🇪🇸 Nizoral in Spain

Nizoral (ketoconazole) regulatory status in Spain.

Marketing authorisation

AEMPS

  • 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 Spain

Frequently asked questions

Is Nizoral approved in Spain?

Yes. AEMPS has authorised it.

Who is the marketing authorisation holder for Nizoral in Spain?

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