Current status of authorisations for combating COVID-19

This table (“dashboard”) shows the applications received by Swissmedic for the authorisation (or authorisation extension in the case of vaccines) for COVID-19 vaccines and therapeutic agents against COVID-19 and the current status of the authorisation procedures.

Authorisation procedures for vaccines against COVID-19
Vaccine Company Supplementary information Indication applied for Review commenced1

Status

Comirnaty Pfizer

Information for healthcare professionals (persons 12 years and older) in German

Patient information (persons 12 years and older) in German

Information for healthcare professionals (children 5 to <12 years) in German

Patient information (children 5 to <12 years) in German

SwissPAR (PDF, 1 MB, 30.04.2021)
Public Summary SwissPAR

Vaccination from 16 years 16.10.2020 19.12.2020
Temporary authorisation
Vaccination from 12 years 10.05.2021 04.06.2021
Temporary authorisation
Booster dose for persons at especially high risk, 3rd dose for persons with impaired immunity 15.09.2021 22.10.2021
Temporary authorisation
Booster:
Extension of the booster dose to everyone aged 16 years and over
15.09.2021 23.11.2021
Temporary authorisation
Vaccination 5-11 years 19.11.2021 10.12.2021
Temporary authorisation
Spikevax Moderna

Information for healthcare professionals (in German)

Patient information (in German)

 

SwissPAR (PDF, 883 kB, 03.12.2021)
Public Summary SwissPAR

Vaccination from 18 years 13.11.2020 12.01.2021
Temporary authorisation
Vaccination from 12 years 15.06.2021 09.08.2021
Temporary authorisation
Booster dose for persons at especially high risk, 3rd dose for persons with impaired immunity 10.09.2021 26.10.2021
Temporary authorisation
Booster: Extension of the booster dose to everyone aged 18 years and over 10.09.2021 26.10.2021
Temporary authorisation
Vaccination 6-11 years 17.11.2021 13.05.2022
Temporary authorisation
Heterologous booster vaccination 13.12.2021 Under review2
Vaccination 6 months - 5 years 16.05.2022 18.05.2022
Under review2
Covid-19 Vaccine Janssen

Janssen Cilag AG

Information for healthcare professionals (in German)

Patient information (in German)

Vaccination from 18 years 03.12.2020 22.03.2021
Temporary authorisation
Booster dose 22.12.2021 27.12.2021
Temporary authorisation
Vaxzevria Astra Zeneca AG   Vaccinations for persons at esp. high risk and for the general population 02.10.2020 02.11.2021
Withdrawn
CureVac Curevac Swiss AG   Vaccination for general population 16.04.2021 19.10.2021
Withdrawn

Nuvaxovid Future Health Pharma GmbH

Information for healthcare professionals (in German)

Patient information (in German)

SwissPAR (PDF, 402 kB, 24.05.2022)

Vaccination from 18 years 14.02.2022 12.04.2022
Temporary authorisation

Authorisation procedures for therapeutic agents against COVID-19

Therapeutic agent3 Company Supplementary information Indication Review commenced1 Status
Veklury
(Active substance: Remdesivir)
Gilead Sciences Switzerland Sàrl

SwissPAR (PDF, 522 kB, 22.01.2021)
Public Summary SwissPAR

Treatment of adult COVID-19 patients 01.07.2020 25.11.2020
Temporary authorisation
Olumiant
(Active substance: Baricitinib)
Eli Lilly (Suisse) SA

Information for healthcare professionals (in German)

Patient information (in German)

COVID-19 disease 29.01.2021 10.08.2021
Authorisation
Avigan
(Active substance: Favipiravir)
Dr. Reddy`s Laboratories Ltd.   Mild to moderately severe COVID-19 23.11.2020

18.08.2021
Withdrawn

Ronapreve
(Active substances: Casirivimab/Imdevimab)

Roche Information for healthcare professionals (in German) Covid-19 10.03.2021 23.12.2021
Authorisation
Bamlanivimab & Etesevimab Eli Lilly (Suisse) SA   Covid-19 26.04.2021 09.11.2021
Withdrawn
Xevudy
(Active substance: Sotrovimab)
Glaxo SmithKline AG
Information for healthcare professionals (in German) Covid-19 11.05.2021 14.01.2022
Temporary authorisation
Lagevrio
(Active substance: Molnupiravir)
MSD Merck Sharp & Dohme AG   Covid-19 16.08.2021 In rolling review2
Actemra
(Active substance: Tocilizumab)
Roche   Covid-19 20.08.2021 In rolling review2
Regkirona
(Active substance: Regdanvimab)
iQone Healthcare Switzerland Information for healthcare professionals (in German) Treatment of adult COVID-19 patients 28.07.2021 12.01.2022
Temporary authorisation
Favipiravir Ideogen
(Active substance: Favipiravir)
Ideogen AG   Treatment of adult COVID-19 patients 12.01.2022 Under review
Paxlovid
(Active substances: Nirmatrelvir [PF-07321332]/Ritonavir)
Pfizer AG   Treatment of adult COVID-19 patients 18.01.2022 In rolling review2
Evusheld
(Active substances: Tixagevimab/Cilgavimab)
AstraZeneca AG   Prophylaxis of COVID-19 10.02.2022 Under review
1 Review begins as soon as the formal check on the documents submitted is complete. The check lasts from a few hours up to a few days.
2
“Under (rolling) review” denotes that Swissmedic is examining the data submitted with regard to safety, efficacy and quality, is clarifying open issues with the companies and/or is demanding additional results
3
Only the first authorisation in the context of COVID-19 is listed; for the sake of clarity, no indication extensions are shown