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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: 02/06/2021thrombocytopenia - Updated information COVID-19 virus infection … thrombocytopenia - Updated information … thrombocytopenia – Updated information Dear Healthcare Professional … -
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Human medicine European public assessment report (EPAR): Paxlovid (updated)
nirmatrelvir, ritonavir, COVID-19 virus infection
Date of authorisation: 28/01/2022,
, Revision: 8, Authorised, Last updated: 25/01/2023
start of symptoms. For more information about using Paxlovid, see … of medicine that contains information on the medicine for end-users … providing officially approved information for healthcare professionals … -
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Human medicine European public assessment report (EPAR): Xevudy (updated)
Sotrovimab, COVID-19 virus infection
Date of authorisation: 17/12/2021,
, Revision: 7, Authorised, Last updated: 12/01/2023
including anaphylaxis. For more information about using Xevudy, see the … of medicine that contains information on the medicine for end-users … of medicine that contains information on the medicine for end-users … -
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Human medicine European public assessment report (EPAR): Ronapreve
casirivimab, imdevimab, COVID-19 virus infection
Date of authorisation: 12/11/2021,, Revision: 2, Authorised, Last updated: 21/12/2022
of medicine that contains information on the medicine for end-users … a medicine. Summaries of product characteristics form the … characteristics form the basis of information for healthcare professionals … -
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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
national authorities. For more information about using VidPrevtyn Beta … of medicine that contains information on the medicine for end-users … VidPrevtyn Beta triggers a higher production of antibodies against the … -
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Human medicine European public assessment report (EPAR): Regkirona
Regdanvimab, COVID-19 virus infection
Date of authorisation: 12/11/2021,, Revision: 6, Authorised, Last updated: 12/12/2022
including anaphylaxis. For more information about using Regkirona, see … of medicine that contains information on the medicine for end-users … of medicine that contains information on the medicine for end-users … -
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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
providing officially approved information for healthcare professionals … patients on a medicine. The product information includes the summary of product characteristics, package … 2/156 Administrative information Active substance(s) (invented … -
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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
of medicine that contains information on the medicine for end-users … data in the future. More information can be found under 'Conditional … Agency will review any new information that becomes available and … -
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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
national authorities. For more information about using COVID-19 Vaccine … of medicine that contains information on the medicine for end-users … adjuvanted) Valneva triggered the production of higher levels of antibodies … -
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Human medicine European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna)
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: 22/12/2022
providing officially approved information for healthcare professionals … patients on a medicine. The product information includes the summary of product characteristics, package … Page 2/3 Administrative information Active substance(s) (invented … -
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Human medicine European public assessment report (EPAR): Evusheld
tixagevimab, cilgavimab, COVID-19 virus infection
Date of authorisation: 25/03/2022,, Revision: 1, Authorised, Last updated: 16/11/2022
included in the summary of product characteristics and the package … to protect patients. Other information about Evusheld Evusheld received … including anaphylaxis. For more information about using Evusheld, see … -
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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: 37, Authorised, Last updated: 25/01/2023
providing officially approved information for healthcare professionals … patients on a medicine. The product information includes the summary of product characteristics, package … EMEA/H/C/005735/SDA/032.2 Administrative information Confirmation assessment … -
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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,, , Revision: 25, Authorised, Last updated: 30/11/2022
public health bodies. For more information about using Vaxzevria, see … has provided comprehensive information, including data regarding … included in the summary of product characteristics and the package … -
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Human medicine European public assessment report (EPAR): RoActemra
tocilizumab, Arthritis, Rheumatoid; Arthritis, Juvenile Rheumatoid; Cytokine Release Syndrome; Giant Cell Arteritis; COVID-19 virus infection
Date of authorisation: 15/01/2009, Revision: 40, Authorised, Last updated: 25/10/2022pack containing important information on the safety and correct … alert card with key safety information for patients. Recommendations … included in the summary of product characteristics and the package … -
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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: 19/10/2022Committee for Medicinal Products for Human Use (CHMP) Summary … the Committee for Medicinal Products for Human Use (CHMP) adopted … authorisation for the medicinal product Comirnaty. The marketing … -
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Withdrawn application: Dexamethasone Taw
dexamethasone phosphate, date of withdrawal: 20/01/2021, Initial authorisation, Last updated: 19/03/2021had evaluated the initial information from the company and had … Committee for Medicinal Products for Human Use (CHMP) Withdrawal … adopted by the CHMP with all information of a commercially confidential … -
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Opinion/decision on a Paediatric investigation plan (PIP): RoActemra, tocilizumab
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000309-PIP02-14, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection in pre-filled syringe
Decision date: 15/06/2015, Last updated: 02/09/2015, Compliance check: X2015 on the granting of a product-specific waiver for tocilizumab (RoActemra … summary of the evaluation of a product-specific waiver RoActemra (tocilizumab … summary of the evaluation of a product-specific waiver RoActemra (tocilizumab … -
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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: 23/06/2021DHPC) contains important information for healthcare professionals … Agency and the would like to inform you of the following … The Vaxzevria Summary of Product Characteristics (SmPC) will … -
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Direct healthcare professional communication (DHPC): RoActemra (tocilizumab): Temporary supply shortage for 162 mg solution for subcutaneous injection and RoActemra 20 mg/mL concentrate for solution for infusion (IV) & recommendations to manage potential risk of disease flare in patient
Active substance: tocilizumab, DHPC type: Medicine shortage, Last updated: 02/09/2021DHPC) contains important information for healthcare professionals … Agency and the would like to inform you of the following: Summary … patient to this medicinal product may be appropriate. -If … -
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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: 13/10/2021DHPC) contains important information for healthcare professionals … with the following updated information: Summary • Cases … -
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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: 26/04/2021DHPC) contains important information for healthcare professionals … Agency and the would like to inform you of the following: Summary … recommended an update to the product information to reflect the current knowledge … -
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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: 19/07/2021DHPC) contains important information for healthcare professionals … Agency and would like to inform you of the following: Summary … recommended an update to the product information of the COVID-19 Vaccine Janssen … -
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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: 13/04/2021DHPC) contains important information for healthcare professionals … Agency and the would like to inform you of the following: Summary … and or thrombocytopenia and inform vaccinees accordingly … -
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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: 24/03/2021DHPC) contains important information for healthcare professionals … Agency and the would like to inform you of the following: Summary … special attention to the information on the sex, age, risk factors … -
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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: 13/10/2021DHPC) contains important information for healthcare professionals … Agency and would like to inform you of the following …