Area HIV: Minutes from the EMA’s Committee for Medicinal Products for Human Use (CHMP) meeting on 10-13 October 2022

Items of interest listed below:

Extension of Marketing Authorisation

Extension of marketing Authorisation; Day 180 list of outstanding issues

Triumeq (dolutegravir / abacavir / lamivudine) - ViiV Healthcare B.V.

• Extension application to introduce a new pharmaceutical form associated with new strength (5 mg/60 mg/30 mg dispersible tablet). The new presentation is indicated for the treatment of Human Immunodeficiency Virus (HIV) infected children weighing at least 14 kg to less than 25 kg. This extension application is grouped with a type II variation (C.I.6.a) to include treatment of children weighing at least 25 kg for the already approved film-coated tablets for Triumeq (EU/1/14/940/001-002); as a consequence, sections 4.1, 4.2, 5.1 and 5.2 of the SmPC are updated. The Package Leaflet and Labelling are updated in accordance. The RMP (version 19) is updated in accordance.

• The Committee was reminded of the status of this application and its remaining outstanding issues, concerning quality and clinical aspects and adopted a list of outstanding issues with a specific timetable

CHMP assessed procedures scope: Non-Clinical and Clinical aspects

Dovato, Juluca, Tivicay Triumeq- ViiV Healthcare B.V

• Update of section 4.6 of the SmPC in order to update information on pregnancy and breast-feeding based on supporting published medical literature data on DolPHIN-1 (Dolutegravir in pregnant HIV mothers and their neonates, NCT02245022). In addition, administrative changes were included in section 5.3 of the SmPC of Tivicay and Juluca.

• Positive Opinion adopted by consensus on 22.09.2022.