9017 results
Keyword oral vaccines Remove keyword
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Opinion/decision on a Paediatric investigation plan (PIP): Vaxchora, Cholera vaccine, live attenuated, oral (strain CVD 103-HgR)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-001490-PIP01-13-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Powder for oral suspension, Age-appropriate oral liquid dosage form
Decision date: 22/12/2020, Last updated: 22/09/2021, Compliance check: XEMEA-001490-PIP01-13-M02 Vaccines … Active substance Cholera vaccine, live attenuated oral (strain CVD 103-HgR) Therapeutic … 103-HgR) Therapeutic area Vaccines Decision number P/0509/2020 … -
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Human medicine European public assessment report (EPAR): Vaxchora
vibrio cholerae, strain cvd 103-hgr, live, Cholera
Date of authorisation: 01/04/2020,
, Revision: 6, Authorised, Last updated: 27/09/2022
Authorised cholera vaccine, oral, live Overview Vaxchora is a vaccine to prevent cholera disease … causes severe diarrhoea. The vaccine contains a weakened form … EMEA/H/C/003876 Vaxchora (live oral cholera vaccine) An overview of Vaxchora … -
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Veterinary medicine European public assessment report (EPAR): Rabitec
attenuated live rabies vaccine virus, strain SPBN GASGAS, Red foxes (Vulpes vulpes); Raccoon dogs (Nyctereutes procyonoides)
Date of authorisation: 01/12/2017, Revision: 3, Authorised, Last updated: 07/01/2021Rabies vaccine (live oral) for foxes and raccoon dogs … EU/2/17/219/001 Rabitec --1 Oral suspension Foxes and raccoon … Foxes and raccoon dogs Oral use Suspension: blister … -
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Summary of opinion: Rabitec
Rabies vaccine (live, oral) for foxes and raccoon dogs, opinion date: 23/01/2020, Positive, Last updated: 24/01/2020Rabitec Rabitec Rabies vaccine (live oral) for foxes and raccoon dogs attenuated … dogs attenuated live rabies vaccine virus, strain SPBN GASGAS … -
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Human medicine European public assessment report (EPAR): Dukoral
recombinant cholera toxin B subunit, vibrio cholerae 01, Cholera; Immunization
Date of authorisation: 28/04/2004, Revision: 14, Authorised, Last updated: 06/04/2022Authorised cholera vaccine (inactivated oral) Overview Dukoral is a vaccine that is given by mouth to … EMEA/H/C/000476 Dukoral (cholera vaccine, inactivated oral) An overview of Dukoral and … used for? Dukoral is a vaccine that is given by mouth to … -
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Opinion/decision on a Paediatric investigation plan (PIP): Autologous oral mucosal epithelial cells
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Ophthalmology
PIP number: EMEA-001004-PIP01-10, Route(s) of administration: Ocular use, Pharmaceutical form(s): Living tissue equivalent
Decision date: 23/05/2011, Last updated: 09/06/2011, Compliance check: XKey facts Autologous oral mucosal epithelial cells … of a waiver for autologous oral mucosal epithelial cells … of a waiver for autologous oral mucosal epithelial cells … -
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Referral: Zanil and associated names, and generic products thereof
oxyclozanide, associated names: Zanil Suspension, Zanil Fluke Drench, Zanil Fluke Drench 34 mg/ml Oral Suspension, Article 35
Status: European Commission final decision, opinion/position date: 13/07/2017, EC decision date: 28/09/2017, Last updated: 25/10/2017generic products thereof, are oral suspensions containing 34 … generic products thereof, are oral suspensions containing 34 … Ireland Chanil 34 mg/ml Oral Suspension for Cattle Oxyclozanide … -
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Veterinary medicine European public assessment report (EPAR): Locatim (previously Serinucoli)
Bovine concentrated lactoserum containing specific immunoglobulins G against E. coli F5 (K99) adhesin, Calves, neonatal less than 12 hrs of age
Date of authorisation: 29/03/1999, Revision: 15, Authorised, Last updated: 20/10/2021Authorised Locatim, oral solution for neonatal calves … prescription. Locatim is an oral solution produced from colostrum … Packaging and package size: Oral solution >2.8log10 /ml … -
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Viral safety of oral poliovirus vaccine (OPV) - Scientific guideline
Last updated: 28/05/1998Viral safety of oral poliovirus vaccine (OPV) - Scientific guideline … Viral safety of oral poliovirus vaccine (OPV) - Scientific guideline … PAPER ON VIRAL SAFETY OF ORAL POLIOVIRUS VACCINE (OPV) 1. Viral risk from …
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Human medicine European public assessment report (EPAR): Rotarix
human rotavirus, live attenuated, Immunization; Rotavirus Infections
Date of authorisation: 21/02/2006, Revision: 40, Authorised, Last updated: 29/06/2022Authorised rotavirus vaccine, live Overview This is a summary … is Rotarix? Rotarix is a vaccine that is given by mouth. It … that are made up into an oral suspension in an … -
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Press release: European Medicines Agency sees no safety concerns with the Rotarix oral vaccine
Last updated: 26/03/2010concerns with the Rotarix oral vaccine … strain in batches of the oral vaccine Rotarix does not present … recommendations from its Vaccines Working Party and agreed … -
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Press release: European Medicines Agency statement on new information on Rotarix oral vaccine
Last updated: 19/03/2010new information on Rotarix oral vaccine … strain in batches of the oral vaccine. Through its own tests, the … signals reported with the vaccine that suggest otherwise. It … -
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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 … -
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Human medicine European public assessment report (EPAR): Imvanex
modified vaccinia Ankara - Bavarian Nordic (MVA-BN) virus, Smallpox Vaccine; Monkeypox virus
Date of authorisation: 31/07/2013,, 
, Revision: 25, Authorised, Last updated: 29/03/2023
Mixtures Biological Products Vaccines Viral Vaccines Monkeypox Smallpox Vaccine Monkeypox virus … rised smallpox and monkeypox vaccine (Live Modified Vaccinia Virus Ankara) Overview Imvanex … Ankara) Overview Imvanex is a vaccine used to protect against smallpox … -
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Summary of opinion: Coxevac
inactivated Coxiella burnetii vaccine, opinion date: 15/02/2023, Positive, Last updated: 17/02/2023inactivated Coxiella burnetii vaccine Opinion On 15 February 2023 … inactivated Coxiella burnetii vaccine Species Goats Cattle Active … inactivated Coxiella burnetii vaccine, strain Nine Mile Date opinion … -
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Veterinary medicine European public assessment report (EPAR): Bovilis BTV8
bluetongue virus vaccine, serotype 8 (inactivated), Sheep; Cattle
Date of authorisation: 06/09/2010, Revision: 4, Withdrawn, Last updated: 27/07/2022BTV8 Inactivated adjuvanted vaccine against bluetongue virus … BTV8? Bovilis BTV8 is a vaccine that contains an inactivated … Bovilis BTV8 is serotype 8. The vaccine is used to prevent viraemia … -
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Human medicine European public assessment report (EPAR): RotaTeq
rotavirus serotype G1, serotype G2, serotype G3, serotype G4, serotype P1, Immunization; Rotavirus Infections
Date of authorisation: 26/06/2006, Revision: 36, Authorised, Last updated: 14/04/2023Authorised rotavirus vaccine, live Overview This is a summary … is RotaTeq? RotaTeq is a vaccine that is taken by mouth. It … official recommendations. The vaccine can only be obtained with … -
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Herbal medicinal product: Vaccinii macrocarpi fructus
Vaccinium macrocarpon Aiton, Cranberry, F: Assessment finalised, Last updated: 21/02/2023Vaccinii macrocarpi fructus Urinary … this information. Key facts Vaccinii macrocarpi fructusCranberryVaccinium … Union herbal monograph on Vaccinium macrocarpon Aiton, fructus … -
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Human medicine European public assessment report (EPAR): Celvapan
Whole virion influenza vaccine, inactivated containing antigen of strain A/California/07/2009 (H1N1)v, Disease Outbreaks; Influenza, Human; Immunization
Date of authorisation: 04/03/2009, Revision: 11, Withdrawn, Last updated: 21/12/2016Withdrawn influenza vaccine (H1N1)v (whole virion, Vero … gt;CelvapanEMEA/H/C/000982Whole virion influenza vaccine, inactivated containing antigen … A/California/07/2009 (H1N1)vinfluenza vaccine (H1N1)v (whole virion, Vero … -
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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: 28, Authorised, Last updated: 12/05/2023
xzevria (previously COVID-19 Vaccine AstraZeneca) Myelitis Respiratory … ised patient safety COVID-19 Vaccine (ChAdOx1-S [recombinant … recombinant]) Overview Vaxzevria is a vaccine for preventing coronavirus … -
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Referral: Preflucel
influenza vaccine, purified antigen, Article 36 referrals (prior to July 2012)
Status: European Commission final decision, opinion/position date: 19/07/2012, EC decision date: 10/12/2012, Last updated: 20/07/2012of the seasonal influenza vaccine Preflucel, following an increase … Preflucel? Preflucel is a vaccine used to prevent seasonal … a study to show that the vaccine produced by the revised process … -
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Referral: Engerix B
hepatitis B recombinant vaccine, adsorbed, Article 30 referrals
Status: European Commission final decision, opinion/position date: 13/04/2000, EC decision date: 28/08/2000, Last updated: 28/08/2000SmithKline Beecham, for Engerix B vaccine in all 15 EU Member States … Name: recombinant hepatitis B vaccine: Background information an … Bhepatitis B recombinant vaccine, adsorbedAbout this procedureCPMP/1493/01 … -
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Human medicine European public assessment report (EPAR): Vaxneuvance
pneumococcal polysaccharide conjugate vaccine (adsorbed), Pneumococcal Infections
Date of authorisation: 13/12/2021,, Revision: 4, Authorised, Last updated: 12/05/2023
polysaccharide conjugate vaccine (adsorbed) Overview Vaxneuvance … Overview Vaxneuvance is a vaccine used to protect against three … polysaccharide conjugate vaccine, 15-valent, adsorbed) An … -
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Veterinary medicine European public assessment report (EPAR): Suvaxyn Circo
porcine circovirus vaccine (inactivated, recombinant), Pigs (for fattening)
Date of authorisation: 07/02/2018, Revision: 2, Authorised, Last updated: 30/10/2020porcine circovirus vaccine (inactivated, recombinant … Circo porcine circovirus vaccine (inactivated) This is a … Suvaxyn Circo is a veterinary vaccine used to protect pigs over …