EMEA-001029-PIP01-10 - paediatric investigation plan

tesamorelin

Key facts

• Active substance:
  tesamorelin
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/23/2011
• PIP number:
  EMEA-001029-PIP01-10
• Pharmaceutical form(s):
  Lyophilisate for solution for injection
• Condition(s) / indication(s):
  Treatment of HIV-associated lipodystrophy
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  23/01/2011
• Compliance check done:
  No

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...

Adopted Reference Number: EMA/51098/2011