Active substance
Ombitasvir paritaprevir ritonavir
- Safety 8
Safety signals and safety-related labeling changes
- EMA PRAC 29 Nov 2018 PRAC signal: Interstitial lung disease
Action for MAH: update of the product information: No - EMA PRAC 12 Jul 2018 PRAC signal: Interstitial lung disease
Action for MAH: update of the product information: No - EMA PRAC 12 Jul 2018 PRAC signal: Interaction possibly leading to decreased levothyroxine efficacy and hypothyroidism
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 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
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.