EMEA-000433-PIP01-08 - paediatric investigation plan

Dirucotide acetate

Key facts

• Active Substance:
  Dirucotide acetate
• Therapeutic area:
  Neurology
• Decision number:
  P/43/2009
• PIP number:
  EMEA-000433-PIP01-08
• Pharmaceutical form(s):
  Powder for solution for injection
• Condition(s) / indication(s):
  Multiple Sclerosis
• Route(s) of administration:
  Intravenous use
• Decision type:
  RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
• Decision date:
  23/03/2009

Decision

P/43/2009: European Medicines Agency decision of 23 March 2009 on the refusal of a product specific waiver for dirucotide acetate (EMEA-000433-PIP01-08) in accordance with Regulation (EC) No 1901/2006 of the European Par...

AdoptedReference Number: EMEA/167848/2009