Overview

The marketing authorisation for Solymbic has been withdrawn at the request of the marketing-authorisation holder.

Solymbic : EPAR - Summary for the public

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ελληνικά (EL) (671.55 KB - PDF)

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italiano (IT) (556.94 KB - PDF)

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latviešu valoda (LV) (275.58 KB - PDF)

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polski (PL) (639.92 KB - PDF)

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português (PT) (559.5 KB - PDF)

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română (RO) (588.68 KB - PDF)

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slovenčina (SK) (624.71 KB - PDF)

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slovenščina (SL) (615.65 KB - PDF)

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Suomi (FI) (553.67 KB - PDF)

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svenska (SV) (554.21 KB - PDF)

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Product information

Solymbic : EPAR - Product Information

English (EN) (2.42 MB - PDF)

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български (BG) (6.02 MB - PDF)

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español (ES) (3.85 MB - PDF)

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čeština (CS) (4.92 MB - PDF)

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dansk (DA) (3.35 MB - PDF)

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Deutsch (DE) (3.56 MB - PDF)

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eesti keel (ET) (3.27 MB - PDF)

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ελληνικά (EL) (6.23 MB - PDF)

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français (FR) (3.98 MB - PDF)

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hrvatski (HR) (3.68 MB - PDF)

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íslenska (IS) (3.59 MB - PDF)

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italiano (IT) (3.92 MB - PDF)

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latviešu valoda (LV) (5.05 MB - PDF)

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lietuvių kalba (LT) (3.84 MB - PDF)

First published: 07/04/2017Last updated: 10/07/2018
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magyar (HU) (5.02 MB - PDF)

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Malti (MT) (5.28 MB - PDF)

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Nederlands (NL) (3.65 MB - PDF)

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norsk (NO) (3.45 MB - PDF)

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polski (PL) (5.13 MB - PDF)

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português (PT) (3.53 MB - PDF)

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română (RO) (3.89 MB - PDF)

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slovenčina (SK) (4.89 MB - PDF)

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slovenščina (SL) (4.87 MB - PDF)

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Suomi (FI) (3.75 MB - PDF)

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svenska (SV) (3.54 MB - PDF)

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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.
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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).

Solymbic : EPAR - All Authorised presentations

English (EN) (514.38 KB - PDF)

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български (BG) (536.38 KB - PDF)

First published: 07/04/2017Last updated: 07/04/2017
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español (ES) (508.28 KB - PDF)

First published: 07/04/2017Last updated: 07/04/2017
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čeština (CS) (532.17 KB - PDF)

First published: 07/04/2017Last updated: 07/04/2017
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dansk (DA) (511.23 KB - PDF)

First published: 07/04/2017Last updated: 07/04/2017
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Deutsch (DE) (508.32 KB - PDF)

First published: 07/04/2017Last updated: 07/04/2017
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eesti keel (ET) (505.94 KB - PDF)

First published: 07/04/2017Last updated: 07/04/2017
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ελληνικά (EL) (549.49 KB - PDF)

First published: 07/04/2017Last updated: 07/04/2017
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français (FR) (509.49 KB - PDF)

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hrvatski (HR) (511.79 KB - PDF)

First published: 07/04/2017Last updated: 07/04/2017
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íslenska (IS) (509.58 KB - PDF)

First published: 07/04/2017Last updated: 07/04/2017
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italiano (IT) (513.63 KB - PDF)

First published: 07/04/2017Last updated: 07/04/2017
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latviešu valoda (LV) (193.56 KB - PDF)

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lietuvių kalba (LT) (509.22 KB - PDF)

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magyar (HU) (522.74 KB - PDF)

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Malti (MT) (534.14 KB - PDF)

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Nederlands (NL) (507.42 KB - PDF)

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norsk (NO) (507.91 KB - PDF)

First published: 07/04/2017Last updated: 07/04/2017
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polski (PL) (527.71 KB - PDF)

First published: 07/04/2017Last updated: 07/04/2017
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português (PT) (508.73 KB - PDF)

First published: 07/04/2017Last updated: 07/04/2017
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română (RO) (512.04 KB - PDF)

First published: 07/04/2017Last updated: 07/04/2017
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slovenčina (SK) (525.69 KB - PDF)

First published: 07/04/2017Last updated: 07/04/2017
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slovenščina (SL) (520.52 KB - PDF)

First published: 07/04/2017Last updated: 07/04/2017
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Suomi (FI) (514.13 KB - PDF)

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svenska (SV) (508.72 KB - PDF)

First published: 07/04/2017Last updated: 07/04/2017
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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
Revision
2

Assessment history

Solymbic : EPAR - Procedural steps taken and scientific information after authorisation

English (EN) (1.46 MB - PDF)

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Solymbic : EPAR - Public assessment report

Reference Number: EMA/106921/2017

English (EN) (6.66 MB - PDF)

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CHMP summary of positive opinion for Solymbic

AdoptedReference Number: EMA/CHMP/41575/2017

English (EN) (559.71 KB - PDF)

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Related content

More information on Solymbic

Public statement on Solymbic: Withdrawal of the marketing authorisation in the European Union

Reference Number: EMA/7897/2019

English (EN) (59.31 KB - PDF)

First published:
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