Status as at 30 April 2024 – This page is no longer being updated. You can find the Information for healthcare professionals and Patient information for authorised medicinal products here.
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
Comirnaty (Pfizer)
Spikevax (Moderna)
Nuvaxovid (Future Health Pharma GmbH)
Revocations
Withdrawn
| Indication | Review commenced1 | Status |
Supplementary information |
|---|---|---|---|
| Vaccination from 12 years | 16.10.2020 | 27.03.2023 Authorisation |
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 5-11 years | 19.11.2021 | 27.03.2023 Authorisation |
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| Booster: 5-11 years | 31.05.2022 | 14.10.2022 Authorisation |
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| Vaccination for children aged from 6 months up to 5 years | 02.09.2022 | 04.09.2023 6 months up to < 2 years: Temporary authorisation |
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| 04.09.2023 2-5 years: Authorisation |
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| Comirnaty bivalent Original/Omicron BA.1 Authorisation of an Omicron-adapted vaccine from 18 years |
02.08.2022 | 10.10.2022 Temporary authorisation |
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| Comirnaty bivalent Original/Omicron BA.4-5 Application for authorisation of a second bivalent COVID-19 vaccine |
22.09.2022 | 11.04.2023 Authorisaton |
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| Comirnaty monovalent XBB.1.5 Examining application for vaccine against Omicron subvariant XBB.1.5 |
19.07.2023 | 22.09.2023 Authorisation |
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| Comirnaty monovalent XBB.1.5 Application for indication extension to children aged 5 to < 12 |
04.01.2024 | in assessment |
| Indication | Review commenced1 | Status |
Supplementary information |
|---|---|---|---|
| Vaccination from 18 years | 13.11.2020 | 18.09.2023 Authorisation |
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 | 18.09.2023 Authorisation |
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| Booster dose for persons at especially high risk, 3rd dose for persons with impaired immunity | 10.09.2021 | 18.09.2023 Authorisation |
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| Booster: Extension of the booster dose to everyone aged 18 years and over | 10.09.2021 | 18.09.2023 Authorisation |
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| Vaccination 6-11 years | 17.11.2021 | 18.09.2023 Authorisation |
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| Vaccination for children aged from 6 months up to 5 years | 18.05.2022 | 18.09.2023 6 months up to < 2 years: Temporary authorisation |
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| 18.09.2023 2-5 years: Authorisation |
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| Spikevax bivalent Original/Omicron BA.1 Authorisation for an Omicron-adapted vaccine from 18 years | 24.06.2022 | 29.08.2022 Temporary authorisation |
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| Spikevax bivalent Original / Omicron BA.4-5 Application for authorisation of a second bivalent COVID-19 vaccine |
18.11.2022 | 08.03.2023 Authorisation |
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| Spikevax monovalent Omicron XBB.1.5 Examining application for vaccine against Omicron subvariant XBB.1.5 |
13.07.2023 | 28.09.2023 Authorisation |
| Indication | Review commenced1 | Status |
Supplementary information |
|---|---|---|---|
| Vaccination from 12 years | 14.02.2022 | 21.09.2023 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 | 21.09.2023 Authorisation |
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| Nuvaxovid monovalent XBB.1.5 Examining application for vaccine against Omicron subvariant |
30.08.2023 | 18.12.2023 Withdrawn |
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| Nuvaxovid, dispersion for injection (68473) | 21.03.2024 Discontinuation of authorisation |
| Vaccine | Company | Indication | Review commenced1 | Status |
Supplementary information | Revocations |
|---|---|---|---|---|---|---|
| Covid-19 Vaccine Janssen | Janssen Cilag AG | Vaccination from 18 years | 03.12.2020 | 22.03.2021 Temporary authorisation6 |
Information for healthcare professionals (in German) Patient information (in German) |
01.06.2023 Revocation of authorisation due to renunciation of distribution |
| Booster dose | 22.12.2021 | 27.12.2021 Temporary authorisation |
01.06.2023 Revocation of authorisation due to renunciation of distribution |
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| Nuvaxovid | Future Health Pharma GmbH | 21.03.2024 Discontinuation of authorisation |
| Vaccine | Company | Indication | Review commenced1 | Status |
|---|---|---|---|---|
| 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 monovalent XBB.1.5 | Future Health GmbH | Vaccination for the Omicron sub-variant XBB.1.5 | 30.08.2023 | 18.12.2023 Withdrawn |
Authorisation procedures for therapeutic agents against COVID-19
Therapeutic agents
Withdrawn
| Therapeutic agent3 | Company | Indication | Review commenced1 | Status | Supplementary information |
|---|---|---|---|---|---|
| Evusheld (Active substances: Tixagevimab/Cilgavimab) |
AstraZeneca AG | Prophylaxis of COVID-19 | 10.02.2022 | 10.01.2024 Conversion from a temporary authorisation to an authorisation with completed documentation |
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| Treatment of Covid-19 | 02.08.2022 | 10.01.2024 Conversion from a temporary authorisation to an authorisation with completed documentation |
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| 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 | 05.04.2024 Conversion from a temporary authorisation to an authorisation with completed documentation |
Information for healtcare professionals (in German) |
| Ronapreve (Active substances: Casirivimab/Imdevimab) |
Roche | Covid-19 | 10.03.2021 | 23.12.2021 Authorisation |
Information for healthcare professionals (in German) |
| Veklury (Active substance: Remdesivir) |
Gilead Sciences Switzerland Sàrl | Treatment of adult COVID-19 patients | 01.07.2020 | 25.11.2020 02.02.2023 |
|
| Treatment of pediatric COVID-19 patients | 09.08.2022 | 05.04.2023 Indication extension |
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| Xevudy (Active substance: Sotrovimab) |
Glaxo SmithKline AG |
Covid-19 | 11.05.2021 | 19.03.2024 Conversion from a temporary authorisation to an authorisation with completed documentation |
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 |
| Lagevrio (Active substance: Molnupiravir) |
MSD Merck Sharp & Dohme AG | Covid-19 | 16.08.2021 | 24.02.2023 Withdrawn |
| Regkirona (Active substance: Regdanvimab) |
iQone Healthcare Switzerland | Treatment of adult COVID-19 patients | 28.07.2021 | 12.01.2022 18.01.2023
|
| Sabizabulin | R.D. Pharma Sàrl | Treatment of Covid-19 | 14.12.2022 | 14.06.2023 Withdrawn |
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
4Conversion to ordinary authorisation applied for, in respect of vaccine for which temporary authorisation had been issued.
5Temporary authorisation extended by Swissmedic (until official decision published, but not beyond 13.09.2023).
6Temporary authorisation extended by Swissmedic (until official decision published, but not beyond 15.01.2024).
7 Assessment as part of a simple update procedure