EMEA-001135-PIP01-11 - paediatric investigation plan

teriparatide

Key facts

• Invented name:
  • Forsteo
  • Forsteo
• Active substance:
  teriparatide
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/189/2011
• PIP number:
  EMEA-001135-PIP01-11
• Pharmaceutical form(s):
  • Solution for injection in pre-filled pen
  • Transdermal system
• Condition(s) / indication(s):
  • Treatment of fractures
  • Treatment of osteoporosis
• Route(s) of administration:
  • Subcutaneous use
  • Transdermal use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  02/08/2011
• Compliance check done:
  No

Decision

P/189/2011: EMA decision of 2 August 2011 on the granting of a product specific waiver for teriparatide (Forsteo), (EMEA-001135-PIP01-11)

Adopted Reference Number: EMA/507484/2011