROSCAR 5 mg, filmomhulde tabletten PROSCAR επικαλυμμένο με λεπτό υμένιο δισκίο 5 mg/TAB PROSCAR, 5 mg, film-coated tablets PROSCAR, 5 mg, tabletki powlekane Proscar, filmovertrukne tabletter PROSCAR® 5 mg filmom obložene tablete
not available not available
7841 10751
MERCK SHARP & DOHME LTD. MERCK SHARP & DOHME ROMANIA SRL MERCK SHARP & DOHME ROMANIA SRL LABORATORIOS CHIBRET, S.A. MERCK SHARP & DOHME, LDA. MERCK SHARP & DOHME, LDA. MERCK SHARP & DOHME, LDA. MERCK SHARP & DOHME, LDA. MERCK SHARP & DOHME, LDA. MERCK SHARP & DOHME, LDA. MERCK SHARP & DOHME BV MERCK SHARP & DOHME BV MERCK SHARP & DOHME GES.M.B.H. MERCK SHARP & DOHME BV MERCK SHARP & DOHME BV
not available not available
RVG 15482 21729
MERCK SHARP & DOHME BV VIANEX S.A.
NL GR
not not not not
19539 R/3621 14514 HR-H-039526411
MERCK SHARP & DOHME BV MSD POLSKA SP. Z O.O. MERCK SHARP & DOHME BV MERCK SHARP & DOHME D.O.O.
CY PL DK HR
List of nationally authorised medicinal products EMA/382341/2015
available available available available
Member State where product is authorised IT RO RO ES PT PT PT PT PT PT SE FI AT NO FI
Page 5/6
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation
MAH of product in the member state
PROSCAR® 5 mg, comprimés pelliculés PROSCAR® 5 mg, comprimés pelliculés PROSCAR® 5 mg, filmomhulde tabletten PROSCAR® 5 mg, Filmtabletten PROSCAR® 5 mg film-coated Tablets (finasteride) PROSCAR® 5 mg film-coated Tablets (finasteride) PROSCAR° 5 mg Filmtabletten
not available
BE160124
MSD BELGIUM BVBA/SPRL
Member State where product is authorised BE
not available
2003107721
MSD BELGIUM BVBA/SPRL
LU
not available
BE160124
MSD BELGIUM BVBA/SPRL
BE
not available not available
BE160124 MA 058/00701
BE MT
not available
PL 0025/0279
not available
42859.00.00
PROSTIDE 5 mg compresse rivestite con film
not available
028356018
PROSTIDE 5 mg compresse rivestite con film
not available
028356020
Prostide 5 mg filmsko obložene tablete
not available
H/97/01301/001
Prostide 5 mg filmsko obložene tablete
not available
H/97/01301/001
MSD BELGIUM BVBA/SPRL MERCK SHARP & DOHME LTD. MERCK SHARP & DOHME LTD. MSD SHARP & DOHME GMBH SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE S.P.A. SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE S.P.A. MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O. MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
List of nationally authorised medicinal products EMA/382341/2015
UK DE IT IT SI SI
Page 6/6
