Is Follitropin alfa + Lutropin alfa registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 3 valid registrations of Follitropin alfa + Lutropin alfa, including PERGOVERIS 150/75 IU vial (150,75 IU,IU, Solution for injection, SAR 230.25); Pergoveris (300,150 IU,IU, Solution for injection in pre-filled pen, SAR 607.80); Pergoveris (450,225 IU,IU, Solution for injection in pre-filled pen, SAR 911.65).

Is Follitropin alfa + Lutropin alfa authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Follitropin alfa + Lutropin alfa: Pergoveris.

Active substances

Follitropin alfa + Lutropin alfa

SFDA 3
EMA 1
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
PERGOVERIS 150/75 IU vial	150,75 IU,IU	Solution for injection · Subcutaneous use	1 Vial	SAR 230.25	Biological · Prescription	Merck (Schweiz) AG	Valid
Pergoveris	300,150 IU,IU	Solution for injection in pre-filled pen · Subcutaneous use	1 Pre-filled pen	SAR 607.80	Biological · Prescription	Merck Europe BV	Valid
Pergoveris	450,225 IU,IU	Solution for injection in pre-filled pen · Subcutaneous use	1 Pre-filled pen	SAR 911.65	Biological · Prescription	Merck Europe BV	Valid

EMA European Union — centrally authorised medicines

Pergoveris Merck Europe B.V. · Authorised · authorised 25 Jun 2007 · ATC G03GA30

Therapeutic indication (EMA)

Pergoveris is indicated for the stimulation of follicular development in women with severe luteinising-hormone (LH) and follicle-stimulating-hormone deficiency. In clinical trials, these patients were defined by an endogenous serum LH level < 1.2 IU/l.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
PERGOVERIS	02470640	300 UNIT / 0.48 ML; 150 UNIT / 0.48 ML	SOLUTION · SUBCUTANEOUS	EMD SERONO, A DIVISION OF EMD INC., CANADA
PERGOVERIS	02470659	225 UNIT / 0.72 ML; 450 UNIT / 0.72 ML	SOLUTION · SUBCUTANEOUS	EMD SERONO, A DIVISION OF EMD INC., CANADA
PERGOVERIS	02470667	900 UNIT / 1.44 ML; 450 UNIT / 1.44 ML	SOLUTION · SUBCUTANEOUS	EMD SERONO, A DIVISION OF EMD INC., CANADA

Components

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.