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.
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).
Therapeutic Area (MeSH)
N/AATC Code
L03AA13
ATC Item
pegfilgrastim
Pharmacotherapeutic Group
Immunostimulants
Active Substance (Summary)
INN / Common Names
N/A| Substance | CAS | Monograph |
|---|---|---|
| pegfilgrastim | N/A | Pegfilgrastim |
EMA Name
Fulphila
Medicine Name
Fulphila
Aliases
N/ANo risk management plan link.
