Table of contents
The marketing authorisation for Cyltezo has been withdrawn at the request of the marketing-authorisation holder.
Cyltezo : EPAR - Summary for the public (PDF/228.67 KB)
First published: 17/11/2017
Last updated: 17/11/2017
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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.
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.
Boehringer Ingelheim International GmbH
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Binger Strasse 173 55216
Ingelheim am Rhein
15/01/2019 Cyltezo - EMEA/H/C/004319 - IB/0005/G
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.
Please refer to section 4.1 of the Summary of product characteristics in the product information document.