- Current languageen
Pharmaceuticals - Community Register
Community register of medicinal products for human use
|Auth. number :||EU/1/13/854|
|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)
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.
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
|Marketing Authorisation Holder:||Hospira UK Limited
Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom
The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
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 continues to be available in the Community Register.
|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|
|16/12/2013||Centralised - Variation||EMEA/H/C/2778/IB/4|