Numient
Withdrawn
This medicine's authorisation has been withdrawn
levodopa / carbidopa
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 2 April 2019, the European Commission withdrew the marketing authorisation for Numient (levodopa / carbidopa) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Amneal Pharma Europe Limited, which notified the European Commission of its decision not to market the product in the EU for commercial reasons.
Numient was granted marketing authorisation in the EU on 19 November 2015 for symptomatic treatment of adult patients with Parkinson’s disease. The marketing authorisation was initially valid for a 5-year period. The product had not been marketed in the EU.
The European Public Assessment Report (EPAR) for Numient is updated to indicate that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:
T/0005
03/08/2018
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
- Numient
- Active substance
- levodopa
- carbidopa
- International non-proprietary name (INN) or common name
- levodopa
- carbidopa
- Therapeutic area (MeSH)
- Parkinson Disease
- Anatomical therapeutic chemical (ATC) code
- N04BA02
Pharmacotherapeutic group
Anti-Parkinson drugsTherapeutic indication
Symptomatic treatment of adult patients with Parkinson’s disease
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