Numient

RSS

levodopa / carbidopa

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Numient. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Numient.

For practical information about using Numient, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 09/08/2018

Authorisation details

Product details
Name
Numient
Agency product number
EMEA/H/C/002611
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
Publication details
Marketing-authorisation holder
Amneal Pharma Europe Ltd
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
18/11/2015
Contact address
70 Sir John Rogerson’s Quay
Dublin 2
Ireland

Product information

02/08/2018 Numient - EMEA/H/C/002611 - T/0005

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

Symptomatic treatment of adult patients with Parkinson’s disease

Assessment history

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