🇪🇺 CYLTEZO in European Union

EMA authorised CYLTEZO on 10 November 2017

Marketing authorisation

EMA — authorised 10 November 2017

  • Application: EMEA/H/C/004319
  • Marketing authorisation holder: Boehringer Ingelheim International GmbH
  • Local brand name: Cyltezo
  • Indication: Please refer to section 4.1 of the Summary of product characteristics in the product information document.
  • Pathway: biosimilar
  • Status: withdrawn

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CYLTEZO in other countries

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

Other Oncology approved in European Union

Frequently asked questions

Is CYLTEZO approved in European Union?

Yes. EMA authorised it on 10 November 2017.

Who is the marketing authorisation holder for CYLTEZO in European Union?

Boehringer Ingelheim International GmbH holds the EU marketing authorisation.