Is Follitropin alfa registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 10 valid registrations of Follitropin alfa, including BEMFOLA 150IU/0.25ML INJECTION (150 IU, Solution for injection, SAR 168.80); BEMFOLA 225IU/0.375ML INJECTION (225 IU, Solution for injection, SAR 258.85); BEMFOLA 300IU/0.5ML INJECTION (300 IU, Solution for injection, SAR 339.55); BEMFOLA 450IU/0.75ML INJECTION (450 IU, Solution for injection, SAR 436.95); BEMFOLA 75IU/0.125ML INJECTION (75 IU, Solution for injection, SAR 86.10).

Is Follitropin alfa authorised in the European Union?

EMA lists 3 centrally authorised medicines containing Follitropin alfa: GONAL-f, Ovaleap, Bemfola.

Active substance

Follitropin alfa

SFDA 11
EMA 3
Health Canada 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
BEMFOLA 150IU/0.25ML INJECTION	150 IU	Solution for injection · Subcutaneous use	1 Pre-filled pen	SAR 168.80	Biological · Prescription	Finox Biotech AG	Valid
BEMFOLA 225IU/0.375ML INJECTION	225 IU	Solution for injection · Subcutaneous use	1 Pre-filled pen	SAR 258.85	Biological · Prescription	Finox Biotech AG	Valid
BEMFOLA 300IU/0.5ML INJECTION	300 IU	Solution for injection · Subcutaneous use	1 Pre-filled pen	SAR 339.55	Biological · Prescription	Finox Biotech AG	Valid
BEMFOLA 450IU/0.75ML INJECTION	450 IU	Solution for injection · Subcutaneous use	1 Pre-filled pen	SAR 436.95	Biological · Prescription	Finox Biotech AG	Valid
BEMFOLA 75IU/0.125ML INJECTION	75 IU	Solution for injection · Subcutaneous use	1 Pre-filled pen	SAR 86.10	Biological · Prescription	Finox Biotech AG	Valid
GONAL-F 300 IU solution for injection in pre-filled pen	300 IU	Solution for injection in pre-filled pen · Subcutaneous use	1 Pre-filled pen	SAR 363.00	Biological · Prescription	MERCK SERONO	Valid
GONAL-F 450 IU solution for injection in pre-filled pen	450 IU	Solution for injection in pre-filled pen · Subcutaneous use	1 Pre-filled pen	SAR 544.50	Biological · Prescription	MERCK SERONO	Valid
GONAL-F 75 IU AMPOULE	75 IU	Powder and solvent for solution for injection · Subcutaneous use	1 Ampoule	SAR 155.30	Biological · Prescription	SERONO	Valid
GONAL-F 900 IU solution for injection in pre-filled pen	900 IU	Solution for injection in pre-filled pen · Subcutaneous use	1 Pre-filled pen	SAR 1089.00	Biological · Prescription	MERCK SERONO	Valid
GONAL-f 150 IU per 0.25 ml	600 IU/ml	Solution for injection · Subcutaneous use	1 Pre-filled pen	SAR 189.75	Biological · Prescription	Merck Europe BV	Valid
GONAL-F 150 IU AMPOULE	150 IU	Powder and solvent for solution for injection · Subcutaneous use	1 Ampoule	SAR 243.65	Biological · Prescription	SERONO	Withdrawn by MAH · Not Marketed

EMA European Union — centrally authorised medicines

GONAL-f Merck Europe B.V. · Authorised · authorised 20 Oct 1995 · ATC G03GA05

Therapeutic indication (EMA)

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). GONAL-f 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. GONAL-f is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human chorionic gonadotrophin (hCG) therapy.

Ovaleap Theramex Ireland Limited · Authorised · authorised 27 Sep 2013 · ATC G03GA05

Therapeutic indication (EMA)

In adult women Anovulation (including polycystic ovarian syndrome) in women who have been unresponsive to treatment with clomifene 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; Ovaleap 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 Ovaleap is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotropic hypogonadism with concomitant human chorionic gonadotropin (hCG) therapy.

Bemfola Gedeon Richter Plc. · Authorised · authorised 26 Mar 2014 · ATC G03GA05

Therapeutic indication (EMA)

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.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
GONAL-F PEN	02270382	900 UNIT / 1.44 ML	SOLUTION · SUBCUTANEOUS	EMD SERONO, A DIVISION OF EMD INC., CANADA
GONAL-F PEN	02270390	450 UNIT / 0.72 ML	SOLUTION · SUBCUTANEOUS	EMD SERONO, A DIVISION OF EMD INC., CANADA
GONAL-F PEN	02270404	300 UNIT / 0.48 ML	SOLUTION · SUBCUTANEOUS	EMD SERONO, A DIVISION OF EMD INC., CANADA

Combinations containing Follitropin alfa

Follitropin alfa + lutropin alfa

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.