COVID-19
COVID-19 medicines that received EMA advice
During the COVID-19 pandemic, the European Medicines Agency (EMA) interacted with developers of potential COVID-19 vaccines and treatments to enable their distribution in the European Union (EU) as soon as possible.
The outcome of any consultation or advice from EMA was not binding on developers.
EMA published the information on this page for use during the COVID-19 public health emergency. EMA is no longer updating this page. |
Product | Developer | Development stage at time of guidance |
---|---|---|
Ad26.COV2.S | Janssen-Cilag International N.V. | Non-clinical phase |
Ad5-nCoV vaccine | Cansino Biotech | Clinical phase |
Adjuvanted whole virion inactivated vaccine | Sinovac Life Sciences Co | Non-clinical phase |
ChAdOx1-SARS-CoV-2 | Vaccitech/AstraZeneca | Clinical phase |
Coronavirus-like particle (COVLP) | Medicago | Non-clinical phase |
CVnCoV, CV07050101 vaccine | Curevac | Non-clinical phase |
Herpes simplex virus vector tetravalent SARS-CoV-2 vaccine | Krystal Bio | Non-clinical phase |
LNP-saRNA CoVid19 vaccine | VacEquity Global Health/Imperial College London | Clinical phase |
LUNAR-COV19 mRNA vaccine | Arcturus Therapeutics | Clinical phase |
mRNA SARS-CoV-2 vaccine | Biontech | Non-clinical phase |
mRNA-1273 SARS-CoV-2 vaccine | Moderna | Non-clinical phase |
MV-SARS-CoV-2 vaccine | Themis Bioscience GmbH/Merck Sharp & Dohme (MSD) | Non-clinical phase |
NVX-CoV-2 rS | Novavax | Non-clinical phase |
Protein nanoparticle vaccine | Emergex Vaccines Holding Ltd | Non-clinical phase |
rVSVΔG-SARS-CoV-2 live attenuated | Merck Sharp & Dohme (MSD)/IAVI | Non-clinical phase |
SARS-CoV-2 DNA vaccine | Inovio | Non-clinical phase |
SARS-Cov-2 vaccine | Queensland University/Seqirus/CSL | Non-clinical phase |
SARS-CoV-2 vaccine recombinant, adjuvanted | Sanofi Pasteur | Non-clinical phase |
S-trimer subunit vaccine | Clover Biopharma | Clinical phase |
Subunit vaccine adjuvanted MVC-COV1901 | Medigen | Non-clinical phase |
VLA 2001 vaccine | Valneva | Non-clinical phase |
Protein vaccine adjuvanted | Kentucky Bioprocessing, Inc | Non-clinical phase |
DNA Plasmid vaccine | Takis S.r.l., Rottapham Biotech | Non-clinical phase |
Gam-COVID-Vac | The Gamaleya National Centre of Epidemiology and Microbiology | Clinical phase |
MRT5500 mRNA vaccine | Sanofi / Translate Bio | Non-clinical phase |
PB-206 | HIPRA | Non-clinical phase |
UB-612 | Vaxxinity (Covaxx) / UBI (United Biomedical, Inc.) | Clinical phase |
MVA-SARS-2-S and MVA-SARS-2-ST | IDT-Biologika / German Center for Infection Research (DZIF) | Clinical phase |
GBP510 | Sk Bioscience Co. Ltd | Clinical phase |
FINCoVac 2.0 vaccine | Rokote Laboratories Finland Oy | Non-clinical phase |
GRAd-COV2 | Reithera S.r.l. | Clinical phase |
GSK&CV SARS-COV-2 vaccine (2nd generation) | GSK and CureVac | Clinical phase |
Prime‐2‐CoV | Speransa Therapeutics | Clinical phase |
Vaxzevria-AZD-2816 | AstraZeneca | Clinical phase |
RVX-13 | RocketVax AG | Non-clinical phase |
ABNCoV2 | Bavarian Nordic AS | Clinical phase |
VB10.2210 | Nykode Therapeutics | Clinical phase |
PHH-1V | Laboratorios HIPRA S.A. | Clinical phase |
ISR52 | ISR Vaccine AB | Non-clinical phase |
INO-4800 | Inovio | Clinical phase |
ARCT-154 | Arcturus Therapeutics Europe B.V. | Clinical phase |
Ad5-nCoV-IH | Cansino Biotech | Clinical phase |
MVC-COV1901 | Medigen Vaccine Biologics Corp. | Clinical phase |
Dellera, mRNA vaccine | Fondo Ricerca Medica S.r.l. | Clinical phase |
CV0501 | CureVac and GSK | Clinical phase |
COVI-Liv | Bilthoven Biologicals B.V. | Clinical phase |
CD40.RBDv, CD40.Pan.CoV | LinKinVax | Non-clinical phase |
MVA-CoV2-S(3P) | Biofabri S.L. | Non-clinical phase |
Last updated 6 October 2022
This information should not be read as an endorsement of any medicine
Product | Developer | Therapeutic class/drug type | Development stage at time of guidance |
---|---|---|---|
A64-DP | BCN Peptides SA | Immunomodulator | Non-clinical phase |
Acalabrutinib | Acerta Pharma BV / AstraZeneca | Immunomodulator | Clinical phase |
Anti-SARS-CoV-2 polyclonal hyperimmune immunoglobulin | Alliance hyperimmune project (Biotest AG, Bio Products Laboratory, LFB, Octapharma, CSL Behring and Takeda) | Antiviral | Clinical phase |
APN01 | Apeiron Biologics | Immunomodulator | Clinical phase |
Apremilast | Amgen Europe BV | Immunomodulator | Clinical phase |
AZD7442 | AstraZeneca | Antiviral (monoclonal antibody) | Non-clinical phase |
Baricitinib | Eli Lilly | Immunomodulator | Clinical phase |
CD24Fc | Oncoimmune Inc | Immunomodulator | Clinical phase |
CHAG-COVID19-CA | ChimAgents | Challenge agent for human infection models | Non-clinical phase |
Chloroquine | Oxford University | Other therapeutic | Clinical phase |
Chloroquine and hydroxychloroquine cyclops DPI | PureIMS | Other therapeutic | Clinical phase |
Copper chloride | ACOM | Antiviral | Clinical phase |
CT-P59 | Celltrion | Antiviral (monoclonal antibody) | Non-clinical phase |
Danoprevir | Ascletis Pharmaceuticals Co Ltd | Antiviral | Clinical phase |
Eculizumab | Alexion | Immunomodulator | Clinical phase |
Emapalumab and anakinra | Swedish Orphan Biovitrum AB (SOBI) | Immunomodulator | Clinical phase |
FAV00B | Farmak International Holding GmbH | Antiviral | Non-clinical phase |
Favipiravir | Glenmark Pharmaceuticals Ltd | Antiviral | Clinical phase |
Gimsilumab | Roivant | Immunomodulator | Clinical phase |
Kamada Anti-SARS-CoV-2 | Kamada Ireland Ltd | Immunoglobulin | Non-clinical phase |
Larifan Plus | Auramed Ltd | Antiviral | Non-clinical phase |
LY-CoV555 (LY3819253) and LY-CoV016 (LY3832479) | Eli Lilly | Antiviral (monoclonal antibody) | Non-clinical phase |
M5049 | Merck Healthcare | Immunomodulator | Non-clinical phase |
Mavrilimumab | Kiniksa Pharmaceuticals | Immunomodulator | Clinical phase |
Meplazumab | Jiangsu Pacific Meinuoke Biopharmaceutical Co Ltd | Antiviral (monoclonal antibody) | Clinical phase |
MK-4482 | Ridgeback Biotherapeutics LP/Merck Sharp & Dohme (Europe) Inc | Antiviral | Non-clinical phase |
Otilimab | GSK | Immunomodulator | Clinical phase |
PF-07304814 | Pfizer | Antiviral | Non-clinical phase |
Raloxifene | Dompé | Antiviral | Non-clinical phase |
Ravulizumab | Alexion | Other therapeutics | Clinical phase |
RBT-9 | Renibus Therapeutics Inc | Antiviral | Clinical phase |
REGN10933, REGN10987, REGN10989 | Regeneron UK | Antiviral (monoclonal antibody) | Non-clinical phase |
Remdesivir | Gilead | Antiviral | Clinical phase |
RESP301 | Thirty Respiratory Limited (30 Technology) | Antiviral | Non-clinical phase |
Sarilumab | Sanofi Aventis | Immunomodulator | Clinical phase |
Siltuximab | EUSApharma | Immunomodulator | Clinical phase |
Tocilizumab | Roche | Immunomodulator | Clinical phase |
UNI911 | Union Therapeutics | Antiviral | Clinical phase |
VIR-7831, VIR-7832 | Vir Biotechnology/GSK | Antiviral (monoclonal antibody) | Clinical phase |
SNG001 | Synairgen Research Limited | Immunomodulator | Clinical phase |
VRP-033 | Venus Pharma GmbH | Immunomodulator | Non-clinical phase |
BRII-196, BRII-198 | Brii Biosciences | Antiviral (monoclonal antibody) | Non-clinical phase |
SCTA01 | Sinocelltech Ltd. | Antiviral (monoclonal antibody) | Clinical phase |
Itolizumab | Biocon Biologics Limited | Immunomodulator | Clinical phase |
BI 764198 | Boehringer Ingelheim International GmbH | Other therapeutic | Clinical phase |
4P021 | 4P-Pharma | Antiviral | Non-clinical phase |
Masitinib mesylate | AB Science | Antiviral | Non-clinical phase |
EX-14870 | Boehringer Ingelheim International BmBH | Antiviral | Non-clinical phase |
2-DEOXY-D-GLUCOSE | Dermin Sp. Z.0.0 | Other therapeutic | Non-clinical Phase Clinical phase |
Emiplacel | Biopharma Excellence GmbH | Other therapeutic | Clinical phase |
AT-527 | Roche | Antiviral | Clinical phase |
ABBV-47D11 | AbbVie | Antiviral | Clinical phase |
Aviptadil | Relief Therapeutics Holding S.A | Other therapeutic | Clinical phase |
AR-711 | Aridis Pharmaceuticals, Inc. | Antiviral (monoclonal antibody) | Non-clinical phase |
Colchicine | Pharmascience Inc. (PMS) / Montreal Health Institute (MHI) | Immunomodulator | Clinical phase |
CoviFab | Inmunova S.A. / mAbxience | Antiviral | Clinical phase |
Trimodulin (human IgM, IgA, IgG solution) | Biotest AG | Immunomodulator | Clinical phase |
MK-7110 | Merck Sharp & Dohme (MSD) / Merck & Co. | Immunomodulator | Clinical phase |
Camostat | Daewoong | Antiviral | Clinical phase |
Bemcentinib | BergenBio | Antiviral | Clinical phase |
Vidofludimus calcium (IMU–838) | Immunic AG | Immunomodulator / Antiviral | Clinical phase |
Vilobelimab | InflaRx GmbH | Immunomodulator | Clinical phase |
FBR-002 | Fab'entech | Antiviral (monoclonal antibody) | Clinical phase |
BMS986414 and BMS986413 | Rockefeller University and Bristol Myers Squibb | Antiviral (monoclonal antibody) | Clinical phase |
Proxalutamide | Suzhou Kintor Pharmaceuticals / Applied Biology | Other therapeutic | Clinical phase |
Calcifediol | Vifor Fresenius Medical Care Renal Pharma France | Other therapeutic | Clinical phase |
Lenzilumab | Humanigen | Immunomodulator | Clinical phase |
Azelastine | Ursapharm | Immunomodulator | Clinical phase |
Opaganib hydrochloride | RedHill Biopharma | Other therapeutic | Clinical phase |
MAD0004J08 | Menarini Ricerche S.p.A. | Antiviral (monoclonal antibody) | Clinical phase |
C21 | Vicore Pharma | Immunomodulator | Clinical phase |
nezulcitinib | Theraevance Biopharma | Immunomodulator | Clinical phase |
Imlifidase (Idefirix) | Hansa Biopharma AB | Immunomodulator | Clinical phase |
WP 1122 | Wpd Pharmaceuticals Sp z o.o | Other therapeutic | Non clinical phase |
RGB-22 | Chemical Works Of Gedeon Richter PLC | Antiviral | Non-clinical phase |
XAV-19 | Xenothera | Antiviral | Clinical phase |
Imatinib Mesilate | Exvastat | Immunomodulator | Clinical phase |
PF-07321332 | Pfizer | Antiviral | Clinical phase |
Fostamatinib | Rigel | Immunomodulator | Clinical phase |
ADG20 | Adagio Therapeutics | Immunomodulator | Clinical phase |
Interferon alfa (INF-alpha), chimeric | Genova Inc | Other therapeutic | Non-clinical phase |
XVR011 | Exevir Bio | Antiviral | Clinical phase |
N,N’-bis[2-(1H-imidazol-2-yl)ethyl]pentanediamide | Treamid GmbH | Immunomodulator | Clinical phase |
S-217622B | Shionogi B.V. | Antiviral | Clinical phase |
CYCLOBENZAPRINE HYDROCHLORIDE | M-Squared Consulting S.r.l. | Other therapeutic | Clinical phase |
F004 | HWI Analytik GmbH | Antiviral | Non-clinical phase |
XC221GI | Valenta Pharmaceuticals JSC | Antiviral | Clinical phase |
RMD-101 | Remedy Biologics Limited | Antiviral | Non-clinical phase |
PRO75 | Evotec International GmbH | Antiviral (monoclonal antibody) | Non-clinical phase |
Reparixin | Dompé farmaceutici s.p.a | Immunomodulator | Clinical phase |
Ensovibep | Novartis | Antiviral | Clinical phase |
Ivermectin | Hwi Pharma Services GmbH | Antiviral | Clinical phase |
HH-120 | Huahui Health Ltd. | Antiviral | Clinical phase |
ASUNERCEPT | Apogenix AG | Immunomodulator | Clinical phase |
Regdanvimab | Celltrion Healthcare Hungary Kft. | Antiviral (monoclonal antibody) | Clinical phase |
Plitidepsin | Pharma Mar, S.A. | Antiviral | Clinical phase |
Ronapreve | Regeneron | Antiviral (monoclonal antibody) | Clinical phase |
Cetylpyridinium chloride | Veristat Spain S.L. | Antiviral | Clinical phase |
Olokizumab | R-Pharm CJSC | Antiviral (monoclonal antibody) | Clinical phase |
Aprotinin | Gerencia De Atención Integrada De Ciudad Real | Antiviral | Clinical phase |
Niclosamide nasal spray | Union Therapeuthics | Antiviral | Clinical phase |
AZD7518 (AZD3152, AZD3959) | AstraZeneca AB | Antiviral (monoclonal antibody) | Clinical phase |
Sabizabulin | Veru Inc. | Antiviral | Clinical phase |
TATX-03 (21-F2, 22-F7, 23-H7, 2-A6) | Talem Therapeutics LLC | Antiviral (monoclonal antibody) | Clinical phase |
GS-5245 | Gilead Sciences Ireland Unlimited Company | Antiviral | Clinical phase |
SPK001 | SpikImm | Antiviral (monoclonal antibody) | Clinical phase |
BC 007 (GS 522 or ARC183) | Berlin Cures | Immunomodulator | Clinical phase |
Arylacenamide | Meletios Therapeutics | Antiviral and immunomodulator | Clinical phase |
MK-7845 | Merck | Antiviral | Non-clinical phase |
Bemnifosbuvir hemisulfate | Atea Pharmaceuticals Inc | Antiviral | Clinical phase |
ALG-097558 | Aligos Belgium BV | Antiviral | Non-clinical phase |
Last updated 6 October 2022
This information should not be read as an endorsement of any medicine