European Commission Approves Extension of Symtuza Marketing Authorisation for Paediatric Patients Aged 6 Years and Older
On 25 June 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Symtuza. The marketing authorisation holder for this medicinal product is Janssen-Cilag International N.V.
The CHMP adopted an extension to the existing indication, associated with a new strength (675 mg / 150 mg / 200 mg / 10 mg film-coated tablets), as follows:
Symtuza is indicated for the treatment of human immunodeficiency virus type 1 (HIV 1) infection in adults and paediatric patients aged 6 years and older with body weight at least 25 kg.he
European Commission (EC) officially approved an extension of the marketing authorisation for Symtuza on September 3, 2026.
Additional information to the following link: https://www.ema.europa.eu/en/medicines/human/variation/symtuza