Is Saquinavir approved by the US FDA?

Drugs@FDA lists 3 application product lines for Saquinavir, including INVIRASE (Discontinued); FORTOVASE (Discontinued); INVIRASE (Discontinued).

Is Saquinavir authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Saquinavir.

Are there safety signals or safety updates for Saquinavir?

EMA PRAC: 2 entries; US FDA: 2 entries; MHRA: 1 entry (latest 2019-12-19).

Active substance

Saquinavir

US FDA 3
EMA 2
Safety 5

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
INVIRASE	EQ 200MG BASE	capsule · oral	HOFFMANN LA ROCHE	Discontinued	6 Dec 1995
FORTOVASE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	capsule · oral	HOFFMANN LA ROCHE	Discontinued	7 Nov 1997
INVIRASE	EQ 500MG BASE	tablet · oral	HOFFMANN-LA ROCHE	Discontinued	17 Dec 2004

EMA European Union — centrally authorised medicines

Invirase Roche Registration GmbH · Withdrawn · authorised 3 Oct 1996 · ATC J05AE01

Therapeutic indication (EMA)

Invirase is indicated for the treatment of HIV-1-infected adult patients. Invirase should only be given in combination with ritonavir and other antiretroviral medicinal products.

Fortovase Roche Registration Ltd. · Withdrawn · authorised 20 Aug 1998 · ATC J05AE01

Therapeutic indication (EMA)

Fortovase is indicated for treatment of HIV-1 infected adult patients. Fortovase should only be given in combination with ritonavir and other antiretroviral medicinal products (see section 4.2).

Safety signals and safety-related labeling changes

US FDA 19 Dec 2019 INVIRASE — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 28 Mar 2019 INVIRASE — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 12 Jul 2018 PRAC signal: Autoimmune hepatitis
Action for MAH: update of the product information: Yes
EMA PRAC 8 Mar 2018 PRAC signal: Autoimmune hepatitis
Action for MAH: update of the product information: No
MHRA 11 Dec 2014 Saquinavir: update on potential risk of arrhythmia
Saquinavir at a reduced dose for the first week of treatment

All safety entries for saquinavir →

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.