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testosterone - European Medicines Agency - Europa EU
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testosterone - European Medicines Agency - Europa EU
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Sep 14, 2016 - 30 Churchill Place â Canary Wharf â London E14 5EU â United Kingdom. An agency of ... Procedure Man
14 September 2016 EMA/730861/2016 Procedure Management and Committees Support
List of nationally authorised medicinal products
Active substance: testosterone (all formulations apart from topical use and testosterone undecanoate injection)
Procedure no.: PSUSA/00002907/201512
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
An agency of the European Union
© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.
Product Name (in authorisation country) Andriol Andriol
MRP/DCP Authorisation number
National Authorisation Number 024585010 $ 024585034 1-19756
MAH of product in the member state Msd Italia S.R.L.
Member State where product is authorised Italy
Nv Organon
Austria
Andriol
6598
Nv Organon
Norway
Andriol
9264
Nv Organon
Denmark
Andriol Testocaps
OGYI-T-9405/01 $ OGYI-T-9405/02 $ OGYI-T-9405/03 RVG 07531
Nv Organon
Hungary
Nv Organon
Netherlands
Merck Sharp & Dohme, Lda.
Portugal
Androtardyl
4147989 $ 4781183 $ 4781282 34 009 300 461 3 5
Bayer Healthcare
France
Panteston
7845
Nv Organon
Finland
Panteston
7845
Nv Organon
Finland
Pantestone
Msd France
France
Nv Organon
Greece
Restandol Testocaps
34009 377 647 4 2 $ 34009 377 648 0 3 $ 34009 379 817 43 41177/10/31-052011 PA 1286/54/1
Ireland
Restandol Testocaps
PL 00025/0595
Merck Sharp & Dohme Ireland (Human Health) Ltd Merck Sharp & Dohme Ltd.
Sustanon
016094017
Trading
Italy
Sustanon
211498
Trading
Estonia
Sustanon
3811
Trading
Finland
Sustanon
56/0357/91-C/S
Trading
Slovakia
Sustanon
97-0497
Aspen Pharma Limited Aspen Pharma Limited Aspen Pharma Limited Aspen Pharma Limited Aspen Pharma
Trading
Latvia
Andriol Testocaps Andriol-T
Restandol Testocaps
List of nationally authorised medicinal products EMA/730861/2016
United Kingdom
Page 2/4
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
Sustanon
BE 012704
Sustanon
LT/1/97/1261/003
Sustanon
PL 39699/0059
Sustanon '250'
BE 012704
Sustanon 250
56/357/91-C
Sustanon ‘250’
BE 012704
Sustenon
8890012
Testocaps
2007079379
Testocaps
BE 113793 $ BE113793 PL 16853/0116
MAH of product in the member state Limited Aspen Pharma Limited Aspen Pharma Limited Aspen Pharma Limited Aspen Pharma Limited Aspen Pharma Limited Aspen Pharma Limited Aspen Pharma Limited Nv Organon
Member State where product is authorised
Trading
Luxembourg
Trading
Lithuania
Trading
United Kingdom
Trading
Belgium
Trading
Czech Republic
Trading
Belgium
Trading
Portugal Luxembourg
Nv Organon
Belgium United Kingdom
002922060
Alliance Pharmaceuticals Ltd Bayer Spa
Testoviron Depot
8888222
Bayer Portugal Sa
Portugal
Testoviron-Depot
6929279.00.00
Jenapharm Gmbh & Co Kg
Germany
Testovis
003559059
Italy
Undestor
56/023/91-S/C
Laboratorio Farmaceutico S.I.T. S.R.L. Nv Organon
Undestor Testocaps
Nv Organon
Romania
Undestor Testocaps
1076/2008/01 $ 1076/2008/02 $ 1076/2008/03 56/0091/03-S
Nv Organon
Slovakia
Undestor Testocaps
9559
Merck Sharp & Dohme Bv
Sweden
Undestor Testocaps
R/2344
Nv Organon
Poland
Testosterone Enantate Alliance Pharmaceuticals Testoviron
List of nationally authorised medicinal products EMA/730861/2015
Italy
Czech Republic
Page 3/4
Product Name (in authorisation country) Virormone
List of nationally authorised medicinal products EMA/730861/2015
MRP/DCP Authorisation number
National Authorisation Number PL00111/0203
MAH of product in the member state Dhp Healthcare Ltd
Member State where product is authorised United Kingdom
Page 4/4
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