Basic Information
Fulphila
Regulatory Information
EMEA/H/C/004915
November 20, 2018
September 19, 2018
12
May 29, 2018
Company Information
Biosimilar Collaborations Ireland Limited,Unit 35/36,Grange Parade,,Baldoyle Industrial Estate,Dublin 13,DUBLIN,D13 R20R,Ireland
Ireland
Unit 35/36 Grange Parade, Baldoyle Industrial Estate Dublin 13 DUBLIN D13 R20R
biosimilar collaborations ireland limited
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic 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).
Overview Summary
On 3 August 2017, Mylan S.A.S. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Fulphila, for reducing neutropenia in patients taking cancer treatments.