Pramipexole dihydrochloride monohydrate

Adopted

First published: 19/04/2010
Last updated: 19/04/2010
EMEA/466817/2008

Invented name	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