Is Stavudine 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 Stavudine.

Is Stavudine approved by the US FDA?

Drugs@FDA lists 9 application product lines for Stavudine, including ZERIT (Discontinued); ZERIT (Discontinued); ZERIT XR (Discontinued); STAVUDINE (Discontinued); STAVUDINE (Discontinued).

Is Stavudine authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Stavudine.

Are there safety signals or safety updates for Stavudine?

EMA PRAC: 2 entries; US FDA: 2 entries; MHRA: 1 entry (latest 2018-12-17).

Active substance

Stavudine

SFDA 3
US FDA 9
EMA 1
Safety 5

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ZERIT 20MG CAP	20 mg	Capsule · Oral use	60 Blister	SAR 497.95	NCE · Prescription	BRISTOL-MYERS SQUIBB	Withdrawn by MAH · Not Marketed
ZERIT 30MG CAP	30 mg	Capsule · Oral use	60 Blister	SAR 689.95	NCE · Prescription	BRISTOL-MYERS SQUIBB	Withdrawn by MAH · Not Marketed
ZERIT 40MG CAP	40 mg	Capsule · Oral use	60 Blister	SAR 843.95	NCE · Prescription	BRISTOL-MYERS SQUIBB	Withdrawn by MAH · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
ZERIT	5MG; 15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	capsule · oral	BRISTOL	Discontinued	24 Jun 1994
ZERIT	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	for solution · oral	BRISTOL	Discontinued	6 Sep 1996
ZERIT XR	37.5MG; 50MG; 75MG; 100MG	capsule, extended release · oral	BRISTOL MYERS SQUIBB	Discontinued	31 Dec 2002
STAVUDINE	30MG; 40MG; 15MG; 20MG	capsule · oral	AUROBINDO PHARMA	Discontinued	29 Dec 2008
STAVUDINE	1MG/ML	for solution · oral	AUROBINDO PHARMA	Discontinued	29 Dec 2008
STAVUDINE	15MG; 20MG; 30MG; 40MG	capsule · oral	HETERO LABS LTD III	Discontinued	29 Dec 2008
STAVUDINE	15MG; 20MG; 30MG; 40MG	capsule · oral	PHARMOBEDIENT	Discontinued	29 Dec 2008
STAVUDINE	30MG; 40MG	capsule · oral	PHARMOBEDIENT	Discontinued	5 Jan 2009
STAVUDINE	1MG/ML	for solution · oral	CIPLA LTD	Discontinued	20 Mar 2009

EMA European Union — centrally authorised medicines

Zerit Bristol-Myers Squibb Pharma EEIG · Withdrawn · authorised 8 May 1996 · ATC J05AF04

Therapeutic indication (EMA)

Hard capsules Zerit is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-infected adult patients and paediatric patients (over the age of three months) only when other antiretrovirals can not be used. The duration of therapy with Zerit should be limited to the shortest time possible. Powder for oral solution Zerit is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-infected adult patients and paediatric patients (from birth) only when other antiretrovirals can not be used. The duration of therapy with Zerit should be limited to the shortest time possible.

Safety signals and safety-related labeling changes

US FDA 17 Dec 2018 ZERIT — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 17 Dec 2018 ZERIT — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; 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
MHRA 11 Dec 2014 Stavudine (Zerit): increased risk of potentially severe adverse effects
Stavudine should only be used when there are no appropriate alternatives, and for the shortest possible time.

All safety entries for stavudine →

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.