🇪🇺 Nizoral in European Union

Nizoral (ketoconazole) regulatory status in European Union.

Marketing authorisation

EMA

  • Application: EMEA/H/C/003906
  • Local brand name: Ketoconazole Esteve (previously Ketoconazole HRA)
  • Status: approved

Nizoral in other countries

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

Other Infectious Disease approved in European Union

Frequently asked questions

Is Nizoral approved in European Union?

Yes. EMA has authorised it.

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

Johnson & Johnson (Janssen) is the originator. The local marketing authorisation holder may differ — check the official source linked above.