Is Maraviroc 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 Maraviroc, including CELSENTRI 150MG F.C. TABLETS (150 mg, Film-coated tablet, SAR 2861.70); CELSENTRI 300MG F.C. TABLETS (300 mg, Film-coated tablet, SAR 2861.70).

Is Maraviroc approved by the US FDA?

Drugs@FDA lists 7 application product lines for Maraviroc, including SELZENTRY (Prescription); SELZENTRY (Prescription); MARAVIROC (Prescription); MARAVIROC (Prescription); MARAVIROC (Prescription).

Is Maraviroc authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Maraviroc: Celsentri.

Are there safety signals or safety updates for Maraviroc?

EMA PRAC: 2 entries; US FDA: 2 entries (latest 2020-10-30).

Active substance

Maraviroc

SFDA 4
US FDA 7
EMA 1
Health Canada 4
US price lines 4
Safety 4

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
CELSENTRI 150MG F.C. TABLETS	150 mg	Film-coated tablet · Oral use	60 Blister	SAR 2861.70	NCE · Prescription	Glaxo Saudi Arabia Ltd.	Valid
CELSENTRI 300MG F.C. TABLETS	300 mg	Film-coated tablet · Oral use	60 Blister	SAR 2861.70	NCE · Prescription	Glaxo Saudi Arabia Ltd.	Valid
CELSENTRI 150MG F.C. TABLETS	150 mg	Film-coated tablet · Oral use	60 Blister	SAR 4255.30	NCE · Prescription	PFIZER	Withdrawn by MAH · Not Marketed
CELSENTRI 300MG F.C. TABLETS	300 mg	Film-coated tablet · Oral use	60 Blister	SAR 4255.30	NCE · Prescription	PFIZER	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

HUMAN IMMUNODEFICIENCY VIRUS

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

Product	Strength	Form · route	Applicant	Status	First approved
SELZENTRY	150MG; 300MG	tablet · oral	VIIV HLTHCARE	Prescription	6 Aug 2007
SELZENTRY	20MG/ML	solution · oral	VIIV HLTHCARE	Prescription	4 Nov 2016
MARAVIROC	150MG; 300MG	tablet · oral	HETERO LABS LTD III	Prescription	7 Feb 2022
MARAVIROC	150MG; 300MG	tablet · oral	PHARMAZONE	Prescription	17 Aug 2023
MARAVIROC	150MG; 300MG	tablet · oral	NAVINTA LLC	Prescription	13 May 2025
MARAVIROC	150MG; 300MG	tablet · oral	RHODES PHARMS	Prescription	4 Nov 2025
SELZENTRY	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	VIIV HLTHCARE	Discontinued	6 Aug 2007

EMA European Union — centrally authorised medicines

Celsentri ViiV Healthcare B.V. · Authorised · authorised 18 Sep 2007 · ATC J05AX09

Therapeutic indication (EMA)

Celsentri, in combination with other antiretroviral medicinal products, is indicated for treatment experienced adults, adolescents and children of 2 years of age and older and weighing at least 10 kg infected with only CCR5-tropic HIV-1 detectable

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
CELSENTRI	02299844	150 MG	TABLET · ORAL	VIIV HEALTHCARE ULC
CELSENTRI	02299852	300 MG	TABLET · ORAL	VIIV HEALTHCARE ULC
WAYMADE-MARAVIROC	02561921	150 MG	TABLET · ORAL	WAYMADE CANADA INC.
WAYMADE-MARAVIROC	02561948	300 MG	TABLET · ORAL	WAYMADE CANADA INC.

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	MARAVIROC 150 MG TABLET	$9.14963	per EA	19 Nov 2025
US NADAC	MARAVIROC 300 MG TABLET	$6.33913	per EA	23 Sep 2026
US NADAC	SELZENTRY 150 MG TABLET	$28.0158	per EA	17 Jun 2026
US NADAC	SELZENTRY 300 MG TABLET	$28.13113	per EA	17 Jun 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.

Safety signals and safety-related labeling changes

US FDA 30 Oct 2020 SELZENTRY — 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 30 Oct 2020 SELZENTRY — safety-related labeling change
Labeling sections changed: Adverse Reactions; Drug Interactions; Use in Specific Populations; 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

All safety entries for maraviroc →

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.