Pramipexole dihydrochloride monohydrate - paediatric investigation plan

pramipexole dihydrochloride monohydrate

Key facts

• Invented name:
  • Mirapexin
  • Mirapexin
• Active substance:
  pramipexole dihydrochloride monohydrate
• Therapeutic area:
  Neurology
• Decision number:
  P/75/2008
• PIP number:
  Pramipexole dihydrochloride monohydrate
• Pharmaceutical form(s):
  Immediate release tablet
• Condition(s) / indication(s):
  • Combined vocal and multiple motor tic disorder (de la Tourette)
  • Restless Legs Syndrome
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  12/09/2008
• Compliance check done:
  No

Decision

P/75/2008: European medicines agency decision of 12 September 2008 on the application for agreement of a Paediatric Investigation Plan for pramipexole dihydrochloride monohydrate, (Mirapexin) (EMEA-000080-PIP01-07) in ...

Adopted Reference Number: EMEA/466827/2008