Pramipexole dihydrochloride monohydrate - paediatric investigation plan

pramipexole dihydrochloride monohydrate

Key facts

• Invented name:
  • Sifrol
  • Sifrol
• Active substance:
  pramipexole dihydrochloride monohydrate
• Therapeutic area:
  Neurology
• Decision number:
  P/27/2010
• 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:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  05/03/2010
• Compliance check done:
  Non

Decision

P/27/2010: European medicines agency decision of of 5 March 2010 on the acceptance of a modification of an agreed Paediatric Investigation Plan for pramipexole dihydrochloride (monohydrate) (Sifrol) (EMEA-000041-PIP01-07...

Adopted Reference Number: EMEA/466817/2008