Numient
levodopa / carbidopa
Table of contents
Withdrawn
This medicine is now withdrawn from use in the European Union.
Overview
The marketing authorisation for Numient has been withdrawn at the request of the marketing-authorisation holder.
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List item
Numient : EPAR - Summary for the public (PDF/665.21 KB)
First published: 25/11/2015
Last updated: 25/11/2015 -
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List item
Numient : EPAR - Risk-management-plan summary (PDF/622.55 KB)
First published: 25/11/2015
Last updated: 25/11/2015
This EPAR was last updated on 09/08/2018
Authorisation details
| Product details | |
|---|---|
| Name |
Numient
|
| Agency product number |
EMEA/H/C/002611
|
| Active substance |
|
| International non-proprietary name (INN) or common name |
|
| Therapeutic area (MeSH) |
Parkinson Disease
|
| Anatomical therapeutic chemical (ATC) code |
N04BA02
|
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Amneal Pharma Europe Ltd
|
| Revision |
3
|
| Date of issue of marketing authorisation valid throughout the European Union |
19/11/2015
|
| Contact address |
70 Sir John Rogerson’s Quay
Dublin 2 Ireland |
Product information
03/08/2018 Numient - EMEA/H/C/002611 - T/0005
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Pharmacotherapeutic group
Anti-Parkinson drugs
Therapeutic indication
Therapeutic indication
Symptomatic treatment of adult patients with Parkinson’s disease