Leflunomide Teva

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leflunomide

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Leflunomide Teva has lapsed because it has not been marketed in the European Union in the three years following the granting of the authorisation.

This EPAR was last updated on 18/03/2014

Authorisation details

Product details
Name
Leflunomide Teva
Agency product number
EMEA/H/C/002356
Active substance
leflunomide
International non-proprietary name (INN) or common name
leflunomide
Therapeutic area (MeSH)
Arthritis, Rheumatoid
Anatomical therapeutic chemical (ATC) code
L04AA13
GenericGeneric

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.

Publication details
Marketing-authorisation holder
Teva Pharma B.V.
Revision
6
Date of issue of marketing authorisation valid throughout the European Union
10/03/2011
Contact address
Computerweg 10
NL-3542 DR Utrecht
The Netherlands

Product information

15/01/2014 Leflunomide Teva - EMEA/H/C/002356 - N/0011

Contents

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Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Leflunomide is indicated for the treatment of adult patients with active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (DMARD).

Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) may result in an increased risk of serious adverse reactions; therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit / risk aspects.

Moreover, switching from leflunomide to another DMARD without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching.

Assessment history

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