Product class: Authorized package
Medicinal product class: For human use
Package code: 1683301
Name of medicinal product: BEMFOLA
Active substances:
Follitropin alfa
Estonian, English, Latin
ATC code: G03GA05
Dosage form: solution for injection in pre-filled pen
Route of administration: subcutaneous use
Strengh: 300RÜ 0.5ml
Amount in package: 0.5ml 5TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: In adult women • Anovulation (including polycystic ovarian syndrome) 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 and zygote intra-fallopian transfer. • Follitropin alfa in association with a luteinising hormone (LH) preparation is indicated for the stimulation of follicular development in women with severe LH and FSH deficiency. In adult men • Follitropin alfa is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human chorionic gonadotropin (hCG) therapy.
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Gedeon Richter Plc. 
Marketing authorization number: EU/1/13/909 
Marketing authorization issued on: 31 March 2014 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: 08 February 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription