EMA — authorised 22 August 2002
- Marketing authorisation holder: Amgen Europe B.V.
- Status: approved
🇪🇺 Neulasta in European Union
EMA authorised Neulasta on 22 August 2002
Marketing authorisations
EMA — authorised 18 November 2020
- Application: EMEA/H/C/005085
- Marketing authorisation holder: Pfizer Europe MA EEIG
- Local brand name: Nyvepria
- Indication: Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
- Pathway: biosimilar
- Status: approved
Neulasta 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 Neulasta approved in European Union?
Yes. EMA authorised it on 22 August 2002; EMA authorised it on 18 November 2020.
Who is the marketing authorisation holder for Neulasta in European Union?
Amgen Europe B.V. holds the EU marketing authorisation.