This medicine is authorised for use in the European Union.


Erelzi is an anti-inflammatory medicine for treating the following immune system diseases:

  • rheumatoid arthritis (a disease causing inflammation of the joints), used with another medicine, methotrexate, or alone;
  • certain forms of juvenile idiopathic arthritis (diseases causing inflammation in the joints);
  • plaque psoriasis (a disease causing red, scaly patches on the skin);
  • psoriatic arthritis (psoriasis with inflammation of the joints);
  • axial spondyloarthritis (inflammation of the spine causing back pain), including ankylosing spondylitis and non-radiographic axial spondyloarthritis which is when there are clear signs of inflammation but X-ray does not show disease.

Erelzi is mostly used when these conditions are severe or moderately severe, or when other treatments have not worked well enough or cannot be used. For detailed information on the use of Erelzi in all conditions, see the package leaflet or contact your doctor or pharmacist.

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

This EPAR was last updated on 04/08/2023

Authorisation details

Product details
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
  • Arthritis, Psoriatic
  • Psoriasis
  • Arthritis, Juvenile Rheumatoid
  • Arthritis, Rheumatoid
  • Spondylitis, Ankylosing
Anatomical therapeutic chemical (ATC) code

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
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Biochemiestrasse 10
6250 Kundl

Product information

01/08/2023 Erelzi - EMEA/H/C/004192 - IAIN/0049/G

Other EU languages available icon 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:

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.

Pharmacotherapeutic group


Therapeutic indication

Rheumatoid arthritis

Erelzi in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease‑modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate.

Erelzi can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.

Erelzi is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.

Etanercept, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X‑ray and to improve physical function.

Juvenile idiopathic arthritis

Treatment of polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.

Treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.

Treatment of enthesitis‑related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy.

Etanercept has not been studied in children aged less than 2 years.

Psoriatic arthritis

Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease‑modifying antirheumatic drug therapy has been inadequate. Etanercept has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X‑ray in patients with polyarticular symmetrical subtypes of the disease.

Axial spondyloarthritis

Ankylosing spondylitis (AS)

Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.

Non‑radiographic axial spondyloarthritis

Treatment of adults with severe non‑radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C‑reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to non‑steroidal anti‑inflammatory drugs (NSAIDs).

Plaque psoriasis

Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy, including ciclosporin, methotrexate or psoralen and ultraviolet‑A light (PUVA).

Paediatric plaque psoriasis

Treatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.

Assessment history

How useful was this page?

Add your rating
1 rating
1 rating
1 rating