The table below shows the COVID-19 vaccines and treatments regulatory status at a glance. It is updated on an ad hoc basis. Regulatory status from 8 May 2020 – 23 September 2021 is covered.
On mobile, the table is best viewed by scrolling sideways.
For regulatory status prior after 23 September 2021, please visit:
- post 2 of 3 for regulatory status between 24 September 2021 – 13 April 2022
- post 3 of 3 for regulatory status from 14 April 2022
Other news including on vaccines, treatments, trials and side effects, here.
Company(ies)/ Others | Product | Issuing regulatory agency or organisation | Regulatory status | Further information | Date |
---|---|---|---|---|---|
Janssen Cilag Ltd. UK | COVID-19 Vaccine Janssen suspension for injection COVID-19 vaccine (Ad26.COV2-S [recombinant]) | MHRA/UK | 28 May 2021 Conditional marketing authorisation granted. Information for healthcare professionals and the public. | On 23 September 2021, the shelf life of the drug product was updated in accordance with the approved stability protocol from the current shelf-life of 3 months to 4.5 months when stored at 2 to 8°C. SmPC sections 6.3 Shelf life and 6.4 Special precautions for storage and the corresponding section in the Package leaflet also updated to reflect that that transportation is also part of the chemical and physical inuse stability of the opened vial (after first puncture). | 23 Sept 2021 |
Pfizer/BioNTech | mRNA Pfizer-BioNTech COVID-19 Vaccine (Comirnaty) | FDA/US | Emergency Use Authorisation granted on 11 Dec 2020 FDA Allows More Flexible Storage, Transportation Conditions on 25 Feb 2021 On 7 May 2021, Initiation of a Biologics License Application (BLA) with the (FDA) for approval of the vaccine to prevent COVID-19 in individuals 16 years of age and older. 10 May 2021 Emergency use authorisation (EUA) for the prevention of COVID-19 expanded to include adolescents 12 through 15 years of age. On 12 August 2021, the FDA amended the EUA to allow for the use of an additional dose in certain immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise. | On 22 September 2021, EUA amended to allow for use of a single booster dose, to be administered at least six months after completion of the primary series in people 65 years of age and older, those who are at high risk of severe COVID-19, health care workers, and other people at high risk of serious complications due to institutional or occupational exposure to SARS-CoV-2. On 23 August 2021, approval granted for the prevention of COVID-19 disease in individuals 16 years of age and older. Prescribing information and other information | 22 Sep 2021 |
Roche-Regenron | casirivimab and imdevimab | HSA/Singapore | Interim authorisation granted, | 21 Sep 2021 | |
Janssen-Cilag International N.V. | COVID-19 Vaccine Janssen Ad26.COV2.S viral vector vaccine | EMA/EU | Conditional marketing authorisation granted on 11 Mar 2021. Overview, authorisation details, Product information and Assessment history. 14 April 2021 Janssen has announced their decision to proactively delay the rollout of the vaccine in the EU while investigations continue. 20 April 2021 EMA finds possible link to very rare cases of unusual blood clots with low blood platelets. Its safety committee, (PRAC) concluded that a warning about unusual blood clots with low blood platelets should be added to the product information for COVID-19 Vaccine Janssen. PRAC also concluded that these events should be listed as very rare side effects of the vaccine. On 25 June 2021, Approval of additional manufacturing site located in Anagni, Italy, operated by Catalent Anagni SRL. The site will perform finished product manufacturing. On 2 July 2021 EMA has approved a scale-up of the active substance manufacturing process at Janssen Biologics B.V. The plant, which is located in Leiden, the Netherlands, produces all active substance for the manufacture of the EU supply of COVID-19 Vaccine Janssen, the COVID-19 vaccine developed by Janssen-Cilag International NV. | On 21 September 2021, the shelf life of the drug product was updated in accordance with the approved stability protocol from the current shelf-life of 3 months to 4.5 months when stored at 2 to 8°C. SmPC sections 6.3 Shelf life and 6.4 Special precautions for storage and the corresponding section in the Package leaflet also updated to reflect that that transportation is also part of the chemical and physical inuse stability of the opened vial (after first puncture). On 6 August 2021 PRAC recommended updating the product information to include immune thrombocytopenia as an ADR, as well as a warning to alert HCPs and people taking the vaccine of this possible side effect. PRAC has also recommended amending the product information to add dizziness and tinnitus as adverse reactions to alert HCPs and people taking the vaccine of these potential side effects. On 22 July PRAC has confirmed that Guillain-Barré syndrome (GBS) will be listed as a very rare side effect of COVID-19 Vaccine Janssen and a warning will be included in the product information to raise awareness among healthcare professionals and people taking the vaccine. On 9 July 2021, The PRAC has recommended that people who have previously had capillary leak syndrome must not be vaccinated with COVID-19 Vaccine Janssen. The Committee also recommended that capillary leak syndrome should be added to the product information as a new side effect of the vaccine, together with a warning to raise awareness among healthcare professionals and patients of this risk. | 21 Sep 2021 |
Pfizer-BioNTech | Coronavirus mRNA vaccine Comirnaty® (BNT162b2) | Swissmedic | Approved via normal approval procedure on 19 Dec 2020. On 30 March 2021, New storage conditions approved This means that The vials can now be transported and stored for up to two weeks at – 25 to -15 degrees Celsius instead of between -90 and -60 degrees Celsius. On 2 Jun 2021 Swissmedic approved an application for a quality amendment. Thus from now on, the unopened, thawed vials of the COVID-19 vaccine Comirnaty® can be stored at 2–8 °C in a temperature-controlled refrigerator for up to a month. | On 21 September 2021, shelf-life extended from 6 to 9 months at ultralow temperature (<-60°C) for Comirnaty, concentrate for the manufacture of a dispersion for injection On 16 September 2021, Swissmedic confirmed that Pfizer has already submitted an applicaton seeking modification of the current dosage regime, to add a third booster dose and the application is under review. On 4 Jun 2021, Swissmedic extended the temporary ordinary authorisation of the Pfizer/BioNTech coronavirus vaccine to include young people aged between 12 and 15. | 21 Sep 2021 |
AstraZeneca AB | Vaxzevria – COVID-19 Vaccine (ChAdOx1-S [recombinant]) (formerly COVID-19 Vaccine AstraZeneca) | EMA/EU | Conditional marketing authorisation granted on 29 Jan 2021. Overview, authorisation details, Product information and assessment history. The updated EMA recommendations for healthcare professionals are available in the vaccine’s product information updated on 20 May 2021. On 21 May 2021 EMA provided additional advice on blood clots or low blood platelets occurring after vaccination with Vaxzevria. On 11 Jun 2021 PRAC has concluded that people who have previously had capillary leak syndrome (CLS) must NOT be vaccinated with Vaxzevria (i.e. a contraindication). It has also also concluded that capillary leak syndrome should be added to the product information as a new side effect of the vaccine, together with a warning to raise awareness among healthcare professionals and patients of this risk. On 9 July 2021, The PRAC has recommended a change to the product information for Vaxzevria (formerly COVID-19 Vaccine Astrazeneca) to include a warning to raise awareness among HCPs and people taking the vaccine of cases of Guillain-Barre syndrome (GBS) reported following vaccination. | On 17 September 2021, CHMP has concluded its further analysis of data on the risk of unusual blood clots linked to low levels of blood platelets (Article 5(3) review). EMA’s recommendation remains to continue giving a second dose of Vaxzevria between 4 and 12 weeks after the first, in line with the product information On 6 August 2021, as part of the review of monthly summary safety reports for Vaxzevria, the PRAC continues to analyse data provided by the marketing authorisation holder on cases of Guillain-Barré syndrome (GBS) reported following vaccination. In the context of the next monthly summary safety report, the PRAC has requested the marketing authorisation holder to provide additional data, to clarify whether further updates to the product information and the RMP are necessary. | 17 Sep 2021 |
Moderna Switzerland GmbH | COVID-19 mRNA Vaccine Moderna (Spikevax) | Swissmedic | Temporary Authorisation granted on 12 Jan 2021 | On 16 September 2021, Swissmedic confirmed that Moderna has already submitted an applicaton seeking modification of the current dosage regime, to add a third booster dose and the application is under review. On 9 August 2021, approval of Indication extension for Spikevax vaccine for 12- to 17-year-olds | 16 Sep 2021 |
Eli Lilly and Co. | Monoclonal antibodies bamlanivimab and etesevimab administered together | FDA/US | On 9 February 2021, Emergency Use Authorisation Issued. On 18 March 2021, revised Fact sheet for healthcare providers to address SARS-COV-2 variants Fact sheet for healthcare providers | On 16 September 2021 EUA revised, to include emergency use as post-exposure prophylaxis (prevention) for COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death. | 16 Sep 2021 |
BioNTech Manufacturing GmbH | Pfizer-BioNTech Comirnaty® COVID-19 vaccine | Health Canada | Authorised in accordance with section 5 of the Interim Order re COVID-19 on 9 Dec 2020. Pediatric indication (ages 12-15) – Authorised (with terms and conditions) on 5 May 2021 Information for healthcare professionals | The vaccine was authorised under the Interim Order for use in relation to COVID-19. The interim order expired on September 16, 2021. On this date, the vaccine transitioned to an authorisation under the Food and Drug Regulations. | 16 Sep 2021 |
Pfizer/Biontech | Comirnaty Vaccine | SAHPRA/South Africa | On 16 March 2021, emergency use authorisation granted under Section 21 of the Medicines and Related Substance Act 101 of 1965 | On 10 September 2021, SAHPRA has granted emergency use authorisation for the use of the vaccine under Section 21 of the Medicines and Related Substance Act 101 of 1965 to include individuals twelve years (12) years and older. | 10 Sep 2021 |
Pfizer/BioNTech | Coronavirus mRNA vaccine Comirnaty® (BNT162b2) | EMA/EU | Conditional Marketing Authorisation granted on 21 Dec 2020. Overview, Authorisation details, Product Information and assessment history On 26 March 2021, CHMP gave a positive opinion to allow transportation and storage of vials of this vaccine at temperatures between -25 to -15˚C (i.e. the temperature of standard pharmaceutical freezers) for a one-off period of two weeks. On 3 May 2021 EMA has started evaluating an application to extend the use of the COVID-19 vaccine Comirnaty to include young people aged 12 to 15. EMA will communicate the outcome of its evaluation, which is expected in June 2021 unless supplementary information is needed. On 1 June 2021 EMA has recommended the approval of additional manufacturing and filling lines at Pfizer’s vaccine manufacturing site in Puurs, Belgium On 22 June 2021, EMA has approved two additional manufacturing sites for the production of the vaccine.One site, located in Reinbek, Germany, is operated by Allergopharma GmbH & Co. KG. The other in Stein, Switzerland, is operated by Novartis Pharma. The sites will perform finished product manufacturing steps at different stages of the process. | On 9 September 2021, the CHMP has approved additional manufacturing sites for the production of Comirnaty. One site, located in Frankfurt am Main, Germany, is operated by Sanofi-Aventis Deutschland GmbH. The other in Hameln, also in Germany, is operated by Siegfried Hameln GmbH. Both sites will manufacture finished product. On 6 September 2021, EMA has started evaluating an application (via accelerated assessment) for the use of a booster dose of Comirnaty to be given 6 months after the second dose in people aged 16 years and older. Separately, EMA is also assessing data from the literature on the use of an additional, third dose of an mRNA vaccine (Comirnaty) in severely immunocompromised people. On 24 August 2021, CHMP has approved an additional manufacturing site for the production of Comirnaty, The site, located in Saint Rémy sur Avre, France, is operated by Delpharm and will manufacture finished product. On 9 July 2021, The PRAC has concluded that myocarditis and pericarditis can occur in very rare cases following vaccination with Comirnaty. The Committee is therefore recommending listing myocarditis and pericarditis as new side effects in the product information together with a warning to raise awareness among healthcare professionals and people taking these vaccines. | 9 Sep 2021 |
Oxford University/ AstraZeneca | Vaxzevria -COVID-19 Vaccine AstraZeneca (ChAdOx1 S [recombinant] | MHRA/UK | 15 Apr 2021 Information for Healthcare Professionals and for UK Recipients on COVID-19 Vaccine AstraZeneca updated with new information about extremely rare, unlikely to occur blood clots. On 24 June 2021 Conditional Marketing Authorisation granted. This replaces the temporary approval granted on 30 Dec 2020. SmPC, Information for Healthcare Professionals and Patient Information Leaflet. | On 9 September 2021, the information for Healthcare professionals and UK recipients updated to include information on a third dose at least 8 weeks after the second dose when the potential benefits outweigh any potential risks.The information has not been added to the SmPC and PIL. Also the Regulation 174 Conditions document updated with additional pharmacovigilance conditions. On 20 August 2021, Updated the PIL and SmPC updated to include new warning on Guillaine-Barre Syndrome. On 16 July 2021, updated to reflect the addition of capillary leak syndrome as a contraindication. Also the name of the COVID-19 Vaccine AstraZeneca in the Conditional Marketing Authorisation product information changed to the brand name – Vaxzevria. | 9 Sep 2021 |
Pfizer/BioNTech | COVID-19 mRNA Vaccine BNT162b2 | MHRA/UK | On 21 December 2020, the Conditional Marketing Authorisation was issued by the European Medicines Agency (EMA) and was automatically converted to a GB CMA on 1 January 2021. Information for healthcare professionals and the public On 20 May 2021 the Information for Healthcare Professionals, Information for UK recipients and Conditions of Authorisation documents was updated to reflect a change that once removed from the freezer, the undiluted vaccine has a maximum shelf life of up to 1 month (31 days). This was previously 5 days. 4 June 2021 MHRA Updated Conditions of Authorisation, Information for Healthcare Professionals and Information for UK Recipients documents in line with an extension to the current UK approval of the Pfizer/BioNTech COVID-19 vaccine that allows its use in 12- to 15-year-olds. | On 9 September 2021, the information for Healthcare professionals and UK recipients updated to include information on a third dose at least 8 weeks after the second dose when the potential benefits outweigh any potential risks.The information has not been added to the SmPC and PIL. Also the Regulation 174 Conditions document updated with additional pharmacovigilance conditions. On 2 August 2021 , the conditions of authorisation of the vaccine were updated. In Section 4.4 of the SmPC (Special warnings and precautions for use), the following vaccine stress-related responses “tachycardia, paraesthesia and dizziness” have been listed. In Section 4.8 (Undesirable effects), The following ADR “Extensive swelling of the vaccinated limb” has been listed with frequencies and a related footnote has been added. Name of product updated to Comirnaty. On 25 June, a warning on myocarditis added to the Information for UK recipients and the Information for Healthcare Professionals. | 9 Sep 2021 |
MODERNA BIOTECH SPAIN, S.L. | COVID-19 Vaccine Moderna (now known as Spikevax) mRNA-1273 vaccine | EMA/EU | Conditional marketing authorisation granted on 6 Jan 2021 Overview, Authorisation details, Product Information and assessment history Clinical data to support the authorisation, published 2 March 2021 On 4 June 2021 two new sites for the manufacturing of active substance and finished product intermediates, located in the US (ModernaTX, Inc., Norwood, Massachusetts and Lonza Biologics, Inc., Portsmouth, New Hampshire), were approved by CHMP. On 11 June 2021, the CHMP has approved a new manufacturing site for the production of Moderna COVID-19 vaccine finished product. The site, operated by Recipharm, is located in Monts, France. Additionally, the CHMP has also given a positive opinion for the addition of several alternative sites responsible for batch control/testing. On 9 July 2021, The PRAC has concluded that myocarditis and pericarditis can occur in very rare cases following vaccination with Spikevax (previously COVID-19 Vaccine Moderna) . The Committee is therefore recommending listing myocarditis and pericarditis as new side effects in the product information, together with a warning to raise awareness among healthcare professionals and people taking these vaccines. | On 6 September 2021 , EMA is assessing data from the literature on the use of an additional, third dose of an mRNA vaccine (SpikeVax) in severely immunocompromised people (i.e., with weakened immune systems) On 24 August 2021, CHMP has approved an additional manufacturing site for the production of Spikevax, The site, located in Bloomington, Indiana, United States (US), is operated by Catalent. The site will perform finished product manufacturing. On 30 July 2021 the CHMP has approved a scale-up of the active substance production process at Moderna’s COVID-19 vaccine manufacturing sites in the United States (US). recommendation is expected to have significant impact on the supply of Spikevax. On 23 July 2021 the CHMP has recommended granting an extension of indication for the COVID-19 vaccine Spikevax to include use in children aged 12 to 17 years. The vaccine is already authorised for use in people aged 18 and above. 24 August 2021, CHMP has approved an additional manufacturing site for the production of Spikevax, The site, located in Bloomington, Indiana, United States (US), is operated by Catalent. The site will perform finished product manufacturing. On 30 July 2021 the CHMP has approved a scale-up of the active substance production process at Moderna’s COVID-19 vaccine manufacturing sites in the United States (US). recommendation is expected to have significant impact on the supply of Spikevax. On 23 July 2021 the CHMP has recommended granting an extension of indication for the COVID-19 vaccine Spikevax to include use in children aged 12 to 17 years. The vaccine is already authorised for use in people aged 18 and above. | 6 Sep 2021 |
Moderna Australia Pty Ltd | mRNA COVID-19 Vaccine, Spikevax (elasomeran) | TGA/Australia | On 9 August 2021 Provisional approval granted for use in individuals aged 18 years and older. Provisional determination granted on 24 June 2021. Product information available here. | On 3 September 2021 provisional approval granted for use in individuals 12 years and older. | 3 Sep 2021 |
Pfizer Inc and BioNTech | Comirnaty COVID-19 vaccine | Anvisa/Brazil | On 28 May, new conditions of storage authorised allowing the vaccine to be kept at a controlled temperature between 2 and 8 degrees Celsius for up to 31 days. Full approval granted on 23 February 2021. Prescribing information and package leaflet in Portuguese. | On 1 September 2021, inclusion of the company Exelead , located in Indianapolis, Indiana, in the US approved as an alternative manufacturer of Pfizer’s vaccine, Comirnaty. On 11 June 2021, Anvisa authorised the vaccine in children 12 years of age or older. | 1 Sep 2021 |
To be confirmed | Abdala vaccine | Cofepris/ Mexico | Committee on New Molecules (CMN), experts gave a favorable opinion on the authorization for emergency use of the Abdala vaccine. This represents a step prior to authorisation for emergency use | 30 Aug 2021 | |
Laboratorios de Biológicos y Reactivos de México SA de CV (Birmex ) | Sinopharm vaccine COVID-19 Vaccine (Vero-Cell) | Cofepris/Mexico | Authorised for emergency use | 26 Aug 2021 | |
BioNTech Manufacturing GmbH | Comirnaty (Pfizer-BioNTech COVID-19 Vaccine) | FDA/US | Approved for use for the prevention of COVID-19 disease in individuals 16 years of age and older The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals. | 23 Aug 2021 | |
Gilead Sciences México SRL de CV | Remdesivir | Cofepris/Mexico | CMN granted a favourable opinion. This is a step prior to authorisation for emergency use. | 23 Aug 2021 | |
MODERNA BIOTECH SPAIN, S.L. | COVID-19 vaccine Moderna (Spikevax) | MHRA/UK | Temporary approval was granted on 8 Jan 2021. This was replaced with a conditional marketing authorisation granted on 1 Apr 2021. An SmPC, a Patient Information Leaflet and a Public Assessment Report are available here. On 25 June 2021, the Summary of Product Characteristics and the Patient Information Leaflet were updated to include a warning about myocarditis and pericarditis | On 20 August 2021, sections 6.3, 6.4 and 6.6 of the SmPC were updated. Further information on all updates is available on the MHRA website here by clicking on ‘See all updates’. On 17 August 2021, Conditional Marketing Authorisation (CMA) extension granted that allows its use in 12- to 17-year-olds. | 20 Aug 2021 |
M/s Cadila Healthcare Limited | Novel Corona Virus-2019-nCov vaccine (recombinant DNA) (ZyCoV-D) | CDSCO/ India | Emergency use authorisation granted for restricted use for the prevention of COVID-19 | 20 Aug 2021 | |
GlaxoSmithKline Australia Pty Ltd (GSK) | Monoclonal antibody treatment, Sotrovimab (Xevudy) | TGA/Australia | Provisional determination granted on 14 April 2021 | On 20 August 2021, provisional approval granted for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with COVID-19 who do not require initiation of oxygen due to COVID-19 and who are at increased risk of progression to hospitalisation or death. | 20 Aug 2021 |
AstraZeneca Pty Limited | Vaxzevria | TGA/Australia | On 19 August 2021, approval granted for name change of its COVID-19 Vaccine AstraZeneca to VAXZEVRIA. | On 16 Feb 2021, provisional registration granted for Active immunisation of individuals ≥ 18 years old for the prevention of coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2. | 19 Aug 2021 |
Roche Products Ltd. UK Developed by Regeneron/Roche. | Ronapreve monoclonal antibody combination product (consisting of casirivimab and imdevimab) | MHRA/UK | On 19 August 2021 Conditional Marketing Authorisation granted with an indication for use in the prevention and treatment of acute COVID-19 infection for the UK. | Information for healthcare professionals | 19 Aug 2021 |
M/S Cadial Healthcare Limited. | Novel Corona Virus-2019-nCov vaccine (recombinant DNA) (ZyCoV-D) | CDSCO/india | Emergency use authorisation granted for restricted use for the prevention of COVID-19 | 18 Aug 2021 | |
Moderna Inc. | Moderna Covid-19 (mRNA-1273) vaccine (Spikevax) | Cofepris/Mexico | Authorisation for emergency use granted. | 18 Aug 2021 | |
Moderna TX Inc. | Moderna COVID-19 Vaccine | FDA/US | Emergency Use Authorisation on 18 Dec 2020 On June 25, 2021, the FDA revised the patient and provider fact sheets regarding the suggested increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart) following vaccination | On 12 August 2021, the FDA amended the EUA to allow for the use of an additional dose in certain immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise. Updated Fact sheet for healthcare providers on 12 August 2021 | 12 Aug 2021 |
Merck Sharp & Dohme (Australia) Pty Ltd (MSD) | oral antiviral monotherapy, Molnupiravir | TGA/Australia | Provisional determination granted. | 10 Aug 2021 | |
M/s Johnson & Johnson Pvt. Ltd. (Importer) | COVID-19 vaccine (Ad26.COV2-S) [recombinant] (Janssen Vaccine) | CDSCO/India | Emergency use authorisation granted for restricted use for the prevention of COVID-19 | 7 Aug 2021 | |
Finlay Institute, Cuba | Soberana 02 or Soberana 2, technical name FINLAY-FR-2, COVID-19 vaccine | Cuba | CECMED/ Cuba | Emergency Use approval granted. More information on the vaccine here. | July 2021.Exact date not available |
GlaxoSmithKline Inc | Sotrovimab Immune sera and immunoglobulins, for human use | Health Canada | Authorised for use in relation to the COVID-19 pandemic, in accordance with section 5 of the Interim Order | Resources for healthcare professionals and consumers | 30 Jul 2021 |
Regeneron Pharmaceuticals, Inc. | Monoclonal antibodies casirivimab and imdevimab (REGEN-COV) | FDA/US | Emergency Use Authorisation granted on 21 Nov 2020. Fact sheet for healthcare providers revised to address SARS-COV-2 variants on 18 March 2021. Fact Sheet for Healthcare Providers 3 June 2021 FDA recently issued significant updates to the EUA to include: 1) Authorised dosage is now 600 mg of casirivimab and 600 mg of imdevimab. 2) Addition of Subcut. route of administration when IV infusion is not feasible & would lead to delay in treatment. 3) Addition of new REGEN-COV co-formulated product in single vial. | On 30 July 2021 FDA revised the EUA authorising REGEN-COV for emergency use as post-exposure prophylaxis (prevention) for COVID-19 in adults and pediatric individuals (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death. | 30 July 2021 |
Eli Lilly and Company | baricitinib (Olumiant) | FDA/US | Emergency Use Authorisation granted on 19 Nov 2020 for use in combination with remdesivir | On 28 July 2021 , The EUA for baricitinib no longer requires baricitinib be used in combination with Veklury (remdesivir). fact sheet for health care providers | 28 July 2021 |
Bharat Biotech International Ltd. | Covaxin COVID-19 vaccine | ANVISA/Brazil | On 4 June 2021 Exceptional import authorised. To be used under specific conditions listed. | On 27 July, ANVISA decided to provisionally suspend the exceptional and temporary authorisation for import and distribution of the vaccine against Covid-19 Covaxin. | 27 Jul 2021 |
AstraZeneca K.K | COVID-19 Vaccine (ChAdOx1-S [recombinant]) Vaxzevria Intramuscular injection | PMDA/Japan | (Approval based on article 14-3 of the PMD Act i.e Special approval for emergency on 21 May 2021. | On 27 July 2021, precautions revised. | 27 Jul 2021 |
Eli Lilly and Compañía SA de CV | Combination of the drugs Bamlanivimab / Etesevimab | Cofepris/Mexico | Committee on New Molecules (CMN), and the Subcommittee for the Evaluation of Biotechnological Products (SEPB) issued a favourable opinion. This represents a step prior to authorisation for emergency use. | 26 Jul 2021 | |
Pfizer Australia Pty Ltd. | COVID-19 vaccine COMIRNATY | TGA/Australia | Provisional approval granted on 25 Jan 2021 Updated storage conditions approved on 13 Mar 2021 Supporting regulatory documents with updated Product information On 24 May 2021, more flexible storage conditions approved. This change extends the approved storage period of the unopened thawed vial at 2-8°C (i.e. in a normal refrigerator after taking out of deep-freeze conditions) at the point of use from five days up to one month (31 days). | On 23 July 2021, addition of safety information about myocarditis and pericarditis to Product Information. On 23 July 2021, provisional approval granted to include 12- 15 year age group. | 23 July 2021 |
Sanofi Pasteur | Vidprevtyn COVID-19 vaccine | EMA/EU | Rolling review commenced. | 20 July 2021 | |
Swedish Orphan Biovitrum AB (publ), Sweden | Kineret (anakinra) an immunosuppressant authorised since March 2002. | EMA/EU | EMA has started evaluating an application to extend the use of Kineret (anakinra) to include treatment of COVID-19 in adult patients with pneumonia who are at risk of developing severe respiratory failure. EMA will communicate on the outcome of its evaluation, which is expected by October 2021 unless supplementary information is needed. | 19 July 2021 | |
Janssen Biotech Inc. | Ad26.COV2.S viral vector vaccine | FDA/US | Emergency Use Authorisation granted on 27 Feb 2021 Factsheet for healthcare providers | On 13 July 2021, FDA announced revisions to the vaccine recipient and vaccination provider fact sheets for the Johnson & Johnson (Janssen) COVID-19 Vaccine to include information pertaining to an observed increased risk of Guillain-Barré Syndrome (GBS) following vaccination. | 13 July 2021 |
Pfizer/BioNTech | Coronavirus mRNA vaccine Comirnaty® (BNT162b2) | PMDA/Japan | Approval based on article 14-3 of the PMD Act i.e. Special approval for emergency on 14 February 2021 | On 7 July 2021, revision of precautions was applied. Further information available here. | 7 July 2021 |
Janssen | COVID-19 vaccine | Medsafe/New Zealand | Provisional approval granted | 7 Jul 2021 | |
Manufactured by Sinovac Life Sciences Co, and imported by Curanto Pharma (Pty) Ltd | CoronaVac COVID-19 vaccine Inactivated whole virion vaccine | SAHPRA/South Africa | Emergency use access under Section 21 of the Medicines and Related Substance Act 101 of 1965, subject to certain conditions. | 3 Jul 2021 | |
M/s Panacea Biotec Ltd | Gam COVID Vac (component I & II) (SPUTNIK-V) | CDSCO/India | Emergency use authorisation granted for restricted use for the prevention of COVID-19 | 2 Jul 2021 | |
M/s Cipla Ltd. (Importer) | mRNA-1273COVID-19 vaccine (Moderna vaccine) | CDSCO/India | Emergency use authorisation granted for restricted use for the prevention of COVID-19 | 29 Jun 2021 | |
Janssen-Cilag Pty Ltd. | Ad26.COV2.S viral vector vaccine | TGA/Australia | Provisional approval granted. | 25 Jun 2021 | |
Pfizer, Inc, / BioNTech | BNT162b2 mRNA vaccine | Cofepris/Mexico | Authorised for emergency use on 11 Dec 2020. | On 24 June 2021 modification to the authorisation conditions for emergency use of the expanding the therapeutic indication for its possible application from the age of 12 years. | 24 Jun 2021 |
Hoffmann-La Roche, Ltd. C/O Genentech, Inc. | Actemra (tocilizumab) Actemra is a monoclonal antibody. | FDA/US | Emergency Use Authorisation (EUA) Fact sheet for healthcare providers | EUA for the treatment of hospitalised adults and pediatric patients (2 years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). | 24 Jun 2021 |
China National Pharmaceutical Group | Sinopharm vaccine | SAHPRA/South Africa | SAHPRA has received documentation for the vaccine and will now commence with evaluating the data in assessing the efficacy of the vaccine. | 23 Jun 2021 | |
MODERNA BIOTECH SPAIN, S.L. | COVID-19 Vaccine Moderna mRNA-1273 vaccine | EMA/EU | Conditional marketing authorisation granted on 6 Jan 2021 Overview, Authorisation details, Product Information and assessment history Clinical data to support the authorisation, published 2 March 2021 | On 11 June 2021, the CHMP has approved a new manufacturing site for the production of Moderna COVID-19 vaccine finished product. The site, operated by Recipharm, is located in Monts, France. On 8 June 2021 EMA has started evaluating an application to extend the use of the COVID-19 Vaccine Moderna to include young people aged 12 to 17. | 11 Jun 2021 |
Gilead Sciences Ireland UC | Veklury (remdesivir) Concentrate for solution for infusion | EMA/EU | On 23 Feb 2021, EMA has started evaluating an application to extend the use of Veklury (remdesivir) to include treating adults with COVID-19 who do not require supplemental oxygen. EMA will communicate on the outcome of the evaluation, which is expected before the summer. 25 Jun 2020 Conditional marketing authorisation granted. | On 11 Jun 2021, the PRAC has recommended a change to the product information for Veklury to include sinus bradycardia (heart beats more slowly than usual) as an adverse reaction of unknown frequency for this medicine. On 21 May 2021 The CHMP recommended to renew the conditional marketing authorisation for Veklury (remdesivir), the only authorised antiviral treatment for COVID-19 | 11 Jun 2021 |
Hoffmann-La Roche Limited | Casirivimab and Imdevimab (monoclonal antibodies) | Health Canada | Authorised in accordance with section 5 of the Interim Order re COVID-19. Authorised with conditions | Resources for healthcare professionals | 9 Jun 2021 |
Developed by Russia’s Gamaleya National Centre of Epidemiology and Microbiology | Sputnik V (Gam-COVID-Vac), a COVID-19 vaccine | Anvisa/Brazil | The vaccine may be imported on an exceptional basis by Brazil, in specific quantities, for the purposes of distribution and use under controlled conditions determined by Anvisa. | 4 Jun 2021 | |
Moderna TX Inc. | Moderna COVID-19 Vaccine | FDA/US | Emergency Use Authorisation on 18 Dec 2020 Additional information including factsheets for healthcare providers and recipients | 1 Jun 2021 | |
Sinovac | Sinovac-CoronaVac COVID19 vaccine | World Health Organisation (WHO) | Emergency Use Listing (EUL) | On 1 June 2021 Moderna announced that it has has initiated the rolling submission process with the FDA for a Biologics License Application (BLA) for the licensure of its mRNA COVID-19 Vaccine to prevent COVID-19 in individuals 18 years of age and older. | 1 Jun 2021 |
Pfizer New Zealand Limited | Comirnaty COVID-1 mRNA vaccine | Medsafe/New Zealand | Approval under section 23 of the Medicines Act with conditions, 3 February 2021 Datasheet | On 28 May 2021, Medsafe has approved new storage conditions for use. This change means that the refrigerated (2°C to 8°C) shelf life of an unopened vial of Comirnaty vaccine is extended from 5 days to 31 days. | 28 May 2021 |
Pfizer/BioNTech | Coronavirus mRNA vaccine Comirnaty® (BNT162b2) | EMA/EU | Conditional Marketing Authorisation granted on 21 Dec 2020. Overview, Authorisation details, Product Information and assessment history On 26 March, CHMP gave a positive opinion to allow transportation and storage of vials of this vaccine at temperatures between -25 to -15˚C for a one-off period of two weeks. | 28 May 2021 EMA’s human medicines committee (CHMP) has recommended granting an extension of indication for the COVID-19 vaccine Comirnaty to include use in children aged 12 to 15. The vaccine is already approved for use in adults and adolescents aged 16 and above. On 17 May 2021, the EMA has recommended a change to the approved storage conditions of Comirnaty. This change extends the approved storage period of the unopened thawed vial at 2-8°C (i.e. in a normal fridge after taking out of deep-freeze conditions) from five days to one month (31 days). | 28 May 2021 |
Eli Lilly and Company | Investigational monoclonal antibody therapy sotrovimab | FDA/US | Emergency Use Authorisation granted. Healthcare providers factsheet. | 26 May 2021 | |
Pfizer-BioNTech | COVID-19 vaccine COMIRNATY | HSA singapore | Interim authorisation under PSAR route – 14 Dec 2020 HSA Extends the Use of Pfizer-BioNTech COVID-19 Vaccine to Adolescents of Ages 12 to 15 – 18 May 2021 | 25 May 2021 HSA Approves New Storage Condition at Refrigerator Temperature for up to 31 Days. | 25 May 2021 |
GlaxoSmithKline and Vir Biotechnology | Sotrovimab (VIR-7831) a monoclonal antibody | EMA/ EU | EMA has completed its review. The Agency concluded that sotrovimab can be used to treat confirmed COVID-19 in adults and adolescents (aged 12 years and above and weighing at least 40 kg) who do not require supplemental oxygen therapy and who are at risk of progressing to severe COVID-19. | 21 May 2021 | |
Moderna Inc. Applicant. Takeda Pharmaceutical Company Limited. | COVID-19 Vaccine Moderna Intramuscular Injection | PMDA/Japan | Approval based on article 14-3 of the PMD Act i.e Special approval for emergency | 21 May 2021 | |
Fiocruz / Astrazeneca | COVID-19 vaccine recombinant | ANVISA/Brazil | Full approval granted on 12 March 2021. Prescribing information and package leaflet in Portuguese | On 10 May 2021, ANVISA recommended the immediate suspension of the use of the Covid vaccine from AstraZeneca/Fiocruz in pregnant women | 10 May 2021 |
Janssen-Cilag, SA de CV | COVID-19 AD26.COV2.S vaccine | Cofepris/Mexico | Emergency Use Authorisation granted. | 7 May 2021 | |
Beijing Bio-Institute of Biological Products Co Ltd, a subsidiary of China National Biotec Group (CNBG). | Sinopharm COVID-19 vaccine ((Vero Cell) | World Health Organisation (WHO) | Emergency Use Listing (EUL) | 7 May 2021 | |
GlaxoSmithKline and Vir Biotechnology | Sotrovimab (VIR-7831) a monoclonal antibody | EMA/EU | EMA has started a ‘rolling review’ of data on sotrovimab | 7 May 2021 | |
Developed by Sinovac Life Sciences Co., Ltd. The EU applicant is Life’On S.r.l. | COVID-19 Vaccine (Vero Cell) Inactivated | EMA/EU | The EMA has commenced a rolling review of this vaccine and this will continue until until enough evidence is available for a formal marketing authorisation application. | 4 May 2021 | |
Moderna | Moderna COVID-19 vaccine (mRNA 1273) | World Health Organisation (WHO) | Emergency Use Listing (EUL) | 30 Apr 2021 | |
SK Bioscience | Novavax COVID-19 vaccine | MFDS/Republic of Korea | MFDS Begins Rolling Review of Novavax COVID-19 Vaccine | 29 Apr 2021 | |
Huons Co., Ltd | Sputnik V COVID-19 vaccine | MFDS/Republic of Korea | MFDS Begins Rolling Review of Sputnik V COVID-19 Vaccine | 29 Apr 2021 | |
Eli Lilly Nederland B.V. | Olumiant (baricitinib) Olumiant is an immunosuppressant | EMA/EU | EMA has started evaluating an application to extend the use of Olumiant (baricitinib) to include treatment of COVID-19 in hospitalised patients from 10 years of age who require supplemental oxygen. Olumiant was first authorised in the EU in February 2017 | 29 Apr 2021 | |
Eli Lilly Canada Inc | Monoclonal antibody Bamlanivimab | Health Canada | Authorised in accordance with section 5 of the Interim Order re COVID-19 on 20 Nov 2020 Resources for healthcare professionals and consumers | 28 Apr 2021 Potential Risk of Treatment Failure Due to Circulation of Resistant SARS-CoV-2 Variants identified. | 28 Apr 2021 |
Eli Lilly Japan K.K. | Baricitinib- Olumiant Tablets 2 mg / Olumiant Tablets 4 mg | PMDA/Japan | Approval details | 23 Apr 2021 | |
Roche Pharma (Switzerland) AG | casirivimab and imdevimab, the active substances contained in “RegN-Cov2”, an artificial antibody cocktail that was developed to produce resistance to the SARS-Cov-2 coronavirus | Swissmedic | Swissmedic has given the go-ahead for the distribution of “RegN-Cov2“, a concentrate for solution for infusion from Roche Pharma (Switzerland) AG. As a result, this medicinal product is available even before the authorisation decision has been taken. The above has been facilitated under Annex 5 of COVID-19 Ordinance 3 lists those active substances that may be placed on the market before the authorisation procedure is concluded, provided Swissmedic has received an authorisation application. The required authorisation application has been submitted to Swissmedic by Roche. | 20 Apr 2021 | |
CureVac Swiss AG | COVID-19 vaccine candidate CVnCoV | Swissmedic | Rolling review commenced. | 19 Apr 2021 | |
Eli Lilly and Company | Monoclonal antibody bamlanivimab | FDA/US | Emergency Use Authorisation granted on 9 Nov 2020 | Emergency use authorisation revoked on 16 April 2021. Link to FDA letter to Eli Lilly and Company. | 16 Apr 2021 |
GSK | Monoclonal antibody VIR-7831 (also known as GSK4182136) | EMA/EU | EMA starts review of VIR-7831 for treating patients with COVID-19. This review is being undertaken to support national authorities who may decide on the use of this medicine for COVID-19 prior to marketing authorisation. | 15 Apr 2021 | |
Janssen-Cilag Farmacêutica Ltda | COVID-19 vaccine | ANVISA/Brazil | Temporary authorisation for emergency use granted on 31 March 2021. | On 14 April 2021, approval of increased shelf life from three to four and a half months under conditions of storage at 2 °C to 8 ° C. | 14 April 2021 |
AstraZeneca AB | Vaxzevria – COVID-19 Vaccine (ChAdOx1-S [recombinant]) | EMA/EU | Conditional marketing authorisation granted on 29 Jan 2021. Overview, authorisation details, Product information and assessment history. | 14 April 2021 EMA continues to monitor very rare blood clots with low blood platelets that occurred after vaccination with Vaxzevria (previously COVID-19 Vaccine AstraZeneca). In line with a request from the EU’s Commissioner for Health and Food Safety following a meeting of EU Health Ministers, EMA is undertaking a review of vaccination data and data on disease epidemiology (including infection rates, hospitalisations, morbidity and mortality). | 14 Apr 2021 |
Russian Direct Investment Fund (RDIF) partnered with Dr. Reddy’s Laboratories Ltd. | Gam COVID Vac (component I & II) (SPUTNIK-V | CDSCO/India | Emergency use authorisation granted for restricted use for the prevention of COVID-19 | 12 Apr 2021 | |
Green Cross Corporation | Moderna COVID-19 vaccine | MFDS/Republic of Korea | Review of marketing authorisation application in progress. | 12 Apr 2021 | |
AstraZeneca Pty Ltd. | ChAdOx1-S [recombinant] viral vector vaccine | TGA/Australia | Provisional approval granted on 16 Feb 2021 Supporting regulatory documents updated on 8 April 2021 to include the latest information about the risk of very rare cases of thrombosis (blood clots) with thrombocytopenia (low blood platelet count) as per this update. | TGA approves CSL-Sequirus to manufacture the AstraZeneca vaccine in Australia on 21 March 2021 | 8 Apr 2021 |
Janssen Korea | Janssen COVID-19 vaccine | MFDS/Republic of Korea | Marketing authorisation granted. | 7 Apr 2021 | |
Bharat Biotech International Limited, India | Covaxin vaccine | Cofepris/ Mexico | Emergency Use Authorisation granted. | 6 Apr 2021 | |
Janssen Pharmaceutica (Pty) Ltd. | COVID-19 VACCINE JANSSEN (AD26.COV2-S) | SAHPRA/South Africa | Registered under Section 15(6a) of the Medicines and Related Substance Act 101 of 1965, with conditions | 1 April 2021 | |
Janssen-Cilag AG | Ad26.COV2.S viral vector vaccine | Swissmedic | Temporary authorisation granted. | 22 Mar 2021 | |
Janssen (Johnson & Johnson) | COVID-19 vaccine Ad26.COV2.S, | World Health Organsiation (WHO) | Emergency Use Listing (EUL) | 12 Mar 2021 | |
Janssen Inc | Ad26.COV2.S viral vector vaccine | Health Canada | Authorised in accordance with section 5 of the interim order. | Resources for healthcare professionals and consumers. | 5 Mar 2021 |
Pfizer Korea | COVID-19 vaccine, COMIRNATY Inj | MFDS/Republic of Korea | Marketing authorsation granted. | 5 Mar 2021 | |
R-Pharm Germany GmbH | Sputnik V (Gam-COVID-Vac), a COVID-19 vaccine | EMA/EU | Rolling review commenced | 4 Mar 2021 | |
Verity Pharmaceuticals Inc. and Serum Institute of India (SII) (in in partnership with AstraZeneca Canada Inc.#0 | Covishield ChAdOx1-S (recombinant) | Health Canada | Authorised in accordance with section 5 of the Interim Order | Resources for Healthcare professionals and consumers | 26 Feb 2021 |
AstraZeneca Canada Inc | AstraZeneca COVID-19 Vaccine ChAdOx1-S (recombinant) | Health Canada | Authorised in accordance with section 5 of the Interim Order | Resources for Healthcare professionals and consumers | 26 Feb 2021 |
AstraZeneca-SKBio (Republic of Korea) | Astrazeneca ChAdOx1-S [recombinant] vaccine | World Health Organisation (WHO) | Emergency Use Listing (EUL) | This is a version of the Astrazeneca vaccine | 15 Feb 2021 |
Serum Institute of India | Astrazeneca ChAdOx1-S [recombinant] vaccine | World Health Organisation (WHO) | Emergency Use Listing (EUL) | This is a version of the Astrazeneca vaccine | 15 Feb 2021 |
Gilead Sciences Ireland UC | Veklury (remdesivir) Concentrate for solution for infusion | EMA/EU | 25 Jun 2020 Conditional marketing authorisation granted. | 12 Feb 2021 PRAC concludes product not associated with kidney disease and starts new safety signal procedure for sinus bradycardia. | 12 Feb 2021 -PRAC news |
AstraZeneca Korea | Korea AstraZeneca COVID-19 Vaccine Inj | MFDS/Republic of Korea | Marketing authorisation granted. | 10 Feb 2021 | |
Sinovac Research and Development | CoronaVac Inactive Virus vaccine | Cofepris/Mexico | Authorised for emergency use. | 9 Feb 2021 | |
CanSino Biologics Inc | Ad5-nCoV Non-replicating viral vector vaccine | Cofepris/Mexico | Authorised for emergency use. | 9 Feb 2021 | |
Gamaleya Institute | Sputnik V Non-replicating viral vector vaccine | Cofepris/Mexico | Authorised for emergency use. | 9 Feb 2021 | |
Celltrion Inc. | recombinant neutralising antibody regdanvimab (Regkirona Injection 960mg) | MFDS/Republic of Korea | Marketing Authorisation granted with conditions. | 5 Feb 2021 | |
Moderna | Moderna COVID-19 vaccine | HSA/Singapore | Interim authorisation under PSAR route. | 3 Feb 2021 | |
Novavax CZ AS (a subsidiary of Novavax, Inc.) | NVX-CoV2373 a COVID-19 vaccine | EMA/EU | Rolling review commenced | 3 Feb 2021 | |
Astrazeneca | COVID-19 Vaccine (ChAdOx1 S [recombinant]) | Swissmedic | Rolling review ongoing. | Swissmedic has requested additional data. | 3 Feb 2021 |
Taw pharma | Corticosteroid Dexamethasone TAW | EMA/EU | Withdrawn | Taw pharma withdrew the MA application on 20 January 2021 because it was unable to remove preservatives from the medicine within the timeframe required by EMA. | 29 Jan 2021 |
Sinovac Life Sciences Co., LTD (China) | Coronavac vaccine | ANVISA/Brazil | Temporary authorsation for emergency use granted. | 22 Feb 2021 | |
Sinovac in partnership with the Butantan Institute | CoronaVac vaccine, | ANVISA/Brazil | First temporary authorisation for the emergency use approved on 17 January 2021. | On 22 January 2021, second temporary authorisation for the emergeny use appoved. | 22 Jan 2021 |
COVISHIELD an Adenovirus- Vectored COVID-19 vaccine manufactured by the Serum Institute of India | SAHPRA/ South Africa | Section 21 Authorisation granted. | 22 Jan 2021 | ||
Biocelect Pty Ltd (on behalf of Novavax Inc | COVID-19 Vaccine, NVX-CoV2373 | TGA/Australia | Provisional determination granted | 20 Jan 2021 | |
MODERNA BIOTECH SPAIN, S.L. | COVID-19 Vaccine Moderna mRNA-1273 vaccine | EMA/EU | Conditional marketing authorisation granted Clinical data to support the authorisation, published | Overview, Authorisation details, Product Information and assessment history | 6 Jan 2021 |
AstraZeneca /Oxford University | AZD1222 Adenovirus vaccine | Cofepris/Mexico | Authorised for emergency use. | 4 Jan 2021 | |
M/s Bharat Biotech, India | Whole-Virion Inactivated SARSCoV-2 Vaccine (COVAXIN) | CDSCO/India | Emergency use authorisation granted for restricted use for the prevention of COVID-19 | 3 Jan 2021 | |
M/s Serum Institute of India Pvt. Ltd. | ChAdOx1 nCoV-19 Corona Virus vaccine Recombinant) (COVISHIELD) | CDSCO/India | Emergency use authorisation granted for restricted use for the prevention of COVID-19 | 3 Jan 2021 | |
Pfizer/BioNTech | Coronavirus mRNA vaccine Comirnaty® | World Health Organisation (WHO) | Emergency Use Listing (EUL) | Recommendation for EUL + product insert | 31 Dec 2020 |
Moderna Therapeutics Inc. | Moderna COVID-19 Vaccine mRNA-1273 SARS-CoV-2 | Health Canada | Authorised in accordance with section 5 of the Interim Order re COVID-19 Clinical data to support the authorisation, published | Resources for healthcare professionals and consumers | 23 Dec 2020 |
Dr Reddys Laboratories Ltd | Favipiravir | Health Canada | Under review | 18 Dec 2020 | |
BioNTech Manufacturing GmbH | Tozinameran Pfizer-BioNTech COVID-19 Vaccine mRNA vaccine, BNT162b2 | Health Canada | Authorised in accordance with section 5 of the Interim Order re COVID-19 | Resources for healthcare professionals and consumers | 9 Dec 2020 |
Janssen Inc | Ad26.COV2.S viral vector vaccine | Health Canada | Under review | 30 Nov 2020 | |
Gilead Sciences Inc. | Veklury (remdesivir) for injection, for intravenous use | FDA/US | Approved via fast track and priority review | Prescribing information | 22 Oct 2020 |
AstraZeneca Canada Inc. | COVID-19 Vaccine AstraZeneca (ChAdOx1 S [recombinant]) | Health Canada | Under review | 1 Oct 2020 | |
Various | Corticosteroid Dexamethasone | EMA/EU | Reviewed under Article 5(3) of Regulation 726/2004 and endorsed for use. | 18 Sep 2020 | |
US Dept. of Health and Human Services (HHS) | COVID-19 Convalescent Plasma (CCP) | FDA/US | Emergency Use Authorisation | Fact sheet for healthcare providers | 23 Aug 2020 |
Gilead Sciences Canada Inc. | Veklury (remdesivir) solution for injection | Health Canada | Notice of compliance issued Issued under Notice of Compliance with conditions guideline | Resources for healthcare professionals and consumers | 27 July 2020 |
Gilead Sciences Ireland UC | Veklury (remdesivir) Concentrate for solution for infusion | EMA/EU | Conditional marketing authorisation granted. | Overview, Authorisation details, Production Information and assessment history | 25 Jun 2020 |
Gilead Sciences, Inc | Remdesivir | PMDA/Japan | Approval based on article 14-3 of the PMD Act i.e Special Approval for Emergency | 8 May 2020 |
Photo by Daniel Schludi on Unsplash