P/23/211 - paediatric investigation plan

tesamorelin

Key facts

• Active Substance:
  tesamorelin
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/23/2011
• PIP number:
  P/23/211
• Pharmaceutical form(s):
  Lyophilisate for solution for injection
• Condition(s) / indication(s):
  Treatment of HIV-associated lipodystrophy
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Theratechnologies Inc

  [e-mail]; Canada; Phone: [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  23/01/2011

Decision

P/23/2011: EMA decision of 25 January 2011 on the granting of a product specific waiver for tesamorelin (EMEA-001029-PIP01-10) in accordance with Regulation (EC) No 1901/2006 of the European Parliament and of the Counci...

AdoptedReference Number: EMA/51098/2011