Solymbic

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 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.
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.

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

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

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Solymbic : EPAR - Product Information (PDF/2.42 MB)

First published: 07/04/2017
Last updated: 10/07/2018
- Bulgarian
  (PDF/6.02 MB)
- Croatian
  (PDF/3.68 MB)
- Czech
  (PDF/4.92 MB)
- Danish
  (PDF/3.35 MB)
- Dutch
  (PDF/3.65 MB)
- Estonian
  (PDF/3.27 MB)
- Finnish
  (PDF/3.75 MB)
- French
  (PDF/3.98 MB)
- German
  (PDF/3.56 MB)
- Greek
  (PDF/6.23 MB)
- Hungarian
  (PDF/5.02 MB)
- Icelandic
  (PDF/3.59 MB)
- Italian
  (PDF/3.92 MB)
- Latvian
  (PDF/5.05 MB)
- Lithuanian
  (PDF/3.84 MB)
- Maltese
  (PDF/5.28 MB)
- Norwegian
  (PDF/3.45 MB)
- Polish
  (PDF/5.13 MB)
- Portuguese
  (PDF/3.53 MB)
- Romanian
  (PDF/3.89 MB)
- Slovak
  (PDF/4.89 MB)
- Slovenian
  (PDF/4.87 MB)
- Spanish
  (PDF/3.85 MB)
- Swedish
  (PDF/3.54 MB)

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:

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).

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.

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Solymbic : EPAR - All Authorised presentations (PDF/514.38 KB)

First published: 07/04/2017
Last updated: 07/04/2017
- Bulgarian
  (PDF/536.38 KB)
- Croatian
  (PDF/511.79 KB)
- Czech
  (PDF/532.17 KB)
- Danish
  (PDF/511.23 KB)
- Dutch
  (PDF/507.42 KB)
- Estonian
  (PDF/505.94 KB)
- Finnish
  (PDF/514.13 KB)
- French
  (PDF/509.49 KB)
- German
  (PDF/508.32 KB)
- Greek
  (PDF/549.49 KB)
- Hungarian
  (PDF/522.74 KB)
- Icelandic
  (PDF/509.58 KB)
- Italian
  (PDF/513.63 KB)
- Latvian
  (PDF/193.56 KB)
- Lithuanian
  (PDF/509.22 KB)
- Maltese
  (PDF/534.14 KB)
- Norwegian
  (PDF/507.91 KB)
- Polish
  (PDF/527.71 KB)
- Portuguese
  (PDF/508.73 KB)
- Romanian
  (PDF/512.04 KB)
- Slovak
  (PDF/525.69 KB)
- Slovenian
  (PDF/520.52 KB)
- Spanish
  (PDF/508.28 KB)
- Swedish
  (PDF/508.72 KB)

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

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

Table of contents

Overview

Solymbic : EPAR - Summary for the public (PDF/580.37 KB)

Authorisation details

Product information

Solymbic : EPAR - Product Information (PDF/2.42 MB)

Solymbic : EPAR - All Authorised presentations (PDF/514.38 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Solymbic : EPAR - Procedural steps taken and scientific information after authorisation (PDF/1.46 MB)

Initial marketing-authorisation documents

Solymbic : EPAR - Public assessment report (PDF/6.66 MB)

CHMP summary of positive opinion for Solymbic (PDF/559.71 KB)

News

Related content

More information on Solymbic

Public statement on Solymbic: Withdrawal of the marketing authorisation in the European Union (PDF/59.31 KB)

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