EMA — authorised 15 September 2018
- Application: EMEA/H/C/004262
- Marketing authorisation holder: Mylan S.A.S
- Local brand name: Fulphila
- Indication: Reducing neutropenia in patients taking cancer treatments
- Pathway: biosimilar
- Status: withdrawn
🇪🇺 FULPHILA in European Union
EMA authorised FULPHILA on 15 September 2018
Marketing authorisations
EMA — authorised 20 November 2018
- Application: EMEA/H/C/004915
- Marketing authorisation holder: Biosimilar Collaborations Ireland Limited
- Local brand name: Fulphila
- 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
FULPHILA 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 FULPHILA approved in European Union?
Yes. EMA authorised it on 15 September 2018; EMA authorised it on 20 November 2018.
Who is the marketing authorisation holder for FULPHILA in European Union?
Mylan S.A.S holds the EU marketing authorisation.