Is Daclatasvir registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Daclatasvir, including LEVERA 60 mg film-coated tablet (60 mg, Film-coated tablet, SAR 5600.00).

Is Daclatasvir approved by the US FDA?

Drugs@FDA lists 1 application product line for Daclatasvir, including DAKLINZA (Discontinued).

Is Daclatasvir authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Daclatasvir.

Is Daclatasvir on the WHO Model List of Essential Medicines?

Yes — 6.4.4.2.1. Medicines for hepatitis C > Pangenotypic direct-acting antiviral combinations (core list): Chronic hepatitis C.

Are there safety signals or safety updates for Daclatasvir?

EMA PRAC: 4 entries; US FDA: 1 entry (latest 2019-10-16).

Active substance

Daclatasvir

SFDA 3
US FDA 1
EMA 1
WHO EML 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
LEVERA 60 mg film-coated tablet	60 mg	Film-coated tablet · Oral use	28 Blister	SAR 5600.00	Generic · Prescription	SPIMACO ADDWAEIH	Valid
DAKLINZA 60 mg film-coated tablet	60 mg	Film-coated tablet · Oral use	28 Blister	SAR 41564.80	NCE · Prescription	BRISTOL-MYERS SQUIBB	Withdrawn by MAH · Not Marketed
LEVERA 30 mg film-coated tablet	30 mg	Film-coated tablet · Oral use	28 Blister	SAR 2800.00	Generic · Prescription	SPIMACO ADDWAEIH	Withdrawn by MAH · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
DAKLINZA	EQ 30MG BASE; EQ 60MG BASE; EQ 90MG BASE	tablet · oral	BRISTOL-MYERS SQUIBB	Discontinued	24 Jul 2015

EMA European Union — centrally authorised medicines

Daklinza Bristol-Myers Squibb Pharma EEIG · Expired · authorised 22 Aug 2014 · ATC J05AP07

Therapeutic indication (EMA)

Daklinza is indicated in combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infection in adults (see sections 4.2, 4.4 and 5.1). For HCV genotype specific activity, see sections 4.4 and 5.1.

WHO WHO Model List of Essential Medicines (2025)

6.4.4.2.1. Medicines for hepatitis C > Pangenotypic direct-acting antiviral combinations · core
Chronic hepatitis C
Oral > Solid > tablet: 30 mg (as dihydrochloride); 60 mg (as dihydrochloride)

Safety signals and safety-related labeling changes

US FDA 16 Oct 2019 DAKLINZA — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 2 Sep 2016 PRAC signal: Drug interaction between direct-acting antivirals (DAAV) and vitamin K antagonists leading to a reduced international normalized ratio (INR)
Action for MAH: update of the product information: Yes
EMA PRAC 9 Jun 2016 PRAC signal: Drug interaction with fluindione leading to a reduced international normalized ratio (INR)
Action for MAH: update of the product information: No
EMA PRAC 10 Apr 2015 PRAC signal: Arrhythmia
Action for MAH: update of the product information: Yes
EMA PRAC 9 Jan 2015 PRAC signal: Arrhythmia
Action for MAH: update of the product information: No

All safety entries for daclatasvir →

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.