1 September 2017 EMA/590501/2017 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance(s): testosterone undecanoate (injection)

Procedure No.: PSUSA/00010161/201612

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© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.

Product name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Nebid 1000 mg/4ml, soluzione iniettabile. Nebid 1000 mg/4ml, soluzione iniettabile. Nebido 1000 mg /4 ml stungulyf, lausn Nebido 1000 mg/ 4 ml, injekční roztok Nebido 1000 mg/4 ml injekcinis tirpalas Nebido 1000 mg/4 ml injekcinis tirpalas Nebido 1000 mg/4 ml injekčný roztok Nebido 1000 mg/4 ml injeksjonsvæske, oppløsning Nebido 1000 mg/4 ml injektioneste, liuos Nebido 1000 mg/4 ml Injektionslösung Nebido 1000 mg/4 ml Injektionslösung Nebido 1000 mg/4 ml Injektionslösung Nebido 1000 mg/4 ml Injektionslösung Nebido 1000 mg/4 ml injektionsvätska, lösning Nebido 1000 mg/4 ml injektionsvätska, lösning Nebido 1000 mg/4 ml oplossing voor injectie Nebido 1000 mg/4 ml oplossing voor injectie Nebido 1000 mg/4 ml otopina za injekciju

FI/H/0313/001

037051012

BAYER SPA

IT

FI/H/0313/001

037051024

BAYER SPA

IT

FI/H/0313/001

IS/1/04/026/01

BAYER PHARMA AG

IS

FI/H/313/01

56/176/05-C

BAYER PHARMA AG

CZ

FI/H/0313/001

LT/1/05/0222/001

BAYER PHARMA AG

LT

FI/H/0313/001

LT/1/05/0222/002

BAYER PHARMA AG

LT

FI/H/0313/001

56/0144/05-S

BAYER PHARMA AG

SK

FI/H/0313/001

04- 2635

BAYER PHARMA AG

NO

FI/H/0313/001

17857

BAYER OY

FI

FI/H/0313/001

1-25516

BAYER AUSTRIA GMBH

AT

FI/H/313/01

BE266384

BAYER SA NV

BE

FI/H/0313/001

BE437132

BAYER SA NV

BE

FI/H/313/01

2007060006

BAYER SA NV

LU

FI/H/0313/001

17857

BAYER OY

FI

FI/H/0313/001

20890

BAYER PHARMA AG

SE

FI/H/313/01

BE266384

BAYER SA NV

BE

FI/H/0313/001

BE437132

BAYER SA NV

BE

FI/H/0313/001

HR-H-728666888-01

BAYER DOO

HR

List of nationally authorised medicinal products EMA/590501/2017

Page 2/4

Product name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Nebido 1000 mg/4 ml otopina za injekciju Nebido 1000 mg/4 ml raztopina za injiciranje Nebido 1000 mg/4 ml raztopina za injiciranje Nebido 1000 mg/4 ml solução injetável Nebido 1000 mg/4 ml solução injetável Nebido 1000 mg/4 ml solutie injectabilä Nebido 1000 mg/4 ml solution injectable Nebido 1000 mg/4 ml solution injectable Nebido 1000 mg/4 ml solution injectable Nebido 1000 mg/4 ml, oplossing voor injectie Nebido 1000 mg/4 ml, solution for injection Nebido 1000 mg/4 ml, solution for injection. NEBIDO 1000 mg/4 ml, solution injectable NEBIDO 1000 mg/4 ml, solution injectable Nebido 1000 mg/4ml injektionsvæske, opløsning Nebido 1000 mg/4ml solution for injection Nebido 1000 mg/4ml ενέσιμο διάλυμα

FI/H/0313/001

HR-H-728666888-02

BAYER DOO

HR

FI/H/313/01

H/05/01097/001

BAYER PHARMA AG

SI

FI/H/313/01

H/05/01097/002

BAYER PHARMA AG

SI

FI/H/0313/001

5159587

BAYER PORTUGAL LDA

PT

FI/H/0313/001

5490057

BAYER PORTUGAL LDA

PT

not available

7615/2015/01-02

BAYER PHARMA AG

RO

FI/H/0313/001

BE437132

BAYER SA NV

BE

FI/H/313/01

BE266384

BAYER SA NV

BE

FI/H/0313/001

2007060006

BAYER SA NV

LU

FI/H/0313/001

RVG 30794

BAYER BV

NL

FI/H/0313/001

MA185/02701

BAYER PLC

MT

FI/H/313/01

PL 00010/0549

BAYER PLC

UK

FI/H/0313/001

34009 367 582 7 8

BAYER HEALTHCARE

FR

FI/H/0313/001

34009 277 134 5 3

BAYER HEALTHCARE

FR

FI/H/313/01

36481

BAYER PHARMA AG

DK

FI/H/0313/001

PA 1410/20/1

BAYER LTD

IE

FI/H/0313/001

19681/31-5-2005

BAYER HELLAS SA

CY

List of nationally authorised medicinal products EMA/590501/2017

Page 3/4

Product name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Nebido 1000 mg/4ml ενέσιμο διάλυμα Nebido 250 mg/ml oldatos injekció Nebido 250 mg/ml oldatos injekció Nebido, 1000 mg/4 ml, roztwór do wstrzykiwań Nebido, 1000 mg/4 ml, süstelahus Nebido® 1000 mg Injektionslösung Testosteronundecanoat Reandron 1000 mg/4 ml, solución inyectable. НЕБИДО 250 mg/ml, инжекционен разтвор

FI/H/0313/001

43456/04/12-1-2005

BAYER HELLAS SA

GR

FI/H/0313/001

OGYI-T-10175/01

BAYER PHARMA AG

HU

FI/H/0313/001

OGYI-T-10175/02

BAYER PHARMA AG

HU

FI/H/0313/001

11740

BAYER PHARMA AG

PL

FI/H/313/01

472505

BAYER PHARMA AG

EE

FI/H/0313/001

60074.00.00

JENAPHARM GMBH & CO KG

DE

FI/H/313/01

66.470

BAYER HISPANIA SL

ES

not available

20060085

BAYER PHARMA AG

BG

List of nationally authorised medicinal products EMA/590501/2017

Page 4/4

testosterone undecanoate (injection) - European Medicines Agency

Sep 1, 2017 - Send a question via our website www.ema.europa.eu/contact. © European Medicines Agency, 2017 ... Product name. (in authorisation country).

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