EU-RMPs: Removal of three important risks - Tivicay, Dovato, Juluca, Triumeq

This was an application for a variation following a worksharing procedure according to Article 20 of Commission Regulation (EC) No 1234/2008.

Following the finalisation of procedure EMEA/H/C/WS1810 concerning submission of EuroSIDA (category 3 PASS) study, this Type II worksharing variation was proposed to address the removal of three important risks (Dolutegravir Hypersensitivity reactions, Hepatobiliary reactions and Serious rash) from all four dolutegravir-containing product EU-RMPs; Tivicay (dolutegravir), Triumeq (dolutegravir/abacavir/lamivudine), Dovato (dolutegravir/lamivudine) and Juluca (dolutegravir/rilpivirine) - i.e. deletion of safety concerns. In addition, the MAH took opportunity to propose a harmonisation of the risks across all four dolutegravir-containing product EU-RMPs and other minor updates (including study details and epidemiology data). The requested worksharing procedure proposed amendments to the Risk Management Plan (RMP).