🇪🇺 CT-P13 in European Union

EMA authorised CT-P13 on 10 September 2013

Marketing authorisation

EMA — authorised 10 September 2013

  • Application: EMEA/H/C/002778
  • Marketing authorisation holder: Pfizer Europe MA EEIG
  • Local brand name: Inflectra
  • 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 Infl
  • Pathway: biosimilar
  • Status: approved

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CT-P13 in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Immunology / Rheumatology approved in European Union

Frequently asked questions

Is CT-P13 approved in European Union?

Yes. EMA authorised it on 10 September 2013.

Who is the marketing authorisation holder for CT-P13 in European Union?

Pfizer Europe MA EEIG holds the EU marketing authorisation.