EMEA-001859-PIP02-15 - paediatric investigation plan

Recombinant human monoclonal antibody against growth differentiation factor 8 (REGN1033)

Key facts

• Active Substance:
  Recombinant human monoclonal antibody against growth differentiation factor 8 (REGN1033)
• Therapeutic area:
  Neurology
• Decision number:
  P/0086/2016
• PIP number:
  EMEA-001859-PIP02-15
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of sporadic inclusion body myositis
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Regeneron Pharmaceuticals, Inc

  USA; Tel. [phone]; E-mail: [e-mail]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  18/03/2016

Decision

P/0086/2016: EMA decision of 18 March 2016 on the granting of a product specific waiver for recombinant human monoclonal antibody against growth differentiation factor 8 (REGN1033) (EMEA-001859-PIP02-15)

AdoptedReference Number: EMA/107873/2016