EMEA-001286-PIP01-12 - paediatric investigation plan

recombinant human antibody against activin type IIB receptors

Key facts

• Active Substance:
  recombinant human antibody against activin type IIB receptors
• Therapeutic area:
  Neurology
• Decision number:
  P/0201/2012
• PIP number:
  EMEA-001286-PIP01-12
• Pharmaceutical form(s):
  Concentrate for solution for injection
• Condition(s) / indication(s):
  Treatment of sporadic inclusion body myositis
• Route(s) of administration:
  • Intravenous use
  • Subcutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  24/08/2012

Decision

P/0201/2012: EMA decision of 24 August 2012 on the granting of a product specific waiver for recombinant human antibody against activin type IIB receptors (EMEA-001286-PIP01-12)

AdoptedReference Number: EMA/534269/2012