Is Dasabuvir 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 Dasabuvir.

Is Dasabuvir authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Dasabuvir.

Are there safety signals or safety updates for Dasabuvir?

EMA PRAC: 9 entries; US FDA: 2 entries (latest 2019-12-06).

Active substance

Dasabuvir

SFDA 1
EMA 1
Safety 11

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
EXVIERA 250 mg film-coated tablet	250 mg	Film-coated tablet · Oral use	56 Blister	SAR 6439.80	NCE · Prescription	ABBVIE	Withdrawn by MAH · Not Marketed

EMA European Union — centrally authorised medicines

Exviera AbbVie Limited · Withdrawn · authorised 14 Jan 2015 · ATC J05AP09

Therapeutic indication (EMA)

Exviera is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults. For hepatitis C virus (HCV) genotype specific activity.

Safety signals and safety-related labeling changes

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 16 May 2019 PRAC signal: Autoimmune hepatitis
Action for MAH: update of the product information: No
EMA PRAC 29 Nov 2018 PRAC signal: Interstitial lung disease
Action for MAH: update of the product information: No
EMA PRAC 4 Oct 2018 PRAC signal: Dysglycaemia
Action for MAH: update of the product information: Yes
EMA PRAC 12 Jul 2018 PRAC signal: Interstitial lung disease
Action for MAH: update of the product information: No
EMA PRAC 17 May 2018 PRAC signal: Dysglycaemia
Action for MAH: update of the product information: No
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: Depression and suicidal ideation
Action for MAH: update of the product information: No
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 14 Apr 2016 PRAC signal: Unexpected early hepatocellular carcinoma recurrence
Action for MAH: update of the product information: No

All safety entries for dasabuvir →

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.