Is Ritonavir registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 0 valid registrations of Ritonavir.

Is Ritonavir approved by the US FDA?

Drugs@FDA lists 12 application product lines for Ritonavir, including NORVIR (Prescription); RITONAVIR (Prescription); NORVIR (Prescription); RITONAVIR (Prescription); RITONAVIR (Prescription).

Is Ritonavir authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Ritonavir: Norvir, Ritonavir Viatris (previously Ritonavir Mylan).

Is Ritonavir on the WHO Model List of Essential Medicines?

Yes — 6.4.2.3. Antiretrovirals > Protease inhibitors (core list): Human immunodeficiency virus disease without mention of tuberculosis or malaria, clinical stage unspecified.

Are there safety signals or safety updates for Ritonavir?

EMA PRAC: 6 entries; US FDA: 11 entries (latest 2026-07-23).

Active substance

Ritonavir

SFDA 1
US FDA 12
EMA 2
Health Canada 2
US price lines 2
WHO EML 1
Safety 17

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
NORVIR 80MG-ML ORAL SOLN.	80 mg/ml	Solution · Oral use	1 Bottle	SAR 795.40	NCE · Prescription	Abbott Laboratories	Invalid · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
NORVIR	100MG	tablet · oral	ABBVIE	Prescription	10 Feb 2010
RITONAVIR	100MG	tablet · oral	CIPLA	Prescription	15 Jan 2015
NORVIR	100MG/PACKET	powder · oral	ABBVIE	Prescription	7 Jun 2017
RITONAVIR	100MG	tablet · oral	HETERO LABS LTD III	Prescription	17 Sep 2018
RITONAVIR	100MG	tablet · oral	AUROBINDO PHARMA LTD	Prescription	17 Sep 2018
RITONAVIR	100MG	tablet · oral	CIPLA	Prescription	10 May 2022
RITONAVIR	100MG	capsule · oral	QUAGEN	Prescription	16 Feb 2024
NORVIR	80MG/ML	solution · oral	ABBVIE	Discontinued	1 Mar 1996
NORVIR	100MG	capsule · oral	ABBOTT	Discontinued	1 Mar 1996
NORVIR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	capsule · oral	ABBVIE	Discontinued	29 Jun 1999
RITONAVIR	100MG	tablet · oral	AMNEAL	Discontinued	17 Sep 2018
RITONAVIR	100MG	capsule · oral	HIKMA PHARMS	Discontinued	3 Dec 2020

EMA European Union — centrally authorised medicines

Norvir AbbVie Deutschland GmbH & Co. KG · Authorised · authorised 25 Aug 1996 · ATC J05AE03

Therapeutic indication (EMA)

Ritonavir is indicated in combination with other antiretroviral agents for the treatment of HIV-1-infected patients (adults and children of two years of age and older).

Ritonavir Viatris (previously Ritonavir Mylan) Viatris Limited · Authorised · authorised 9 Nov 2017 · ATC J05AE03

Therapeutic indication (EMA)

Ritonavir is indicated as a pharmacokinetic enhancer of co-administered protease inhibitors as part of antiretroviral combination therapy in human immunodeficiency virus-1 (HIV-1) infected patients (adults and children of 2 years of age and older).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
AURO-RITONAVIR	02523620	100 MG	TABLET · ORAL	AURO PHARMA INC
NORVIR	02357593	100 MG	TABLET · ORAL	ABBVIE CORPORATION

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	NORVIR 100 MG TABLET	$8.3489	per EA	23 Sep 2026
US NADAC	RITONAVIR 100 MG TABLET	$0.60659	per EA	23 Sep 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

WHO WHO Model List of Essential Medicines (2025)

6.4.2.3. Antiretrovirals > Protease inhibitors · core
Human immunodeficiency virus disease without mention of tuberculosis or malaria, clinical stage unspecified
Oral > Solid: 25 mg tablet (heat stable); 100 mg tablet (heat stable)

Safety signals and safety-related labeling changes

US FDA 23 Jul 2026 KALETRA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 23 Jul 2026 KALETRA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 23 Jul 2026 NORVIR — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 23 Jul 2026 NORVIR — safety-related labeling change
Labeling sections changed: Contraindications; Adverse Reactions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 11 Feb 2026 PAXLOVID (COPACKAGED) — safety-related labeling change
Labeling sections changed: Contraindications; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 21 Oct 2020 KALETRA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 21 Oct 2020 NORVIR — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 21 Oct 2020 NORVIR — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 6 Dec 2019 TECHNIVIE — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 6 Dec 2019 VIEKIRA PAK (COPACKAGED) — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 6 Dec 2019 VIEKIRA XR — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; 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
EMA PRAC 8 Feb 2018 PRAC signal: Interaction possibly leading to decreased levothyroxine efficacy and hypothyroidism
Action for MAH: update of the product information: Yes
EMA PRAC 30 Nov 2017 PRAC signal: Interaction possibly leading to decreased levothyroxine efficacy and hypothyroidism
Action for MAH: update of the product information: No

All safety entries for ritonavir →

Combinations containing Ritonavir

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.