NEBIDO

Main information

  • Trade name:
  • NEBIDO Solution for Injection 250 Milligram
  • Available from:
  • Bayer Limited
  • Dosage:
  • 250 Milligram
  • Pharmaceutical form:
  • Solution for Injection
  • Medicine type:
  • Human

Localization

  • Available in:
  • Ireland
  • Language:
  • English

Therapeutic information

Status

  • Source:
  • IMB
  • Authorization date:
  • 2007-11-30

Documents

2-12-2014

CMDh News – November 2014

The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), a regulatory body representing EU Member States, has endorsed new recommendations on testosterone-containing medicines, valproate – containing medicines and related active substances, continued with the implementation of the outcome of the referral for Tazocin and medicinal product with associated names. and endorsed the new version of the Core SmPC/PL. More information is accessible under the link bel...

Croatia - HALMED - Medicines Agency of Croatia

2-12-2014

Danish Pharmacovigilance Update, November 2014

Five years ago, we issued Danish Pharmacovigilance Update for the first time. We are delighted to celebrate the newsletter's fifth anniversary with more than 3,000 subscribers to the Danish and the English version, and we hope the interest in Danish Pharmacovigilance Update will continue to grow. You can sign up for the newsletter on our website under News – click Subscribe and tick off 'Medicines safety' under Medicines. Among the articles in this issue, you can read about how we have develo...

Danish Medicines Agency

14-10-2014

PRAC News – October 2014

The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended strengthening the restrictions on the use of valproate in women and girls, concluded that there is no evidence that testosterone-containing medicines increase the cardiovascular risk in patients with hypogonadism and recommended further measures to minimise risk of blood vessel blockage with ponatinib at its October 2014 meeting. More information is accessible under the link below.

Croatia - HALMED - Medicines Agency of Croatia

14-10-2014

Monthly report from the EU Pharmacovigilance Risk Assessment Committee (PRAC) - October 2014

The EU Pharmacovigilance Risk Assessment Committee (PRAC) convened on 6-9 October 2014. Topics discussed at the meeting: PRAC recommends strengthening the restrictions on the use of valproate in women and girls PRAC review does not confirm increase in heart problems with testosterone medicines PRAC recommends further measures to minimise risk of blood vessel blockage with Iclusig Five days left to respond to the consultation on public hearings Read PRAC's monthly report from the meeti...

Danish Medicines Agency

14-7-2015

TESTOSTERONE CYPIONATE Injection, Solution [Actavis Pharma, Inc.]

Updated Date: Jul 14, 2015 EST

US - DailyMed

19-6-2015

TESTOSTERONE ENANTHATE Injection, Solution [West-Ward Pharmaceutical Corp]

Updated Date: Jun 19, 2015 EST

US - DailyMed

10-6-2015

ANDRODERM (Testosterone) Patch [Actavis Pharma, Inc.]

Updated Date: Jun 10, 2015 EST

US - DailyMed

22-5-2015

TESTOSTERONE Gel, Metered [Qualitest Pharmaceuticals]

Updated Date: May 22, 2015 EST

US - DailyMed

21-5-2015

TESTOSTERONE Gel [Prasco Laboratories]

Updated Date: May 21, 2015 EST

US - DailyMed

20-5-2015

FORTESTA (Testosterone) Gel, Metered [Endo Pharmaceuticals Inc.]

Updated Date: May 20, 2015 EST

US - DailyMed

20-5-2015

TESTOSTERONE CYPIONATE Injection, Solution [Sun Pharmaceutical Industries Limited ]

Updated Date: May 20, 2015 EST

US - DailyMed

20-5-2015

AVEED (Testosterone Undecanoate) Injection [Endo Pharmaceuticals Solutions Inc.]

Updated Date: May 20, 2015 EST

US - DailyMed

19-5-2015

TESTOSTERONE Gel TESTOSTERONE Gel, Metered [Upsher-Smith Laboratories, Inc.]

Updated Date: May 19, 2015 EST

US - DailyMed

18-5-2015

ANDROGEL (Testosterone) Gel [AbbVie Inc.]

Updated Date: May 18, 2015 EST

US - DailyMed

28-4-2015

TESTONE CIK (Testosterone Cypionate, Alcohol) Kit [Asclemed USA, Inc.]

Updated Date: Apr 28, 2015 EST

US - DailyMed

13-4-2015

TESTOSTERONE CYPIONATE Injection, Solution [Paddock Laboratories, LLC]

Updated Date: Apr 13, 2015 EST

US - DailyMed

12-3-2015

NATESTO (Testosterone) Gel [Endo Pharmaceuticals]

Updated Date: Mar 12, 2015 EST

US - DailyMed

6-3-2015

AXIRON (Testosterone) Solution [Eli Lilly And Company ]

Updated Date: Mar 6, 2015 EST

US - DailyMed

6-3-2015

TESTOSTERONE CYPIONATE Injection [Actavis Pharma, Inc.]

Updated Date: Mar 6, 2015 EST

US - DailyMed

30-1-2015

NATESTO NASAL GEL (Testosterone) Gel, Metered [Trimel Pharmaceuticals Corporation]

Updated Date: Jan 30, 2015 EST

US - DailyMed

29-1-2015

ANDROGEL (Testosterone) Gel [A-S Medication Solutions LLC]

Updated Date: Jan 29, 2015 EST

US - DailyMed

26-1-2015

TESTOPEL (Testosterone) Pellet [Auxilium Pharmaceuticals, Inc.]

Updated Date: Jan 26, 2015 EST

US - DailyMed

22-1-2015

TESTOSTERONE CYPIONATE Injection [West-Ward Pharmaceutical Corp]

Updated Date: Jan 22, 2015 EST

US - DailyMed

20-1-2015

STRIANT (Testosterone) Tablet [Actient Pharmaceuticals LLC]

Updated Date: Jan 20, 2015 EST

US - DailyMed

20-1-2015

TESTIM (Testosterone) Gel [Auxilium Pharmaceuticals, Inc.]

Updated Date: Jan 20, 2015 EST

US - DailyMed

13-1-2015

TESTOSTERONE Gel [Perrigo New York Inc]

Updated Date: Jan 13, 2015 EST

US - DailyMed

22-12-2014

TESTOSTERONE CYPIONATE Injection, Solution [A-S Medication Solutions LLC]

Updated Date: Dec 22, 2014 EST

US - DailyMed

22-12-2014

TESTOSTERONE CYPIONATE Injection [A-S Medication Solutions LLC]

Updated Date: Dec 22, 2014 EST

US - DailyMed

22-12-2014

TESTIM (Testosterone) Gel [A-S Medication Solutions LLC]

Updated Date: Dec 22, 2014 EST

US - DailyMed

21-11-2014

News and press releases: No consistent evidence of an increased risk of heart problems with testosterone medicines

The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), a regulatory body representing EU Member States, has agreed by consensus that there is no consistent evidence of an increased risk of heart problems with testosterone medicines in men who lack the hormone (a condition known as hypogonadism)

Europe - EMA - European Medicines Agency

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