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
3Only the first authorisation in the context of COVID-19 is listed; for the sake of clarity, no indication extensions are shown
4 Conversion to ordinary authorisation applied for, in respect of vaccine for which temporary authorisation had been issued.
5 Temporary authorisation extended by Swissmedic (until official decision published, but not beyond 13.09.2023).
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
Indication | Review commenced1 | Status |
Supplementary information |
---|---|---|---|
Vaccination from 16 years | 16.10.2020 | 19.12.2020 Temporary authorisation4 5 |
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 Information for healthcare Original/Omicron BA.1 in German |
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 |
|
Booster: 5-11 years | 31.05.2022 | Under review2 | |
Comirnaty bivalent Original/Omicron BA.1 Authorisation of an Omicron-adapted vaccine from 18 years |
02.08.2022 | 10.10.2022 Temporary authorisation |
|
Vaccination for children aged from 6 months up to 5 years | 02.09.2022 | Under review2 |
|
Comirnaty bivalent Original/Omicron BA.4-5 Application for authorisation of a second bivalent COVID-19 vaccine |
22.09.2022 | Under review2 |
Indication | Review commenced1 | Status |
Supplementary information |
---|---|---|---|
Vaccination from 18 years | 13.11.2020 | 12.01.2021 Temporary authorisation4 |
Information for healthcare professionals (in German) Patient information (in German) Information for healthcare professionals Bivalent Original / Omicron (in German) Patient information Bivalent Original / Omicron (in German) |
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 |
|
Vaccination for children aged from 6 months up to 5 years | 18.05.2022 | Under review2 | |
Spikevax bivalent Original/Omicron BA.1 Authorisation for an Omicron-adapted vaccine from 18 years | 24.06.2022 | 29.08.2022 Temporary authorisation |
|
Spikevax bivalent Original / Omicron BA.4-5 Application for authorisation of a second bivalent COVID-19 vaccine |
18.11.2022 | Under review2 |
Indication | Review commenced1 | Status |
Supplementary information |
---|---|---|---|
Vaccination from 18 years | 03.12.2020 | 22.03.2021 Temporary authorisation |
Information for healthcare professionals (in German) Patient information (in German) |
Booster dose | 22.12.2021 | 27.12.2021 Temporary authorisation |
Indication | Review commenced1 | Status |
Supplementary information |
---|---|---|---|
Vaccination from 18 years | 14.02.2022 | 12.04.2022 Temporary authorisation |
Information for healthcare professionals (in German) Patient information (in German) |
Application for indication extension to 12 to 18-year-olds and booster dose | 06.07.2022 | 02.09.2022 Temporary authorisation |
Authorisation procedures for therapeutic agents against COVID-19
Therapeutic agent3 | Company | Indication | Review commenced1 | Status | Supplementary information |
---|---|---|---|---|---|
Evusheld (Active substances: Tixagevimab/Cilgavimab) |
AstraZeneca AG | Prophylaxis of COVID-19 | 10.02.2022 | 15.09.2022 Temporary authorisation |
|
Treatment of Covid-19 | 02.08.2022 | Under review | |||
Lagevrio (Active substance: Molnupiravir) |
MSD Merck Sharp & Dohme AG | Covid-19 | 16.08.2021 | In rolling review2 | |
Olumiant (Active substance: Baricitinib) |
Eli Lilly (Suisse) SA | COVID-19 disease | 29.01.2021 | 10.08.2021 Authorisation |
Information for healthcare professionals (in German) Patient information (in German) |
Paxlovid (Active substances: Nirmatrelvir [PF-07321332]/Ritonavir) |
Pfizer AG | Treatment of adult COVID-19 patients | 18.01.2022 | 15.06.2022 Temporary authorisation |
Information for healtcare professionals (in German) |
Regkirona (Active substance: Regdanvimab) |
iQone Healthcare Switzerland | Treatment of adult COVID-19 patients | 28.07.2021 | 12.01.2022 Temporary authorisation |
Information for healthcare professionals (in German) |
Ronapreve (Active substances: Casirivimab/Imdevimab) |
Roche | Covid-19 | 10.03.2021 | 23.12.2021 Authorisation |
Information for healthcare professionals (in German) |
Sabizabulin | R.D. Pharma Sàrl | Treatment of Covid-19 | 14.12.2022 | In rolling review2 | |
Veklury (Active substance: Remdesivir) |
Gilead Sciences Switzerland Sàrl | Treatment of adult COVID-19 patients | 01.07.2020 | 25.11.2020 Temporary authorisation |
|
Treatment of pediatric COVID-19 patients | 09.08.2022 | Under review | |||
Xevudy (Active substance: Sotrovimab) |
Glaxo SmithKline AG |
Covid-19 | 11.05.2021 | 14.01.2022 Temporary authorisation |
Information for healthcare professionals (in German) SwissPAR (PDF, 507 kB, 03.11.2022) Public Summary SwissPAR |
Therapeutic agent3 | Company | Indication | Review commenced1 | Status |
---|---|---|---|---|
Actemra (Active substance: Tocilizumab) |
Roche | Covid-19 | 20.08.2021 | 11.08.2022 Withdrawn |
Avigan (Active substance: Favipiravir) |
Dr. Reddy`s Laboratories Ltd. | Mild to moderately severe COVID-19 | 23.11.2020 | 18.08.2021 |
Bamlanivimab & Etesevimab | Eli Lilly (Suisse) SA | Covid-19 | 26.04.2021 | 09.11.2021 Withdrawn |
Favipiravir Ideogen (Active substance: Favipiravir) |
Ideogen AG | Treatment of adult COVID-19 patients | 12.01.2022 | 04.10.2022 Withdrawn |