Cyltezo

RSS

adalimumab

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Cyltezo has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 06/03/2019

Authorisation details

Product details
Name
Cyltezo
Agency product number
EMEA/H/C/004319
Active substance
adalimumab
International non-proprietary name (INN) or common name
adalimumab
Therapeutic area (MeSH)
  • Hidradenitis Suppurativa
  • Arthritis, Psoriatic
  • Psoriasis
  • Crohn Disease
  • Arthritis, Juvenile Rheumatoid
  • Uveitis
  • Arthritis, Rheumatoid
  • Colitis, Ulcerative
  • Spondylitis, Ankylosing
Anatomical therapeutic chemical (ATC) code
L04AB04
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

BiosimilarBiosimilar

This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines.

Publication details
Marketing-authorisation holder
Boehringer Ingelheim International GmbH
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
10/11/2017
Contact address
Binger Strasse 173 55216
Ingelheim am Rhein
Germany

Product information

15/01/2019 Cyltezo - EMEA/H/C/004319 - IB/0005/G

Contents

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Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Please refer to section 4.1 of the Summary of product characteristics in the product information document.

Assessment history

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