Zessly

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infliximab

Authorised
This medicine is authorised for use in the European Union.

Overview

An overview of Zessly and why it is authorised in the EU

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.

Zessly contains the active substance infliximab.

This EPAR was last updated on 12/11/2018

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)
  • Arthritis, Psoriatic
  • Psoriasis
  • Crohn Disease
  • Arthritis, Rheumatoid
  • Colitis, Ulcerative
  • Spondylitis, Ankylosing
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
Marketing-authorisation holder
Sandoz GmbH
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
18/05/2018
Contact address
Biochemiestrasse 10
6250 Kundl
Austria

Product information

12/10/2018 Zessly - EMEA/H/C/004647 - IB/0002

Contents

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Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Treatment of rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis. For more information see section 5.1

Assessment history

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