7423 results
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Veterinary medicine European public assessment report (EPAR): Strangvac
Recombinant Streptococcus equi protein CCE, Recombinant Streptococcus equi protein Eq85, Recombinant Streptococcus equi protein IdeE, Horses
Date of authorisation: 16/08/2021, Authorised, Last updated: 27/10/2021Authorised Streptococcus equi vaccine (recombinant proteins … Strangvac (Streptococcus equi vaccine, recombinant proteins … the bacterium Streptococcus equi. Strangvac contains Streptococcus … -
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Summary of opinion: Strangvac
Streptococcus equi vaccine (recombinant proteins), opinion date: 17/06/2021, Positive, Last updated: 18/06/2021Common name: Streptococcus equi vaccine (recombinant proteins … recombinant proteins CCE and Eq85, which contain amino acid … respectively five (CCE) and two (Eq85) different cell-surface … -
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Veterinary medicine European public assessment report (EPAR): Equilis Prequenza
equine influenza-virus strains: A/equine-2/South Africa/4/03, A/equine-2/Newmarket/2/93, Horses
Date of authorisation: 08/07/2005, Revision: 9, Authorised, Last updated: 16/12/2020Equilis Prequenza … Authorised vaccine against equine influenza in horses Overview … part of the EPAR). What is Equilis Prequenza Equilis Prequenza is a vaccine for … -
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Veterinary medicine European public assessment report (EPAR): Equilis Prequenza Te
equine influenza-virus strains: A/equine-2/South Africa/4/03, A/equine-2/Newmarket/2/93, tetanus toxoid, Horses
Date of authorisation: 08/07/2005, Revision: 10, Authorised, Last updated: 10/12/2020Equilis Prequenza Te … Authorised vaccine against equine influenza and tetanus in … part of the EPAR). What is Equilis Prequenza Te Equilis Prequenza Te is a vaccine … -
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Veterinary medicine European public assessment report (EPAR): Equilis StrepE
live deletion-mutant Streptococcus equi strain TW928, Horses
Date of authorisation: 07/05/2004, Revision: 10, Authorised, Last updated: 15/02/2021Equilis StrepE … vaccine against Streptococcus equi Overview Equilis StrepE is a veterinary vaccine … EMA/378878/2007 EMEA/V/C/000078 Equilis StrepE (live deletion mutant … -
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Withdrawn application: Equitend
date of withdrawal: 05/11/2018, Initial authorisation, Last updated: 01/04/2019Equitend: Withdrawn application … Equitend Equitend … -
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Herbal medicinal product: Equiseti herba
Equisetum arvense L., Horsetail herb, F: Assessment finalised, Last updated: 28/04/2016Equiseti herba Urinary tract and … aerial parts of the plant Equisetum arvense L. The Committee … public Horsetail herb Equisetum arvense L., herba This … -
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Summary of opinion: DogStem
equine umbilical cord-derived mesenchymal stem cells, opinion date: 15/06/2022, Positive, Last updated: 17/06/2022equine umbilical cord-derived mesenchymal … action. medicinal product is EquiCord S.L. DogStem is a biological … medicinal product containing equine umbilical cord-derived mesenchymal … -
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Veterinary medicine European public assessment report (EPAR): Horse Allo 20
allogeneic equine adipose-derived mesenchymal stem cells, Horses
Date of refusal: 13/05/2019, Refused, Last updated: 12/09/2019Refused allogeneic equine adipose-derived mesenchymal … that contains allogeneic equine mesenchymal stem cells as … Horse Allo 20 Allogeneic equine adipose-derived mesenchymal … -
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Direct healthcare professional communication (DHPC): Arti-Cell® Forte and RenuTend® market recall of select product batches
Active substance: Equine allogeneic mesenchymal stem cells, DHPC type: Quality defect, Last updated: 04/05/2023Arti-Cell Forte Active substance Equine allogeneic mesenchymal stem … levels of DNA associated with equine parvovirus EqPV-H). The horse has shown no … adverse events associated with EqPV-H in horses treated with these … -
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Veterinary medicine European public assessment report (EPAR): Equioxx
firocoxib, Horses
Date of authorisation: 25/06/2008, Revision: 12, Authorised, Last updated: 26/01/2022Equioxx … assessment report (EPAR) for Equioxx.It explains how the Agency assessed … practical advice on how to use Equioxx. For practical information … -
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Veterinary medicine European public assessment report (EPAR): Equisolon
Prednisolone, Horses
Date of authorisation: 12/03/2014, Revision: 9, Authorised, Last updated: 17/09/2021Equisolon … part of the EPAR). What is Equisolon? Equisolon is a veterinary medicine … be given by mouth. What is Equisolon used for Equisolon is used to treat recurrent … -
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Veterinary medicine European public assessment report (EPAR): Aservo EquiHaler
ciclesonide, Horses
Date of authorisation: 28/01/2020, Authorised, Last updated: 28/02/2020Aservo EquiHaler … Aservo EquiHaler … Aservo EquiHaler ciclesonide ciclesonide … -
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Human medicine European public assessment report (EPAR): Equidacent
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell
Date of authorisation: 24/09/2020,
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, Revision: 3, Withdrawn, Last updated: 25/11/2021
Equidacent Cancer Neoplasms Rectal … Equidacent … EMEA/H/C/005181 Public statement Equidacent Withdrawal of the marketing … -
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Veterinary medicine European public assessment report (EPAR): Arti-Cell Forte
chondrogenic induced equine allogeneic peripheral blood-derived mesenchymal stem cells, Horses
Date of authorisation: 29/03/2019, Revision: 5, Authorised, Last updated: 25/10/2021horised chondrogenic induced equine allogeneic peripheral blood-derived … cells which are obtained from equine blood. Stem cells can develop … and a second vial contains equine allogeneic plasma (EAP) which … -
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Summary of opinion: RenuTend
tenogenic primed equine allogeneic peripheral blood-derived mesenchymal stem cells, opinion date: 16/02/2022, Positive, Last updated: 21/02/2022tenogenic primed equine allogeneic peripheral blood-derived … RenuTend Tenogenic primed equine allogeneic peripheral blood-derived … containing tenogenic primed equine allogeneic peripheral blood-derived … -
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Opinion/decision on a Paediatric investigation plan (PIP): Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain, Split influenza virus, inactivated containing antigens equivalent to the A/H3N2-like strain, Split influenza virus, inactivated containing antigens equivalent to the B-like strain (Victoria lineage), Split influenza virus, inactivated containing antigens equivalent to the B-like strain (Yamagata lineage)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-002359-PIP01-18-M05, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 10/06/2022, Last updated: 29/06/2023, Compliance check: Xinactivated containing antigens equivalent to the A/H1N1-like strain … inactivated containing antigens equivalent to the A/H3N2-like strain … inactivated containing antigens equivalent to the B-like strain (Victoria … -
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Opinion/decision on a Paediatric investigation plan (PIP): Split influenza virus, inactivated containing antigens equivalent to the B-like strain (B/Yamagata lineage), Split influenza virus, inactivated containing antigens equivalent to the B-like strain (B/Victoria lineage), Split influenza virus, inactivated (B/Victoria lineage), Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain, Split influenza virus, inactivated containing antigens equivalent to the A/H3N2-like strain
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-001254-PIP01-11-M02, Route(s) of administration: Subcutaneous use, Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 08/05/2017, Last updated: 02/03/2018, Compliance check: V, 23/06/2017inactivated containing antigens equivalent to the B-like strain (B/Yamagata … inactivated containing antigens equivalent to the B-like strain (B/Victoria … inactivated containing antigens equivalent to the A/H1N1-like strain … -
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Veterinary medicine European public assessment report (EPAR): Equilis Te
tetanus toxoid, Horses
Date of authorisation: 08/07/2005, Revision: 8, Authorised, Last updated: 15/02/2021Equilis Te … against tetanus Overview Equilis Te is a veterinary vaccine … substance tetanus toxoid. How is Equilis Te used? The medicine can … -
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Orphan designation: Anti-H5N1 equine immunoglobulin F(ab')2 fragments for: Treatment of avian influenza
Date of designation: 28/07/2015, Positive, Last updated: 18/08/2015Anti-H5N1 equine immunoglobulin F(ab')2 fragme … orphan designation Anti-H5N1 equine immunoglobulin F(ab')2 fragments … orphan designation Anti-H5N1 equine immunoglobulin F(ab')2 fragments … -
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Orphan designation: Equine immunoglobulin F(ab')2 fragments targeting Shiga toxin for: Prevention of haemolytic uraemic syndrome
Date of designation: 25/05/2018, Positive, Last updated: 24/07/2018Equine immunoglobulin F(ab')2 fragments … opinion on orphan designation Equine immunoglobulin F(ab’)2 … opinion on orphan designation Equine immunoglobulin F(ab’)2 … -
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Veterinary medicine European public assessment report (EPAR): Equilis West Nile
inactivated chimaeric flavivirus strain YF-WN, Horses
Date of authorisation: 06/06/2013, Revision: 2, Authorised, Last updated: 15/10/2018Equilis West Nile … part of the EPAR). What is Equilis West Nile Equilis West Nile is a veterinary … suspension for injection. What is Equilis West Nile used for Equilis West Nile … -
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Opinion/decision on a Paediatric investigation plan (PIP): Equine immunoglobulin F(ab')2 fragments targeting Shiga toxin
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-002444-PIP02-18, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 10/09/2020, Last updated: 23/03/2020, Compliance check: XKey facts Equine immunoglobulin F(ab')2 fragments … granting of a deferral for equine Immunoglobulin F(ab')2 fragments … Equine immunoglobulin F(ab')2 fragments … -
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Veterinary medicine European public assessment report (EPAR): Equip WNV (previously Duvaxyn WNV)
inactivated West Nile virus, strain VM-2, Horses
Date of authorisation: 21/11/2008, Revision: 13, Authorised, Last updated: 10/04/2017Equip WNV (previously Duvaxyn WNV … Equip WNV (previously Duvaxyn WNV … summary for the public Equip WNV West Nile virus strain … -
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Veterinary medicine European public assessment report (EPAR): ProteqFlu
Vcp 2242 virus / Vcp1529 virus / Vcp1533 virus / vCP3011 virus, Horses
Date of authorisation: 06/03/2003, Revision: 14, Authorised, Last updated: 23/11/2020Equine influenza vaccine (live recom … for the public ProteqFlu Equine influenza vaccine This … It contains parts of two equine influenza (flu) strains …