Solymbic

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Withdrawn

This medicine's authorisation has been withdrawn

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

Overview

On 15 June 2018, the European Commission withdrew the marketing authorisation for Solymbic (adalimumab) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Amgen Europe B.V., which notified the European Commission of its decision not to market the product in the EU for commercial reasons. 

Solymbic was granted marketing authorisation in the EU on 22 March 2017 for treatment of rheumatoid arthritis, enthesitis-related arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, paediatric plaque psoriasis, hidradenitis suppurativa, Crohn's disease, paediatric Crohn's disease, ulcerative colitis and non-infectious uveitis. 

Solymbic is a biosimilar medicine of Humira. There are other biosimilar medicinal products of Humira authorised and marketed in the EU. Solymbic was a duplicate application to Amgevita, which is marketed in several EU countries. The marketing authorisation holder will maintain the marketing authorisation for Amgevita. 

The European Public Assessment Report (EPAR) for Solymbic is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

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Product information

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Latest procedure affecting product information: IG/0946
22/06/2018
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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).

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svenska (SV) (508.72 KB - PDF)

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Product details

Name of medicine
Solymbic
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

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

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

Authorisation details

EMA product number
EMEA/H/C/004373

Biosimilar

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.

Marketing authorisation holder
Amgen Europe B.V.

Minervum 7061
4817 ZK Breda
Netherlands

Opinion adopted
15/12/2016
Marketing authorisation issued
22/03/2017
Withdrawal of marketing authorisation
15/06/2018
Revision
2

Assessment history

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