Solymbic
adalimumab
Table of contents
Overview
The marketing authorisation for Solymbic has been withdrawn at the request of the marketing-authorisation holder.
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) |
|
| 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 | |
Product information
22/06/2018 Solymbic - EMEA/H/C/004373 - IG/0946
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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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.