Rivastigmine 3M Health Care Ltd

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Withdrawn

This medicine's authorisation has been withdrawn

rivastigmine
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

On 19 August 2014, the European Commission withdrew the marketing authorisation for Rivastigmine 3M Health Care Ltd (rivastigmine, transdermal patches) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, 3M Health Care Ltd, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Rivastigmine 3M Health Care Ltd was granted marketing authorisation in the EU on 3 April 2014 for the treatment of mild to moderately severe Alzheimer’s dementia. 

Rivastigmine 3M Health Care Ltd is a generic medicine of Exelon. There are other generic medicinal products of Exelon authorised and marketed in the EU. Rivastigmine 3M Health Care Ltd. is an identical product to Rivastigmine Actavis (transdermal patches), which is authorised in the EU to treat patients with mild to moderately severe Alzheimer’s dementia. 

Rivastigmine 3M Health Care Ltd was a duplicate application to Rivastigmine Actavis Transdermal Patches. 

The European Public Assessment Report (EPAR) for Rivastigmine 3M Health Care Ltd is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Rivastigmine 3M Health Care Ltd : EPAR - Summary for the public

Reference Number: EMA/58565/2014

English (EN) (543.73 KB - PDF)

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български (BG) (1.13 MB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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español (ES) (544.14 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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čeština (CS) (674.04 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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dansk (DA) (565.02 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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Deutsch (DE) (546.81 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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eesti keel (ET) (545.38 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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ελληνικά (EL) (640.76 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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français (FR) (567.87 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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hrvatski (HR) (566.41 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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italiano (IT) (542.74 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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latviešu valoda (LV) (625.4 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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lietuvių kalba (LT) (568.62 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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magyar (HU) (602.99 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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Malti (MT) (609.46 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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Nederlands (NL) (549.82 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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polski (PL) (609.98 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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português (PT) (544.77 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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română (RO) (571.48 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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slovenčina (SK) (609.61 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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slovenščina (SL) (1.08 MB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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Suomi (FI) (585.72 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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svenska (SV) (542.13 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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Rivastigmine 3M Health Care Ltd : EPAR - Risk-management-plan summary

English (EN) (554.05 KB - PDF)

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Product information

Rivastigmine 3M Health Care Ltd : EPAR - Product Information

English (EN) (797.74 KB - PDF)

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български (BG) (2.05 MB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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español (ES) (846.28 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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čeština (CS) (1.5 MB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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dansk (DA) (804.55 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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Deutsch (DE) (869.95 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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eesti keel (ET) (829.46 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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ελληνικά (EL) (2.46 MB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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français (FR) (841.22 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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hrvatski (HR) (911.22 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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íslenska (IS) (836.88 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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italiano (IT) (845.3 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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latviešu valoda (LV) (1.66 MB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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lietuvių kalba (LT) (973.26 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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magyar (HU) (1.47 MB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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Malti (MT) (1.62 MB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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Nederlands (NL) (846.75 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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norsk (NO) (799.82 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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polski (PL) (1.62 MB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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português (PT) (851.44 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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română (RO) (1.01 MB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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slovenčina (SK) (1.54 MB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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slovenščina (SL) (1.44 MB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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Suomi (FI) (857.33 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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svenska (SV) (819.74 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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19/08/2014
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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).

Rivastigmine 3M Health Care Ltd : EPAR - All Authorised presentations

English (EN) (479.37 KB - PDF)

First published: Last updated:
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български (BG) (517.34 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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español (ES) (461.14 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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čeština (CS) (500.09 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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dansk (DA) (460.86 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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Deutsch (DE) (460.9 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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eesti keel (ET) (460.65 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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ελληνικά (EL) (500.64 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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français (FR) (460.94 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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hrvatski (HR) (470.73 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
View

íslenska (IS) (460.76 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
View

italiano (IT) (460.77 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
View

latviešu valoda (LV) (488.93 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
View

lietuvių kalba (LT) (474.11 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
View

magyar (HU) (477.82 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
View

Malti (MT) (488.47 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
View

Nederlands (NL) (460.81 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
View

norsk (NO) (460.67 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
View

polski (PL) (478.3 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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português (PT) (460.82 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
View

română (RO) (473.86 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
View

slovenčina (SK) (483.1 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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slovenščina (SL) (485.61 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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Suomi (FI) (460.58 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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svenska (SV) (460.82 KB - PDF)

First published: 14/04/2014Last updated: 18/09/2014
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Product details

Name of medicine
Rivastigmine 3M Health Care Ltd
Active substance
rivastigmine
International non-proprietary name (INN) or common name
rivastigmine
Therapeutic area (MeSH)
Alzheimer Disease
Anatomical therapeutic chemical (ATC) code
N06DA03

Pharmacotherapeutic group

  • Psychoanaleptics
  • Anticholinesterases

Therapeutic indication

Symptomatic treatment of mild to moderately severe Alzheimer's dementia.

Authorisation details

EMA product number
EMEA/H/C/003824

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
3M Health Care Limited

1 Morley Street
Loughborough
Leicestershire
LE11 1EP
United Kingdom

Opinion adopted
23/01/2014
Marketing authorisation issued
03/04/2014
Withdrawal of marketing authorisation
19/08/2014
Revision
1

Assessment history

Rivastigmine 3M Health Care Ltd : EPAR - Public assessment report

AdoptedReference Number: EMA/111203/2014

English (EN) (825.2 KB - PDF)

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CHMP summary of positive opinion for Rivastigmine 3M Health Care Ltd

AdoptedReference Number: EMA/CHMP/25190/2014

English (EN) (543.63 KB - PDF)

First published: Last updated:
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