Kromeya

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adalimumab

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

Overview

Kromeya is a medicine that acts on the immune system (the body’s natural defences) 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 there are clear signs of inflammation but X-ray does not show disease;
  • polyarticular juvenile idiopathic arthritis and active enthesitis-related arthritis (both rare diseases causing inflammation in the joints);
  • Crohn’s disease (a disease causing inflammation of the gut);
  • ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut);
  • non-infectious uveitis (inflammation of the layer beneath the white of the eyeball).

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

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

This EPAR was last updated on 29/07/2019

Authorisation details

Product details
Name
Kromeya
Agency product number
EMEA/H/C/005158
Active substance
adalimumab
International non-proprietary name (INN) or common name
adalimumab
Therapeutic area (MeSH)
  • Arthritis, Rheumatoid
  • Arthritis, Juvenile Rheumatoid
  • Psoriasis
  • Arthritis, Psoriatic
  • Spondylitis, Ankylosing
  • Uveitis
  • Colitis, Ulcerative
  • Crohn Disease
Anatomical therapeutic chemical (ATC) code
L04AB04
Additional monitoringAdditional 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.

BiosimilarBiosimilar

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
Fresenius Kabi Deutschland GmbH
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
02/04/2019
Contact address

Else-Kröner-Straße 1,
61352 Bad Homburg v.d.Höhe
Germany

Product information

12/06/2019 Kromeya - EMEA/H/C/005158 - IAIN/0001/G

Contents

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Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Rheumatoid arthritis

Kromeya in combination with methotrexate, is indicated for:

  • the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.
  • the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.

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

Adalimumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.

Juvenile idiopathic arthritis

Polyarticular juvenile idiopathic arthritis

Kromeya in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Idacio can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). Adalimumab has not been studied in patients aged less than 2 years.

Enthesitis-related arthritis

Kromeya is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1).

Axial spondyloarthritis

Ankylosing spondylitis (AS)

Kromeya is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.

Axial spondyloarthritis without radiographic evidence of AS

Kromeya is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs.

Psoriatic arthritis

Kromeya is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate.

Adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and to improve physical function.

Psoriasis

Kromeya is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.

Paediatric plaque psoriasis

Kromeya is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies.

Crohn’s disease

Kromeya is indicated for treatment of moderately to severely active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.

Paediatric Crohn's disease

Kromeya is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies.

Ulcerative colitis

Kromeya is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6 mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.

Uveitis

Kromeya is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid- sparing, or in whom corticosteroid treatment is inappropriate.

Paediatric Uveitis

Kromeya is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

Assessment history

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