Product class: Authorized package
Medicinal product class: For human use
Package code: 1644904
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: 150RÜ 0.25ml
Amount in package: 0.25ml 1TK
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
Labelling:  
Last imported to Estonia: 16 October 2023
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 
Percent Valid from Valid until Valid Diagnosis Doctor's speciality Primary Age Other
100  05/04/2024     Yes  N97.0-N97.9; Z31.0-Z31.9    No  until 4 years  kehavälise viljastamise ja embrüo siirdamise tervishoiuteenuste osutamise ettevalmistuseks 
50  05/04/2024     Yes      No      
100  05/04/2024     Yes  N97.0-N97.9; Z31.0-Z31.9    No  until 41 years  kehavälise viljastamise ja embrüo siirdamise tervishoiuteenuste osutamise ettevalmistuseks 
100  05/04/2024     Yes      No  until 4 years   
Reference price: 36.74 EUR 
Under reference price: No 
Reference price of daily dose: 18.37 EUR 
Entry/Changing date: 08 February 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription