testosterone - European Medicines Agency - Europa EU

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