Zessly
infliximab
Table of contents
Overview
Zessly is an anti-inflammatory medicine for treating the following diseases:
- rheumatoid arthritis (disease causing inflammation of the joints);
- Crohn’s disease (disease causing inflammation of the gut);
- ulcerative colitis (inflammation and ulcers in the lining of the gut);
- ankylosing spondylitis (inflammation of spine causing back pain);
- psoriasis (red, scaly patches on the skin);
- psoriatic arthritis (psoriasis with inflammation of the joints).
Zessly is used mainly in adults, usually when other medicines or treatments have failed or cannot be used. For Crohn’s disease and ulcerative colitis, it is also used in children from 6 years of age. For some conditions, Zessly is also used in combination with another medicine, methotrexate.
Zessly is a ‘biosimilar medicine’. This means that it is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Zessly is Remicade. For more information on biosimilar medicines, see 'Related content' below.
Authorisation details
Product details | |
---|---|
Name |
Zessly
|
Agency product number |
EMEA/H/C/004647
|
Active substance |
infliximab
|
International non-proprietary name (INN) or common name |
infliximab
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
L04AB02
|
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 | |
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Marketing-authorisation holder |
Sandoz GmbH
|
Revision |
6
|
Date of issue of marketing authorisation valid throughout the European Union |
18/05/2018
|
Contact address |
Product information
09/10/2020 Zessly - EMEA/H/C/004647 - IAIN/0017
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
Treatment of rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis.