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follitropin alfa (Bemfola®)


Reference No. 2088

Publication date:
29/01/2015


Appraisal information

follitropin alfa (Bemfola®) 75 IU/0.125 ml solution for injection
follitropin alfa (Bemfola®) 150 IU/0.25 ml solution for injection
follitropin alfa (Bemfola®) 225 IU/0.375 ml solution for injection
follitropin alfa (Bemfola®) 300 IU/0.50 ml solution for injection
follitropin alfa (Bemfola®) 450 IU/0.75 ml solution for injection


Company: Finox Biotech
BNF category: Endocrine system
NMG meeting date: 19/11/2014
AWMSG meeting date: 17/12/2014
   
   
Submission Type: Full Submission
Status: Recommended
Advice No: 4114
Ministerial ratification: 28/01/2015

Current Progress


Submission
received
NMG
meeting
AWMSG
meeting
Ministerial
Ratification

AWMSG advice

Follitropin alfa (Bemfola®) is recommended as an option for use within NHS Wales for the following licensed indications: • Anovulation (including polycystic ovarian disease, PCOD) in women who have been unresponsive to treatment with clomiphene citrate; • Stimulation of multifollicular development in women undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer (GIFT) and zygote intra-fallopian transfer (ZIFT); • In association with a luteinising hormone (LH) preparation for the stimulation of follicular development in women with severe LH and FSH deficiency. In clinical trials these patient were defined by an endogenous serum LH level < 1.2 IU/l; • Stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human Chorionic Gonadotropin (hCG) therapy.
Final Appraisal Recommendation (FAR)
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AWMSG Secretariat Appraisal Report (ASAR)
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Clinical Expert (CE) Summary
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