Bemfola
Follitropin alfa biosimilar developed by Finox Biotech. Reference product Gonal-f.
Brands by market: Bemfola (EU, UAE) · Commercial partner or holder: Gedeon Richter (EU, UAE)
FDAnot listed
EMAMar 2014authorised
PMDAnot listed
HCnot listed
CDSCOnot listed
EDESep 2016registered
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union · Bemfola
European Medicines Agency and European CommissionApprovedBrand
Bemfola
Holder or applicant
Gedeon Richter Plc.
Pathway
Centralised (Article 10(4))
Approved
Mar 2014
Application or permission
EMEA/H/C/002615
Indications as licensed
Anovulation, controlled ovarian stimulation, LH/FSH deficiency, male hypogonadotropic hypogonadism
Presentations
see SmPC
Source
S017
PMDA
Japan
Not listed by PMDA.
HC
Canada
Not listed by HC.
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates · Bemfola
Emirates Drug EstablishmentRegisteredBrand
Bemfola
Holder or applicant
Gedeon Richter Plc., Hungary · UAE supplier Gulf Drug LLC
Pathway
Registered medical product
Registered
Sep 2016
Presentations
75, 150, 225, 300 and 450 IU pens
Source
S018
Chronology
- EMAMar 2014Authorised by the European Commission as Bemfola
- EDESep 2016Registered in the UAE as Bemfola
Sources
S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)S018UAE Emirates Drug Establishment, registered medical product directory Primary (regulator)
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