Halimatoz

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adalimumab

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

Overview

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

Halimatoz is a medicine that acts on the immune system and is used to treat the following conditions:

  • plaque psoriasis (a disease causing red, scaly patches on the skin);
  • psoriatic arthritis (a disease causing red, scaly patches on the skin with inflammation of the joints);
  • rheumatoid arthritis (a disease causing inflammation of the joints);
  • axial spondyloarthritis (inflammation of the spine causing back pain), including ankylosing spondylitis and when X-ray does not show disease but there are clear signs of inflammation;
  • polyarticular juvenile idiopathic arthritis and active enthesitis-related arthritis (both rare diseases causing inflammation in the joints);
  • hidradenitis suppurativa (acne inversa), a long-term skin disease that causes lumps, abscesses (collections of pus) and scarring on the skin;
  • non-infectious uveitis (inflammation of the layer beneath the white of the eyeball).

Halimatoz is mostly used in adults when their conditions are severe, moderately severe or getting worse, or when patients cannot use other treatments. For more information on the use of Halimatoz in all conditions, including when it can be used in children, see the package leaflet or contact your doctor or pharmacist.

Halimatoz contains the active substance adalimumab and is a ‘biosimilar medicine’. This means that Halimatoz is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Halimatoz is Humira.

This EPAR was last updated on 03/12/2018

Authorisation details

Product details
Name
Halimatoz
Agency product number
EMEA/H/C/004866
Active substance
adalimumab
International non-proprietary name (INN) or common name
adalimumab
Therapeutic area (MeSH)
  • Hidradenitis Suppurativa
  • Psoriasis
  • Arthritis, Juvenile Rheumatoid
  • Uveitis
  • Arthritis, Rheumatoid
  • Spondylitis, Ankylosing
  • Arthritis, Psoriatic
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
Sandoz GmbH
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
25/07/2018
Contact address
Biochemiestrasse 10
6250 Kundl
Austria

Product information

15/10/2018 Halimatoz - EMEA/H/C/004866 - IB/0002/G

Contents

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Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Please refer to the product information document.

Assessment history

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