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The marketing authorisation for Solymbic has been withdrawn at the request of the marketing-authorisation holder.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 |
Minervum 7061
4817 ZK Breda Netherlands |
Product information
22/06/2018 Solymbic - EMEA/H/C/004373 - IG/0946
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.
Pharmacotherapeutic group
Immunosuppressants
Therapeutic indication
Please refer to section 4.1 of the Summary of product characteristics in the product information document.