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Community register of medicinal products for human use


Product information

Invented name: Bemfola   
Auth. number : EU/1/13/909
Active substance : follitropin alfa
ATC: Anatomical main group: G - Genito urinary system and sex hormones
Therapeutic subgroup: G03 - Sex hormones and modulators of the genital system
Pharmacological subgroup: G03G - Gonadotropins and other ovulation stimulants
Chemical subgroup: G03GA - Gonadotropins
Chemical substance: G03GA05 - follitropin alfa
(See WHO ATC Index)
Indication: In adult women
- Anovulation (including polycystic ovarian disease, PCOD) in women who have been unresponsive to treatment with clomiphene citrate.
- Stimulation of multifollicular development in patients undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer (GIFT) and zygote intra-fallopian transfer (ZIFT).
- Follitropin alfa in association with a luteinising hormone (LH) preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency. In clinical trials these patients were defined by an endogenous serum LH level < 1.2 IU/l.

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 Gonadotrophin (hCG) therapy.
Marketing Authorisation Holder: Gedeon Richter Plc.
Gyömrői út 19-21., 1103 Budapest, Magyarország
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
31/03/2014 Centralised - Authorisation EMEA/H/C/2615 (2014)2157 of 27/03/2014
12/08/2014 Centralised - Variation EMEA/H/C/2615/IB/1/G
Updated with Decision(2015)4684 of 03/07/2015
08/07/2015 Centralised - Yearly update (2015)4684 of 03/07/2015
04/11/2015 Centralised - Notification EMEA/H/C/2615/N/7
Updated with Decision(2016)7680 of 21/11/2016
23/11/2016 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2615/T/10 (2016)7680 of 21/11/2016
23/06/2017 Centralised - Variation EMEA/H/C/2615/IAin/12
09/08/2017 Centralised - Variation EMEA/H/C/2615/IB/13
20/10/2017 Centralised - Variation EMEA/H/C/2615/IA/14