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AUTHORISED  

Product information

Invented name: Inflectra   
Auth. number : EU/1/13/854
INN : Infliximab
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L04 - Immunosuppressive agents
Pharmacological subgroup: L04A - Immunosuppressive agents
Chemical subgroup: L04AB - Tumor necrosis factor alpha (TNF-a) inhibitors
Chemical substance: L04AB02 - Infliximab
(See WHO ATC Index)
Indication: Rheumatoid arthritis
Inflectra, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in:
• adult patients with active disease when the response to disease modifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate.
• adult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs.
In these patient populations, a reduction in the rate of the progression of joint damage, as measured by X ray, has been demonstrated.
Adult Crohn’s disease
Inflectra 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.
• treatment of fistulising, active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy).
Paediatric Crohn’s disease
Inflectra is indicated for treatment of severe, active Crohn’s disease in children and adolescents aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies. Infliximab has been studied only in combination with conventional immunosuppressive therapy.
Ulcerative colitis
Inflectra 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.
Paediatric ulcerative colitis
Inflectra is indicated for treatment of severely active ulcerative colitis in children and adolescents aged 6 to 17 years, who have had an inadequate response to conventional therapy including corticosteroids and 6 MP or AZA, or who are intolerant to or have medical contraindications for such therapies.
Ankylosing spondylitis
Inflectra is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.
Psoriatic arthritis
Inflectra is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate.
Inflectra should be administered
• in combination with methotrexate
• or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated.
Infliximab 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.
Psoriasis
Inflectra is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen ultra-violet A (PUVA)
Marketing Authorisation Holder: Hospira UK Limited
Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
12/09/2013 Centralised - Authorisation EMEA/H/C/2778 (2013)5887 of 10/09/2013
11/10/2013 Centralised - Variation EMEA/H/C/2778/IA/1
Updated with Decision(2014)7150 of 30/09/2014
16/12/2013 Centralised - Variation EMEA/H/C/2778/IB/4
Updated with Decision(2014)7150 of 30/09/2014
17/03/2014 Centralised - Variation EMEA/H/C/2778/IB/10
Updated with Decision(2014)7150 of 30/09/2014
17/06/2014 Centralised - Variation EMEA/H/C/2778/IB/11
Updated with Decision(2014)7150 of 30/09/2014
10/07/2014 Centralised - Variation EMEA/H/C/2778/IB/13
Updated with Decision(2014)7150 of 30/09/2014
25/09/2014 Centralised - Variation EMEA/H/C/2778/IA/14/G
02/10/2014 Centralised - Yearly update (2014)7150 of 30/09/2014