Daquiran
Withdrawn
This medicine's authorisation has been withdrawn
pramipexole
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 27 October 1997 the European Commission granted a marketing authorisation for the whole European Union to Dr. Karl Thomae GmbH, for Daquiran (pramipexole), 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). Daquiran was not marketed anywhere in the European Union.
On 22 December 2005 the Marketing Authorisation Holder notified the European Commission of its decision to voluntarily withdraw the Marketing Authorisation for Daquiran as there were no plans to market this product in the future. It should be noted that there are still two Community Marketing Authorisations valid throughout the European Union for pramipexole i.e. Sifrol and Mirapexin.
On 2 February 2006 the European Commission adopted the decision withdrawing the Marketing Authorisation for the medicinal product for human use "Daquiran".
Pursuant to this decision the European Public Assessment Report for Daquiran has been removed from the EMA website.
Product information
02/02/2006
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Daquiran
- Active substance
- pramipexole dihydrochloride monohydrate
- International non-proprietary name (INN) or common name
- pramipexole
- Therapeutic area (MeSH)
- Parkinson Disease
- Anatomical therapeutic chemical (ATC) code
- N04BC05
Pharmacotherapeutic group
Anti-Parkinson drugsTherapeutic 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).
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