Is Follitropin beta registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Follitropin beta, including PUREGON 300I.U CARTRIDGE (300 IU, Solution for injection, SAR 573.05); PUREGON 600 I.U CARTRIDGE (600 IU, Solution for injection, SAR 884.40).

Is Follitropin beta authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Follitropin beta: Puregon.

Active substance

Follitropin beta

SFDA 10
EMA 2
Health Canada 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
PUREGON 300I.U CARTRIDGE	300 IU	Solution for injection · Subcutaneous use	1 Cartridge	SAR 573.05	Biological · Prescription	N.V. Organon	Valid
PUREGON 600 I.U CARTRIDGE	600 IU	Solution for injection · Subcutaneous use	1 Cartridge	SAR 884.40	Biological · Prescription	N.V. Organon	Valid
PUREGON 100 I.U AMP + SOLV	100 IU	Solution for injection · Subcutaneous use	5 Vial	SAR 1026.70	Biological · Prescription	ORGANON	Withdrawn by MAH · Not Marketed
PUREGON 100 I.U AMP + SOLV	100 IU	Solution for injection · Subcutaneous use	1 Ampoule	SAR 193.15	Biological · Prescription	ORGANON	Withdrawn by MAH · Not Marketed
PUREGON 100IU VIAL	100 IU	Solution for injection · Subcutaneous use	5 Vial	SAR 923.75	Biological · Prescription	ORGANON	Withdrawn by MAH · Not Marketed
PUREGON 100IU VIAL	100 IU	Solution for injection · Subcutaneous use	1 Vial	SAR 193.15	Biological · Prescription	ORGANON	Withdrawn by MAH · Not Marketed
PUREGON 50 I.U AMP +SOLVENT	50 IU	Solution for injection · Subcutaneous use	5 Vial	SAR 513.35	Biological · Prescription	ORGANON	Withdrawn by MAH · Not Marketed
PUREGON 50 I.U AMP +SOLVENT	50 IU	Solution for injection · Subcutaneous use	1 Ampoule	SAR 96.55	Biological · Prescription	ORGANON	Withdrawn by MAH · Not Marketed
PUREGON 50IU VIAL	50 IU	Solution for injection · Subcutaneous use	5 Vial	SAR 477.55	Biological · Prescription	ORGANON	Withdrawn by MAH · Not Marketed
PUREGON 50IU VIAL	50 IU	Solution for injection · Subcutaneous use	1 Vial	SAR 99.85	Biological · Prescription	ORGANON	Withdrawn by MAH · Not Marketed

EMA European Union — centrally authorised medicines

Puregon Organon N.V. · Authorised · authorised 2 May 1996 · ATC G03GA06

Therapeutic indication (EMA)

In the female: Puregon is indicated for the treatment of female infertility in the following clinical situations: anovulation (including polycystic ovarian syndrome, PCOS) in women who have been unresponsive to treatment with clomifene citrate; controlled ovarian hyperstimulation to induce the development of multiple follicles in medically assisted reproduction programs (e.g. in-vitro fertilisation / embryo transfer (IVF/ET), gamete intrafallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI)). In the male: Deficient spermatogenesis due to hypogonadotrophic hypogonadism.

Fertavid Merck Sharp & Dohme B.V. · Withdrawn · authorised 19 Mar 2009 · ATC G03GA06

Therapeutic indication (EMA)

In the female: Fertavid is indicated for the treatment of female infertility in the following clinical situations: Anovulation (including polycystic ovarian disease, PCOD) in women who have been unresponsive to treatment with clomifene citrate Controlled ovarian hyperstimulation to induce the development of multiple follicles in medically assisted reproduction programs [e.g. in vitro fertilisation/embryo transfer (IVF/ET), gamete intra-fallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI). In the male: Deficient spermatogenesis due to hypogonadotrophic hypogonadism.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
PUREGON	02243948	833 UNIT / ML	SOLUTION · SUBCUTANEOUS	ORGANON CANADA INC.

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.