Pramipexole dihydrochloride monohydrate - paediatric investigation plan
pramipexole dihydrochloride monohydrate
PIPHuman
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
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 ...