Daquiran

pramipexole

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About

The marketing authorisation for Daquiran has been withdrawn at the request of the marketing authorisation holder. 

This EPAR was last updated on 23/05/2006 .

Authorisation details

Product details

Product details for Daquiran
NameDaquiran
Agency product numberEMEA/H/C/000135
Active substance

pramipexole dihydrochloride monohydrate

International non-proprietary name (INN) or common name

pramipexole

Therapeutic area Parkinson Disease
Anatomical therapeutic chemical (ATC) code N04BC05

Publication details

Publication details for Daquiran
Marketing-authorisation holder

Dr. Karl Thomae GmbH

Revision5
Date of issue of marketing authorisation valid throughout the European Union27/10/1997

Contact address:

Dr. Karl Thomae GmbH
Birkendorfferstr. 65
D-88397 Biberach/Riss
Germany

Product information

Product information

02/02/2006  Daquiran -EMEA/H/C/000135

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Pharmacotherapeutic group

Anti-parkinson drugs

Therapeutic indication

DAQUIRAN tablets are indicated for treatment of the signs and symptoms of advanced idiopathic Parkinson's disease in combination with levodopa, i.e. over the course of the disease, when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or "on off" fluctuations).

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on Daquiran