Solymbic

RSS

adalimumab

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Solymbic has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 05/03/2019

Authorisation details

Product details
Name
Solymbic
Agency product number
EMEA/H/C/004373
Active substance
adalimumab
International non-proprietary name (INN) or common name
adalimumab
Therapeutic area (MeSH)
  • Arthritis, Psoriatic
  • Spondylitis, Ankylosing
  • Crohn Disease
  • Colitis, Ulcerative
  • Hidradenitis Suppurativa
  • Psoriasis
  • Arthritis, Rheumatoid
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
Amgen Europe B.V.
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
22/03/2017
Contact address
Minervum 7061
4817 ZK Breda
Netherlands

Product information

22/06/2018 Solymbic - EMEA/H/C/004373 - IG/0946

Other EU languages available icon 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:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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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