Pramipexole dihydrochloride monohydrate

Key facts

Invented name
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
Contact for public enquiries
Applicant: Boehringer Ingelheim International GmbH
E-mail: paediatrics@boehringer-ingelheim.com
Country: Germany
Phone: +49 6132778271
Fax: +49 6132776601
Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)

Decision

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