🇺🇸 Simulect in United States

FDA authorised Simulect on 12 May 1998

Marketing authorisations

FDA — authorised 12 May 1998

  • Application: BLA103764
  • Marketing authorisation holder: NOVARTIS
  • Status: supplemented

FDA

  • Status: approved

Simulect in other countries

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

Other Nephrology approved in United States

Frequently asked questions

Is Simulect approved in United States?

Yes. FDA authorised it on 12 May 1998; FDA has authorised it.

Who is the marketing authorisation holder for Simulect in United States?

NOVARTIS holds the US marketing authorisation.