Testosterone undecanoate - European Medicines Agency - Europa EU

Recommend Documents

testosterone - European Medicines Agency - Europa EU

testosterone undecanoate (injection) - European Medicines Agency

human medicines - European Medicines Agency - Europa EU

Jul 1, 2015 - highlights newsletter' and then click on 'Subscribe to this feed'. .... granted a conditional marketing au

human medicines - European Medicines Agency - Europa EU

Jul 1, 2015 - highlights newsletter' and then click on 'Subscribe to this feed'. .... granted a conditional marketing au

Agenda - European Medicines Agency - Europa EU

Sep 20, 2016 - I. Moulon (EMA). 08:50. 1.1 HCPWP co-chair election proceedings. 1.2 Nomination of observers to the PCWP.

AESGP - European Medicines Agency - Europa EU

Agenda - European Medicines Agency - Europa EU

Evofosfamide - European Medicines Agency - Europa EU

Notification of discontinuation of a paediatric development which is covered by an agreed ... for the following reason(s

ICSR - European Medicines Agency - Europa EU

Jul 6, 2017 - (ICSRs) and is applicable to all stakeholders, which are exchanging ICSRs electronically within the .....

Minutes - European Medicines Agency - Europa EU

Aug 17, 2016 - Pr Bobby Gaspar; Severe combined immunodeficiency disorder due to ..... necessary before any application

Survey report - European Medicines Agency - Europa EU

Oct 20, 2016 - identifies key priorities which will need to be implemented in the coming years to 2020. .... European Me

Agenda - European Medicines Agency - Europa EU

Nov 3, 2015 - the Scientific Committee Secretariat at the start of meeting. ..... the resulting impacts on food safety)

Agenda - European Medicines Agency - Europa EU

Nov 28, 2016 - 15 December 2016, Time 09:00-12:00, room 7/B, via Adobe Connect ... and may also change during the course

Onglyza - European Medicines Agency - Europa EU

Jul 1, 2008 - Overall conclusions, risk/benefit assessment and recommendation . ..... were performed with the drug subst

Agenda - European Medicines Agency - Europa EU

Dec 14, 2015 - Draft agenda for the meeting on 14-17 December 2015 ...... Final agenda of WP meeting held by teleconfere

Agenda - European Medicines Agency - Europa EU

Minutes - European Medicines Agency - Europa EU

Aug 12, 2015 - Bayer Pharma AG; Treatment of mesothelioma/ Treatment of ... advanced or metastatic, mesothelin-overexpre

Remsima : EPAR - European Medicines Agency - Europa EU

This is a summary of the European public assessment report (EPAR) for Remsima. ... used with methotrexate (a medicine th

Aldara - European Medicines Agency - Europa EU

Aldara cream has no or negligible influence on the ability to drive and use machines ..... These trials failed to demons

Agenda - European Medicines Agency - Europa EU

Sep 12, 2016 - Some of the information contained in this agenda is considered commercially confidential or sensitive and

Assessment Report - European Medicines Agency - Europa EU

May 22, 2014 - weight was found to be superior to using body surface area (BSA) effect ... The population median BSA of

Agenda - European Medicines Agency - Europa EU

Sep 8, 2014 - 17 September 2014, 10:00-12:00, room 5/D, via teleconference. Health and Safety Information. In accordance

everolimus - European Medicines Agency - Europa EU

Mar 31, 2016 - Procedure Management and Committees Support. List of nationally ...... LIMITED (ART57). UK. Certican 0.25

Stem cell - European Medicines Agency - Europa EU

Jul 14, 2016 - Stem cell-based products for veterinary use: specific ... potentially delay time to rejection providing a

Testosterone undecanoate - European Medicines Agency - Europa EU

Download PDF

102 downloads 322 Views 86KB Size Report

Comment

Sep 14, 2016 - 30 Churchill Place â Canary Wharf â London E14 5EU â United Kingdom ... Procedure Management and Co

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