14 September 2016 EMA/731767/2016 Procedure Management and Committees Support

List of nationally authorised medicinal products

Active substance: testosterone undecanoate (injection)

Procedure no.: PSUSA/00010161/201512

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) Nebid

MRP/DCP Authorisation number FI/H/0313/001

Nebid

FI/H/0313/001

Nebido

National Authorisation Number 037051012

MAH of product in the member state Bayer Spa

Member State where product is authorised Italy

037051024

Bayer Spa

Italy

7615/2015/01-02

Bayer Pharma Ag

Romania

Nebido

FI/H/0313/001

05-0141

Bayer Pharma Ag

Latvia

Nebido

FI/H/0313/001

1-25516

Bayer Austria Gmbh

Austria

Nebido

FI/H/0313/001

11740

Bayer Pharma Ag

Poland

Nebido

FI/H/0313/001

19681

Bayer Hellas Sa

Cyprus

Nebido

FI/H/0313/001

2007060006

Bayer Sa Nv

Luxembourg

Nebido

FI/H/0313/001

2007060006

Bayer Sa Nv

Luxembourg

Nebido

FI/H/0313/001

Bayer Portugal Sa

Portugal

Nebido

FI/H/0313/001

5159587 $ 5490057 56/0144/05-S

Bayer Pharma Ag

Slovakia

Nebido

FI/H/0313/001

5917/26-1-2011

Bayer Hellas Sa

Greece

Nebido

FI/H/0313/001

Bayer Sa Nv

Belgium

Nebido

FI/H/0313/001

BE266384 $ BE437132 BE437132

Bayer Sa Nv

Belgium

Nebido

FI/H/0313/001

Bayer Pharma Ag

Slovenia

Nebido

FI/H/0313/001

Bayer Pharma Ag

Lithuania

Nebido

FI/H/0313/001

H/05/01097/001 $ H/05/01097/002 LT/1/05/0222/001 $ LT/1/05/0222/002 MA185/02701

Bayer Plc

Malta

Nebido

FI/H/0313/001

PL 00010/0549

Bayer Plc

United Kingdom

Nebido

FI/H/0313/001

RVG 30794

Bayer Bv

Netherlands

Nebido

FI/H/313/01

04- 2635

Bayer Pharma Ag

Norway

Nebido

FI/H/313/01

17857

Bayer Oy

Finland

Nebido

FI/H/313/01

20890

Bayer Pharma Ag

Sweden

Nebido

FI/H/313/01

NL30240

Bayer Healthcare

France

Nebido

FI/H/313/01

36481

Bayer Pharma Ag

Denmark

List of nationally authorised medicinal products EMA/731767/2016

Page 2/3

Nebido

FI/H/313/01

472505

Bayer Pharma Ag

Estonia

Nebido

FI/H/313/01

56/176/05-C

Bayer Pharma Ag

Czech Republic

Nebido

FI/H/313/01

60074.00.00

Jenapharm Gmbh & Co Kg

Germany

Nebido

FI/H/313/01

Bayer Doo

Croatia

Nebido

FI/H/313/01

HR-H-72866688801 $ HR-H728666888-02 IS/1/04/026/01

Bayer Pharma Ag

Iceland

Nebido

FI/H/313/01

Bayer Pharma Ag

Hungary

Nebido

FI/H/313/01

OGYI-T-10175/01 $ OGYI-T-10175/02 PA 1410/20/1

Bayer Ltd

Ireland

Reandron

FI/H/313/01

66.470

Bayer Hispania Sl

Spain

II14422/12.08.2011

Bayer Pharma Ag

Bulgaria

небидо

List of nationally authorised medicinal products EMA/731767/2015

Page 3/3

Testosterone undecanoate - European Medicines Agency - Europa EU

Sep 14, 2016 - 30 Churchill Place ○ Canary Wharf ○ London E14 5EU ○ United Kingdom ... Procedure Management and Committees Support. List of ...

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