- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
The marketing authorisation for Rivastigmine Teva has been withdrawn at the request of the marketing-authorisation holder.
Rivastigmine Teva : EPAR - Summary for the public
English (EN) (261.34 KB - PDF)
български (BG) (423.44 KB - PDF)
español (ES) (262.58 KB - PDF)
čeština (CS) (395.3 KB - PDF)
dansk (DA) (262.01 KB - PDF)
Deutsch (DE) (499.95 KB - PDF)
eesti keel (ET) (261.35 KB - PDF)
ελληνικά (EL) (420.4 KB - PDF)
français (FR) (262.84 KB - PDF)
italiano (IT) (262.38 KB - PDF)
latviešu valoda (LV) (400.85 KB - PDF)
lietuvių kalba (LT) (373.57 KB - PDF)
magyar (HU) (386.87 KB - PDF)
Malti (MT) (400.17 KB - PDF)
Nederlands (NL) (262.67 KB - PDF)
polski (PL) (403.91 KB - PDF)
português (PT) (262.56 KB - PDF)
română (RO) (369.47 KB - PDF)
slovenčina (SK) (391.71 KB - PDF)
slovenščina (SL) (383.63 KB - PDF)
Suomi (FI) (261.66 KB - PDF)
svenska (SV) (261.87 KB - PDF)
Product information
Rivastigmine Teva : EPAR - Product Information
English (EN) (2.28 MB - PDF)
български (BG) (4.15 MB - PDF)
español (ES) (1.71 MB - PDF)
čeština (CS) (1.93 MB - PDF)
dansk (DA) (1018.67 KB - PDF)
Deutsch (DE) (1.76 MB - PDF)
eesti keel (ET) (821.55 KB - PDF)
ελληνικά (EL) (2.64 MB - PDF)
français (FR) (860.43 KB - PDF)
íslenska (IS) (954.26 KB - PDF)
italiano (IT) (892.86 KB - PDF)
latviešu valoda (LV) (3.07 MB - PDF)
lietuvių kalba (LT) (1.05 MB - PDF)
magyar (HU) (1.72 MB - PDF)
Malti (MT) (1.79 MB - PDF)
Nederlands (NL) (881.7 KB - PDF)
norsk (NO) (873.22 KB - PDF)
polski (PL) (3.36 MB - PDF)
português (PT) (2.27 MB - PDF)
română (RO) (1.05 MB - PDF)
slovenčina (SK) (1.79 MB - PDF)
slovenščina (SL) (1.82 MB - PDF)
Suomi (FI) (846.15 KB - PDF)
svenska (SV) (1.02 MB - PDF)
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).
Rivastigmine Teva : EPAR - All Authorised presentations
English (EN) (228.43 KB - PDF)
български (BG) (315.28 KB - PDF)
español (ES) (228.79 KB - PDF)
čeština (CS) (304.54 KB - PDF)
dansk (DA) (229.13 KB - PDF)
Deutsch (DE) (228.83 KB - PDF)
eesti keel (ET) (228.75 KB - PDF)
ελληνικά (EL) (313.73 KB - PDF)
français (FR) (229 KB - PDF)
íslenska (IS) (228.86 KB - PDF)
italiano (IT) (228.36 KB - PDF)
latviešu valoda (LV) (308.06 KB - PDF)
lietuvių kalba (LT) (298.36 KB - PDF)
magyar (HU) (308.18 KB - PDF)
Malti (MT) (305.81 KB - PDF)
Nederlands (NL) (227.93 KB - PDF)
norsk (NO) (228.31 KB - PDF)
polski (PL) (307.29 KB - PDF)
português (PT) (228.76 KB - PDF)
română (RO) (295.64 KB - PDF)
slovenčina (SK) (305.67 KB - PDF)
slovenščina (SL) (237.64 KB - PDF)
Suomi (FI) (228.53 KB - PDF)
svenska (SV) (228.48 KB - PDF)
Product details
- Name of medicine
- Rivastigmine Teva
- Active substance
- rivastigmine
- International non-proprietary name (INN) or common name
- rivastigmine
- Therapeutic area (MeSH)
- Dementia
- Alzheimer Disease
- Parkinson Disease
- Anatomical therapeutic chemical (ATC) code
- N06DA03
Pharmacotherapeutic group
AnticholinesterasesTherapeutic indication
Symptomatic treatment of mild to moderately severe Alzheimer's dementia.
Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.
Authorisation details
- EMA product number
- EMEA/H/C/001044
Generic
This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.
- Marketing authorisation holder
- Teva Pharma B.V.
Computerweg 10
NL-3542 DR Utrecht
The Netherlands - Marketing authorisation issued
- 17/04/2009
- Revision
- 4
Assessment history
Rivastigmine Teva : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (279.36 KB - PDF)
Rivastigmine Teva : EPAR - Public assessment report
English (EN) (628.59 KB - PDF)
Committee for medicinal products for human use, summary of positive opinion for Rivastigmine Teva
English (EN) (32.86 KB - PDF)
More information on Rivastigmine Teva
Public statement on Rivastigmine Teva: Withdrawal of the marketing authorisation in the European Union
English (EN) (86.58 KB - PDF)