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
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 | |||||
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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 |
Vaccination from 16 years | 16.10.2020 | 19.12.2020 Temporary authorisation |
Vaccination from 12 years | 10.05.2021 | 04.06.2021 Temporary authorisation |
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Booster dose for persons at especially high risk, 3rd dose for persons with impaired immunity | 15.09.2021 | 22.10.2021 Temporary authorisation |
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Booster: Extension of the booster dose to everyone aged 16 years and over |
15.09.2021 | 23.11.2021 Temporary authorisation |
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Vaccination 5-11 years | 19.11.2021 | 10.12.2021 Temporary authorisation |
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Spikevax | Moderna | Information for healthcare professionals (in German) Patient information (in German)
|
Vaccination from 18 years | 13.11.2020 | 12.01.2021 Temporary authorisation |
Vaccination from 12 years | 15.06.2021 | 09.08.2021 Temporary authorisation |
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Booster dose for persons at especially high risk, 3rd dose for persons with impaired immunity | 10.09.2021 | 26.10.2021 Temporary authorisation |
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Booster: Extension of the booster dose to everyone aged 18 years and over | 10.09.2021 | 26.10.2021 Temporary authorisation |
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Vaccination 6-11 years | 17.11.2021 | 13.05.2022 Temporary authorisation |
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Heterologous booster vaccination | 13.12.2021 | Under review2 | |||
Vaccination 6 months - 5 years | 16.05.2022 | 18.05.2022 Under review2 |
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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 |
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Vaxzevria | Astra Zeneca AG | Vaccinations for persons at esp. high risk and for the general population | 02.10.2020 | 02.11.2021 Withdrawn |
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CureVac | Curevac Swiss AG | Vaccination for general population | 16.04.2021 | 19.10.2021 Withdrawn |
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Nuvaxovid | Future Health Pharma GmbH | Information for healthcare professionals (in German) Patient information (in German) |
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 |
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Veklury (Active substance: Remdesivir) |
Gilead Sciences Switzerland Sàrl | 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 |
|
Ronapreve |
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 |