Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: BEMFOLA
Active substances:
Follitropin alfa
Estonian, English, Latin
ATC code: G03GA05
Dosage form: solution for injection in pre-filled pen
Strength: 300RÜ 0.5ml
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
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
Marketing authorization holder: Gedeon Richter Plc. 
Marketing authorization number: EU/1/13/909 
Marketing authorization issued on: March 31, 2014 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1644926  BEMFOLA  solution for injection in pre-filled pen  300RÜ 0.5ml 0.5ml 1TK  Prescription  100% 50%  73,48  13.05.2024     
1683301  BEMFOLA  solution for injection in pre-filled pen  300RÜ 0.5ml 0.5ml 5TK  Prescription           
1683312  BEMFOLA  solution for injection in pre-filled pen  300RÜ 0.5ml 0.5ml 10TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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