FDA — authorised 28 June 2019
- Application: BLA761074
- Marketing authorisation holder: MYLAN GMBH
- Indication: Labeling
- Status: approved
🇺🇸 OGIVRI in United States
FDA authorised OGIVRI on 28 June 2019
Marketing authorisation
OGIVRI 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 United States
Frequently asked questions
Is OGIVRI approved in United States?
Yes. FDA authorised it on 28 June 2019.
Who is the marketing authorisation holder for OGIVRI in United States?
MYLAN GMBH holds the US marketing authorisation.