Numient

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Withdrawn

This medicine's authorisation has been withdrawn

levodopa / carbidopa
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

The marketing authorisation for Numient has been withdrawn at the request of the marketing-authorisation holder.

Numient : EPAR - Summary for the public

English (EN) (665.21 KB - PDF)

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български (BG) (760.76 KB - PDF)

First published: 25/11/2015Last updated: 25/11/2015
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español (ES) (664.35 KB - PDF)

First published: 25/11/2015Last updated: 25/11/2015
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čeština (CS) (734.48 KB - PDF)

First published: 25/11/2015Last updated: 25/11/2015
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dansk (DA) (661.04 KB - PDF)

First published: 25/11/2015Last updated: 25/11/2015
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Deutsch (DE) (665.21 KB - PDF)

First published: 25/11/2015Last updated: 25/11/2015
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eesti keel (ET) (660.8 KB - PDF)

First published: 25/11/2015Last updated: 25/11/2015
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ελληνικά (EL) (765.87 KB - PDF)

First published: 25/11/2015Last updated: 25/11/2015
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français (FR) (664.34 KB - PDF)

First published: 25/11/2015Last updated: 25/11/2015
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hrvatski (HR) (686.65 KB - PDF)

First published: 25/11/2015Last updated: 25/11/2015
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italiano (IT) (661.99 KB - PDF)

First published: 25/11/2015Last updated: 25/11/2015
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latviešu valoda (LV) (738.18 KB - PDF)

First published: 25/11/2015Last updated: 25/11/2015
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lietuvių kalba (LT) (1.25 MB - PDF)

First published: 25/11/2015Last updated: 25/11/2015
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magyar (HU) (733.46 KB - PDF)

First published: 25/11/2015Last updated: 25/11/2015
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Malti (MT) (743.54 KB - PDF)

First published: 25/11/2015Last updated: 25/11/2015
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Nederlands (NL) (662.11 KB - PDF)

First published: 25/11/2015Last updated: 25/11/2015
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polski (PL) (692 KB - PDF)

First published: 25/11/2015Last updated: 25/11/2015
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português (PT) (663.31 KB - PDF)

First published: 25/11/2015Last updated: 25/11/2015
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română (RO) (688.99 KB - PDF)

First published: 25/11/2015Last updated: 25/11/2015
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slovenčina (SK) (738.22 KB - PDF)

First published: 25/11/2015Last updated: 25/11/2015
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slovenščina (SL) (730.81 KB - PDF)

First published: 25/11/2015Last updated: 25/11/2015
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Suomi (FI) (661.6 KB - PDF)

First published: 25/11/2015Last updated: 25/11/2015
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svenska (SV) (662.58 KB - PDF)

First published: 25/11/2015Last updated: 25/11/2015
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Numient : EPAR - Risk-management-plan summary

English (EN) (622.55 KB - PDF)

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Product information

Numient : EPAR - Product Information

English (EN) (1.18 MB - PDF)

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български (BG) (2.27 MB - PDF)

First published: 25/11/2015Last updated: 09/08/2018
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español (ES) (1.22 MB - PDF)

First published: 25/11/2015Last updated: 09/08/2018
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čeština (CS) (1.91 MB - PDF)

First published: 25/11/2015Last updated: 09/08/2018
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dansk (DA) (988.75 KB - PDF)

First published: 25/11/2015Last updated: 09/08/2018
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Deutsch (DE) (1.29 MB - PDF)

First published: 25/11/2015Last updated: 09/08/2018
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eesti keel (ET) (1.29 MB - PDF)

First published: 25/11/2015Last updated: 09/08/2018
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ελληνικά (EL) (2.32 MB - PDF)

First published: 25/11/2015Last updated: 09/08/2018
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français (FR) (1.31 MB - PDF)

First published: 25/11/2015Last updated: 09/08/2018
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hrvatski (HR) (1.35 MB - PDF)

First published: 25/11/2015Last updated: 09/08/2018
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íslenska (IS) (1.24 MB - PDF)

First published: 25/11/2015Last updated: 09/08/2018
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italiano (IT) (1.28 MB - PDF)

First published: 25/11/2015Last updated: 09/08/2018
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latviešu valoda (LV) (2.04 MB - PDF)

First published: 25/11/2015Last updated: 09/08/2018
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lietuvių kalba (LT) (1.34 MB - PDF)

First published: 25/11/2015Last updated: 09/08/2018
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magyar (HU) (1.91 MB - PDF)

First published: 25/11/2015Last updated: 09/08/2018
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Malti (MT) (1.93 MB - PDF)

First published: 25/11/2015Last updated: 09/08/2018
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Nederlands (NL) (1.27 MB - PDF)

First published: 25/11/2015Last updated: 09/08/2018
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norsk (NO) (1.15 MB - PDF)

First published: 25/11/2015Last updated: 09/08/2018
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polski (PL) (1.36 MB - PDF)

First published: 25/11/2015Last updated: 09/08/2018
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português (PT) (1.26 MB - PDF)

First published: 25/11/2015Last updated: 09/08/2018
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română (RO) (1.36 MB - PDF)

First published: 25/11/2015Last updated: 09/08/2018
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slovenčina (SK) (1.91 MB - PDF)

First published: 25/11/2015Last updated: 09/08/2018
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slovenščina (SL) (1.92 MB - PDF)

First published: 25/11/2015Last updated: 09/08/2018
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Suomi (FI) (1.26 MB - PDF)

First published: 25/11/2015Last updated: 09/08/2018
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svenska (SV) (1.25 MB - PDF)

First published: 25/11/2015Last updated: 09/08/2018
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Latest procedure affecting product information: T/0005
03/08/2018
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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).

Numient : EPAR - All Authorised presentations

English (EN) (1.14 MB - PDF)

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български (BG) (663.12 KB - PDF)

First published: 25/11/2015Last updated: 25/11/2015
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español (ES) (592.52 KB - PDF)

First published: 25/11/2015Last updated: 25/11/2015
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čeština (CS) (641.3 KB - PDF)

First published: 25/11/2015Last updated: 25/11/2015
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dansk (DA) (593.46 KB - PDF)

First published: 25/11/2015Last updated: 25/11/2015
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Deutsch (DE) (596.9 KB - PDF)

First published: 25/11/2015Last updated: 25/11/2015
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eesti keel (ET) (596.6 KB - PDF)

First published: 25/11/2015Last updated: 25/11/2015
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ελληνικά (EL) (659.83 KB - PDF)

First published: 25/11/2015Last updated: 25/11/2015
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français (FR) (593.43 KB - PDF)

First published: 25/11/2015Last updated: 25/11/2015
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hrvatski (HR) (612.12 KB - PDF)

First published: 25/11/2015Last updated: 25/11/2015
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íslenska (IS) (593.23 KB - PDF)

First published: 25/11/2015Last updated: 25/11/2015
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italiano (IT) (593.46 KB - PDF)

First published: 25/11/2015Last updated: 25/11/2015
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latviešu valoda (LV) (626.17 KB - PDF)

First published: 25/11/2015Last updated: 25/11/2015
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lietuvių kalba (LT) (609.67 KB - PDF)

First published: 25/11/2015Last updated: 25/11/2015
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magyar (HU) (632.86 KB - PDF)

First published: 25/11/2015Last updated: 25/11/2015
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Malti (MT) (621.02 KB - PDF)

First published: 25/11/2015Last updated: 25/11/2015
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Nederlands (NL) (592.57 KB - PDF)

First published: 25/11/2015Last updated: 25/11/2015
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norsk (NO) (592.7 KB - PDF)

First published: 25/11/2015Last updated: 25/11/2015
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polski (PL) (33.46 KB - PDF)

First published: 25/11/2015Last updated: 25/11/2015
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português (PT) (595.16 KB - PDF)

First published: 25/11/2015Last updated: 25/11/2015
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română (RO) (607.16 KB - PDF)

First published: 25/11/2015Last updated: 25/11/2015
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slovenčina (SK) (622.14 KB - PDF)

First published: 25/11/2015Last updated: 25/11/2015
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slovenščina (SL) (619.27 KB - PDF)

First published: 25/11/2015Last updated: 25/11/2015
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Suomi (FI) (595.79 KB - PDF)

First published: 25/11/2015Last updated: 25/11/2015
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svenska (SV) (593 KB - PDF)

First published: 25/11/2015Last updated: 25/11/2015
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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 drugs

Therapeutic indication

Symptomatic treatment of adult patients with Parkinson’s disease

Authorisation details

EMA product number
EMEA/H/C/002611
Marketing authorisation holder
Amneal Pharma Europe Ltd

70 Sir John Rogerson’s Quay
Dublin 2
Ireland

Opinion adopted
24/09/2015
Marketing authorisation issued
19/11/2015
Revision
3

Assessment history

Numient : EPAR - Procedural steps taken and scientific information after authorisation

English (EN) (654.25 KB - PDF)

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Numient : EPAR - Public assessment report

AdoptedReference Number: EMA/CHMP/672104/2015

English (EN) (3.78 MB - PDF)

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CHMP summary of positive opinion Numient

AdoptedReference Number: EMA/CHMP/519889/2015

English (EN) (643.5 KB - PDF)

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More information on Numient

Public statement on Numient : Withdrawal of the marketing authorisation in the European Union

AdoptedReference Number: EMEA/H/C/002611

English (EN) (117.82 KB - PDF)

First published:
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