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The marketing authorisation for Solymbic has been withdrawn at the request of the marketing-authorisation holder.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
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
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Pharmacotherapeutic group
Immunosuppressants
Therapeutic indication
Please refer to section 4.1 of the Summary of product characteristics in the product information document.