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Opinion/decision on a Paediatric investigation plan (PIP): Vaxzevria (previously COVID-19 Vaccine AstraZeneca), COVID-19 vaccine (ChAdOx1-S [recombinant]) (AZD1222)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-002862-PIP01-20-M01, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 07/07/2021, Last updated: 18/07/2022, Compliance check: XEMEA-002862-PIP01-20-M01 Vaccines … name Vaxzevria (previously COVID-19 Vaccine AstraZeneca) Active substance … AstraZeneca) Active substance COVID-19 vaccine (ChAdOx1-S [recombinant … -
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Human medicine European public assessment report (EPAR): Vaxzevria (previously COVID-19 Vaccine AstraZeneca)
ChAdOx1-SARS-COV-2, COVID-19 virus infection
Date of authorisation: 29/01/2021,
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, Revision: 25, Authorised, Last updated: 30/11/2022
Vaxzevria (previously COVID-19 Vaccine AstraZeneca) Myelitis Respiratory … Diseases Respiratory Tract Diseases COVID-19 virus infection … Vaxzevria (previously COVID-19 Vaccine AstraZeneca … -
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Direct healthcare professional communication (DHPC): Vaxzevria (previously COVID-19 Vaccine AstraZeneca): link between the vaccine and the occurrence of thrombosis in combination with thrombocytopenia
Active substance: ChAdOx1-SARS-COV-2, DHPC type: Safety signal, Last updated: 13/04/2021Vaxzevria (previously COVID-19 Vaccine AstraZeneca): link between … AstraZeneca): link between the vaccine and the occurrence of thrombosis … combination with thrombocytopenia COVID-19 virus infection … -
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Direct healthcare professional communication (DHPC): Vaxzevria (previously COVID-19 Vaccine AstraZeneca): contraindication in individuals with previous capillary leak syndrome
Active substance: ChAdOx1-SARS-COV-2, DHPC type: Safety signal, Last updated: 23/06/2021Vaxzevria (previously COVID-19 Vaccine AstraZeneca): contraindication … capillary leak syndrome COVID-19 virus infection … Vaxzevria (previously COVID-19 Vaccine AstraZeneca): contraindication … -
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Direct healthcare professional communication (DHPC): Vaxzevria/COVID-19 Vaccine AstraZeneca: Risk of thrombosis in combination with thrombocytopenia - Updated information
Active substance: ChAdOx1-SARS-COV-2, DHPC type: Type II variation, Last updated: 02/06/2021Vaxzevria/COVID-19 Vaccine AstraZeneca: Risk of thrombosis … thrombocytopenia - Updated information COVID-19 virus infection … Vaxzevria/COVID-19 Vaccine AstraZeneca: Risk of thrombosis … -
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Direct healthcare professional communication (DHPC): Vaxzevria (previously COVID-19 Vaccine AstraZeneca): risk of thrombocytopenia (including immune thrombocytopenia) with or without associated bleeding
Active substance: ChAdOx1-SARS-COV-2, DHPC type: Safety signal, Last updated: 13/10/2021Vaxzevria (previously COVID-19 Vaccine AstraZeneca): risk of thrombocytopenia … without associated bleeding COVID-19 virus infection … Vaxzevria (previously COVID-19 Vaccine AstraZeneca): risk of thrombocytopenia … -
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Direct healthcare professional communication (DHPC): Vaxzevria (previously COVID-19 Vaccine AstraZeneca): Risk of thrombocytopenia and coagulation disorders
Active substance: Chimpanzee Adenovirus encoding the SARS CoV 2 Spike glycoprotein (ChAdOx1-S), DHPC type: Safety signal, Last updated: 24/03/2021Vaxzevria (previously COVID-19 Vaccine AstraZeneca): Risk of thrombocytopenia … and coagulation disorders COVID-19 virus infection … Vaxzevria (previously COVID-19 Vaccine AstraZeneca): Risk of thrombocytopenia … -
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Human medicine European public assessment report (EPAR): Jcovden (previously COVID-19 Vaccine Janssen) (updated)
adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S), COVID-19 virus infection
Date of authorisation: 11/03/2021,, , Revision: 27, Authorised, Last updated: 10/01/2023
Jcovden (previously COVID-19 Vaccine Janssen) Infections Respiratory … Diseases Lung Diseases Pneumonia COVID-19 virus infection … Authorised patient safety COVID-19 vaccine (Ad26.COV2-S [recombinant … -
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Human medicine European public assessment report (EPAR): COVID-19 Vaccine (inactivated, adjuvanted) Valneva
SARS-CoV-2 virus (inactivated) Wuhan strain hCoV-19 / Italy / INMI1-isl / 2020, COVID-19 virus infection
Date of authorisation: 24/06/2022,, Revision: 4, Authorised, Last updated: 05/12/2022
COVID-19 Vaccine (inactivated, adjuvanted … Diseases Respiratory Tract Diseases COVID-19 virus infection … Authorised COVID-19 vaccine (inactivated, adjuvanted … -
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Withdrawal from the rolling review process: CureVac’s COVID-19 vaccine (CVnCoV)
COVID-19 mRNA vaccine, date of withdrawal: 11/10/2021, Initial authorisation, Last updated: 21/10/2021CureVac’s COVID-19 vaccine (CVnCoV): Withdrawn applicati … CureVac’s COVID-19 vaccine (CVnCoV): Withdrawal from … rolling review for CureVac’s COVID-19 vaccine (CVnCoV) EMA has ended … -
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Opinion/decision on a Paediatric investigation plan (PIP): COVID-19 vaccine (Ad26.COV2-S (recombinant))
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Infectious diseases
PIP number: EMEA-002880-PIP01-20, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection in cartridge
Decision date: 05/02/2021, Last updated: 16/02/2021, Compliance check: XKey facts COVID-19 vaccine (Ad26.COV2-S (recombinant … Coronavirus disease 2019 (COVID-19) Intramuscular use Janssen-Cilag … granting of a deferral for COVID-19 … -
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Direct healthcare professional communication (DHPC): COVID-19 Vaccine Janssen: link between the vaccine and the occurrence of thrombosis in combination with thrombocytopenia
Active substance: adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S), DHPC type: Safety signal, Last updated: 26/04/2021COVID-19 Vaccine Janssen: link between the vaccine and the occurrence of thrombosis … combination with thrombocytopenia COVID-19 virus infection … COVID-19 Vaccine Janssen: link between the vaccine and the occurrence of thrombosis … -
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Direct healthcare professional communication (DHPC): COVID-19 Vaccine Janssen: Risk for immune thrombocytopenia (ITP) and venous thromboembolism (VTE)
Active substance: adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S), DHPC type: Safety signal, Last updated: 13/10/2021COVID-19 Vaccine Janssen: Risk for immune … venous thromboembolism (VTE) COVID-19 virus infection … COVID-19 Vaccine Janssen: Risk for immune … -
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Direct healthcare professional communication (DHPC): COVID-19 Vaccine Janssen: Contraindication in individuals with previous capillary leak syndrome and update on thrombosis with thrombocytopenia syndrome
Active substance: adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S), DHPC type: Safety signal, Last updated: 19/07/2021COVID-19 Vaccine Janssen: Contraindication … thrombocytopenia syndrome COVID-19 virus infection … COVID-19 Vaccine Janssen: Contraindication … -
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Opinion/decision on a Paediatric investigation plan (PIP): COVID-19 Vaccine (inactivated, adjuvanted) Valneva, SARS-CoV-2 virus, beta-propiolactone inactivated adjuvanted with CpG 1018 (VLA2001)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Vaccines
PIP number: EMEA-003077-PIP01-21, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 13/05/2022, Last updated: 14/07/2022, Compliance check: XEMEA-003077-PIP01-21 Vaccines … Invented name COVID-19 Vaccine (inactivated, adjuvanted … VLA2001) Therapeutic area Vaccines Decision number P/0184/2022 … -
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Human medicine European public assessment report (EPAR): Nuvaxovid (updated)
SARS-CoV-2 recombinant spike protein, COVID-19 virus infection
Date of authorisation: 20/12/2021,, 
, Revision: 7, Authorised, Last updated: 10/01/2023
Diseases Respiratory Tract Diseases COVID-19 virus infection … Authorised COVID-19 Vaccine (recombinant, adjuvanted … adjuvanted) Overview Nuvaxovid is a vaccine for preventing coronavirus … -
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Human medicine European public assessment report (EPAR): VidPrevtyn Beta
SARS-CoV-2 prefusion Spike delta TM protein, recombinant (B.1.351 strain), COVID-19 virus infection
Date of authorisation: 10/11/2022,, Authorised, Last updated: 30/11/2022
Viral Respiratory Tract Diseases COVID-19 virus infection … Authorised COVID-19 Vaccine (recombinant, adjuvanted … Overview VidPrevtyn Beta is a vaccine for preventing coronavirus … -
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Human medicine European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna) (updated)
CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2), COVID-19 virus infection
Date of authorisation: 06/01/2021,, , Revision: 35, Authorised, Last updated: 03/02/2023
Spikevax (previously COVID-19 Vaccine Moderna) Infections Respiratory … Diseases Lung Diseases Pneumonia COVID-19 virus infection … and elasomeranCOVID-19 mRNA vaccine (nucleoside-modified) Overview … -
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Direct healthcare professional communication (DHPC): COVID-19 mRNA Vaccines Comirnaty and Spikevax: risk of myocarditis and pericarditis
Active substance: Single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2, CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2), DHPC type: Safety signal, Last updated: 19/07/2021COVID-19 mRNA Vaccines Comirnaty and Spikevax: risk … myocarditis and pericarditis COVID-19 virus infection … COVID-19 mRNA Vaccines Comirnaty and Spikevax: risk … -
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Withdrawal from the rolling review process: Bamlanivimab and etesevimab for COVID-19
date of withdrawal: 02/11/2021, Initial authorisation, Last updated: 02/11/2021lanivimab and etesevimab for COVID-19: Withdrawn application … bamlanivimab and etesevimab for COVID-19 EMA has ended the rolling … SARS-CoV-2, the virus causing COVID-19, at two different sites. When … -
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Human medicine European public assessment report (EPAR): Comirnaty (updated)
Single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2, COVID-19 virus infection
Date of authorisation: 21/12/2020,, , Revision: 38, Authorised, Last updated: 03/02/2023
Diseases Lung Diseases Pneumonia COVID-19 virus infection … tozinameranCOVID-19 mRNA Vaccine (nucleoside modified) Overview … modified) Overview Comirnaty is a vaccine for preventing coronavirus … -
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Summary of opinion: Comirnaty
tozinameran, riltozinameran and tozinameran, famtozinameran and tozinameran, COVID-19 mRNA Vaccine (nucleoside modified), opinion date: 19/10/2022, Positive, Last updated: 19/10/2022active immunisation to prevent COVID-19 caused by SARS-CoV-2, in … years. The use of this vaccine should be in accordance with … other compositions of the vaccine are provided in the Summary … -
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Opinion/decision on a Paediatric investigation plan (PIP): Comirnaty, highly purified single-stranded, 5’-capped mRNA encoding full-length SARS-CoV-2 spike protein (BNT162b2)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-002861-PIP02-20-M01, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Concentrate for solution for injection
Decision date: 23/04/2021, Last updated: 19/05/2021, Compliance check: XEMEA-002861-PIP02-20-M01 Vaccines … BNT162b2) Therapeutic area Vaccines Decision number P/0179/2021 … Coronavirus disease 2019 (COVID-19) Route(s) of administration … -
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Veterinary medicine European public assessment report (EPAR): Bovilis Blue-8
bluetongue virus vaccine, serotype 8 (inactivated), Cattle; Sheep
Date of authorisation: 21/11/2017, Revision: 4, Authorised, Last updated: 20/12/2021bluetongue virus vaccine (inactivated) serotype 8 … Blue-8 bluetongue virus vaccine, serotype 8 (inactivated … for? Bovilis Blue-8 is a vaccine used in cattle and sheep … -
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Veterinary medicine European public assessment report (EPAR): Coxevac
inactivated Coxiella burnetii vaccine, strain Nine Mile, Goats; Cattle
Date of authorisation: 30/09/2010, Revision: 7, Authorised, Last updated: 21/07/2020inactivated Coxiella burnetii vaccine … Inactivated Coxiella burnetii vaccine This document is a summary … Coxevac is a veterinary vaccine that contains inactivated …