Pramipexole dihydrochloride monohydrate

Adopted

First published: 10/10/2008
Last updated: 10/10/2008
EMEA/466827/2008

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
Decision type	P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)