🇪🇺 Herceptin in European Union

EMA authorised Herceptin on 28 August 2000

Marketing authorisations

EMA — authorised 28 August 2000

  • Marketing authorisation holder: ROCHE REGISTRATION GMBH
  • Local brand name: Herceptin
  • Status: approved

EMA

  • Application: EMEA/H/C/000278
  • Local brand name: Herceptin
  • Status: approved

Herceptin 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 Herceptin approved in European Union?

Yes. EMA authorised it on 28 August 2000; EMA has authorised it.

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

ROCHE REGISTRATION GMBH holds the EU marketing authorisation.