EMA — authorised 14 February 2022
- Marketing authorisation holder: GLOBAL BLOOD THERAPEUTICS NETHERLANDS B. V.
- Status: approved
🇪🇺 Oxbryta in European Union
EMA authorised Oxbryta on 14 February 2022
Marketing authorisations
EMA — authorised 14 February 2022
- Application: EMEA/H/C/004869
- Marketing authorisation holder: Pfizer Europe MA EEIG
- Local brand name: Oxbryta
- Indication: Oxbryta is indicated for the treatment of haemolytic anaemia due to sickle cell disease (SCD) in adults and paediatric patients 12 years of age and older as monotherapy or in combination with hydroxycarbamide.
- Pathway: orphan, PRIME
- Status: suspended
Oxbryta in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Hematology approved in European Union
Frequently asked questions
Is Oxbryta approved in European Union?
Yes. EMA authorised it on 14 February 2022; EMA authorised it on 14 February 2022.
Who is the marketing authorisation holder for Oxbryta in European Union?
GLOBAL BLOOD THERAPEUTICS NETHERLANDS B. V. holds the EU marketing authorisation.