Swissmedic marketing authorisation number: 67426
Swissmedic marketing authorisation date: 19/02/2020
Xofluza® 2 mg/ml granules for oral suspension
Swissmedic marketing authorisation number: 68068
Swissmedic marketing authorisation date: 19/11/2021
1.
Indication: influenza
Phase: III
Summary: Randomised, double-blind, multi-centre, placebo- and active-controlled study to assess the efficacy and safety of a single oral dose of Xofluza in comparison with placebo or oseltamivir in otherwise healthy adult and adolescent (aged ≥12 to ≤64, who weighed at least 40 kg) influenza patients.
Sponsors: Shionogi & Co., Ltd (for Japan/Asia), Shionogi Inc. (USA), Shionogi Ltd. (Australia, New Zealand, South Africa)
2.
Indication: influenza
Phase: III
Summary: Randomised, double-blind, multi-centre, placebo- and active-controlled study to assess the efficacy and safety of a single oral dose of Xofluza in comparison with placebo or oseltamivir in adults and adolescents (aged ≥12) with influenza and who are at high risk of complications associated with influenza (e.g. asthma or chronic pulmonary disease, endocrine disorders, heart disease, aged ≥65, metabolic disorders, morbid obesity).
Sponsors: Shionogi & Co., Ltd (for Japan/Asia), Shionogi Inc. (USA), Shionogi Ltd. (Australia, New Zealand, South Africa)
3.
Indication: influenza
Phase: II
Summary: Study to assess the efficacy and safety of a single oral dose of Xofluza in comparison with placebo in otherwise healthy adults (aged ≥20 to ≤64) with influenza.
Sponsors: Shionogi & Co Ltd.
4.
Indication: Prophylaxis of Influenza
Phase: III
Summary: Study 1719T0834 was a phase 3, randomized, double-blind, multicenter, placebo-controlled study conducted in 749 subjects in Japan to evaluate the efficacy of a single oral dose of Xofluza compared with placebo in the prevention of influenza in subjects who are household members of influenza-infected patients.
Sponsors: Shionogi & Co., Ltd.
5.
Indication: pediatric patients (aged 1 to < 12 years)
Phase: III
Summary: Study CP40563 was a randomized, double-blind, multicenter, active-controlled study, designed to evaluate the safety, pharmacokinetics and efficacy of a single oral dose of Xofluza compared with oseltamivir in otherwise healthy pediatric patients (aged 1 to < 12 years) with influenza-like symptoms.
Sponsor: Hoffmann-La Roche
Publication of the results of clinical trials
The information given above and the links to the clinical data fulfil the requirements of Articles 71-73 of the Ordinance on Therapeutic Products (Therapeutic Products Ordinance, TPO) and amend the information published in association with the Swiss marketing authorisation for Xofluza. Articles 71-73 TPO apply to all medicinal products that were submitted as of January 2019 and were granted marketing authorisation by Swissmedic. The published data will help doctors and other healthcare service providers to take well-informed decisions on treatment and allow researchers to more easily build on the research carried out by Roche and its partners, as well as that carried out by other researchers, to ensure continued scientific progress.
This website contains information on products which is targeted to a wide range of audiences and could contain product details or information otherwise not accessible or valid in your country. Please be aware that we do not take any responsibility for accessing such information which may not comply with any legal process, regulation, registration or usage in the country of your origin.