EMEA-001075-PIP01-10 - paediatric investigation plan

Anti-sclerostin human monoclonal antibody (AMG785)

Key facts

• Active Substance:
  Anti-sclerostin human monoclonal antibody (AMG785)
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/313/2011
• PIP number:
  EMEA-001075-PIP01-10
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of fractures and fracture associated complications
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Amgen Europe B.V

  United Kingdom ; [e-mail] ; + 44 1223420305 ; + 44 1223426814

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  21/12/2011

Decision

P/313/2011: EMA decision of 22 December 2011 on the granting of a product specific waiver for anti-sclerostin human monoclonal antibody (AMG785) (EMEA-001075-PIP01-10)

AdoptedReference Number: EMA/983445/2011