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Human medicine European public assessment report (EPAR): Fluad Tetra (updated)
A/Victoria/2570/2019 (H1N1)pdm09 like strain (A/Victoria/2570/2019 IVR‐215) A/Darwin/9/2021 (H3N2) like strain (A/Darwin/6/2021 IVR-227) B/Austria/1359417/2021 like strain (B/Austria/1359417/2021 BVR-26) B/Phuket/3073/2013 like strain (B/Phuket/3073/2013 BVR‐1B), Influenza, Human
Date of authorisation: 20/05/2020,
, Revision: 6, Authorised, Last updated: 22/05/2023
valid throughout the EU on 20 May 2020. List item … dose A/Victoria/2570/2019 (H1N1)pdm09 - like strain … strain (A/Victoria/2570/2019 IVR‐215) 15 micrograms … -
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Human medicine European public assessment report (EPAR): Fluenz Tetra
A/Victoria/2570/2019 (H1N1)pdm09 - like strain (A/Victoria/1/2020, MEDI 340505) A/Darwin/9/2021 (H3N2) - like strain (A/Norway/16606/2021, MEDI 355293) B/Austria/1359417/2021 - like strain (B/Austria/1359417/2021, MEDI 355292) B/Phuket/3073/2013 - like strain (B/Phuket/3073/2013, MEDI 306444, Influenza, Human
Date of authorisation: 04/12/2013, Revision: 23, Authorised, Last updated: 09/02/2023main study involved over 2,000 children aged 2 to 17 years … Fluenz Tetra on 4 December 2013. For more information about … Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0 20 3660 5555 Send a question … -
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Opinion/decision on a Paediatric investigation plan (PIP): DNA, d(P-thio)([2'-0-(2-methoxyethyl)]m5rU-[2'-0-(2-methoxyethyl)]m5rC-[2'-0-(2-methoxyethyl)]m5rU-[2'-0-(2-methoxyethyl)]m5rU-[2'-0-(2-methoxyethyl)]rG-G-T-T-A-m5C-A-T-G-A-A-[2'-0-(2-methoxyethyl)]rA-[2'-0-(2-methoxyethyl)]m5rU-[2'-0-(2-methoxyethyl)]m5rC-[2'-0-(2-methoxyethy l)]m5rC-[2'-0-(2-methoxyethyl)]m5rC), sodium salt
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Neurology
PIP number: EMEA-001773-PIP01-15, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 07/08/2015, Last updated: 17/12/2015, Compliance check: Xsubstance DNA, d(P-thio)([2'-0-(2-methoxyethyl)]m5rU 2'-0-(2-methoxyethyl)]m5rC 2'-0-(2-methoxyethyl)]m5rU … Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0 20 3660 5510 Send a question … www.ema.europa.eu/contact 14 December 2015 EMA/739394 2015 Human Medicines Research … -
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Veterinary medicine European public assessment report (EPAR): Zulvac 1+8 Ovis
inactivated bluetongue virus, serotype 1, strain BTV-1/ALG2006/01, inactivated bluetongue virus, serotype 8, strain btv-8/bel2006/02, Sheep
Date of authorisation: 14/03/2011, Revision: 6, Authorised, Last updated: 23/10/2019efficacy of the vaccine. In 2013 the CVMP considered that … Zulvac 1+8 Ovis on 14 March 2011. Information on the prescription … Union Telephone +44 (0)20 7418 8400 Facsimile +44 (0 20 E-mail info@ema.europa.eu … -
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Human medicine European public assessment report (EPAR): Flucelvax Tetra (updated)
A/Wisconsin/588/2019 (H1N1)pdm09-like strain (A/Delaware/55/2019 CVR-45) A/Darwin/6/2021 (H3N2)-like strain (A/Darwin/11/2021, wild type) B/Austria/1359417/2021-like strain (B/Singapore/WUH4618/2021, wild type) B/Phuket/3073/2013-like strain (B/Singapore/INFTT-16-0610/2016, wild type), Influenza, Human
Date of authorisation: 12/12/2018,, Revision: 13, Authorised, Last updated: 23/05/2023
throughout the EU on 12 December 2018. Summary documents Flucelvax … strains*: A/Wisconsin/588/2019 (H1N1)pdm09-like strain (A/De … H1N1)pdm09-like strain (A/Delaware/55/2019 CVR-45) 15 micrograms HA … -
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Orphan designation: Refusal of orphan designation for the treatment of poisoning by local anaesthetics
Date of refusal of designation: 03/04/2017, Negative, Last updated: 15/05/201720% Intravenous fat emulsion … fat emulsion consisting of 20% soybean oil, 1.2% egg yolk … opinion on orphan designation 20% intravenous fat emulsion … -
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Human medicine European public assessment report (EPAR): Intanza
influenza virus (inactivated, split) of the following strains:A/California/7/2009 (H1N1)pdm09 - like strain (A/California/7/2009, NYMC X-179A)A/Hong Kong/4801/2014 (H3N2) - like strain (A/Hong Kong/4801/2014, NYMC X-263B)B/Brisbane/60/2008 - like strain (B/Brisbane/60/2008, wild type), Influenza, Human; Immunization
Date of authorisation: 24/02/2009, Revision: 18, Withdrawn, Last updated: 04/09/2018WC500033848_sv.pdf 07/04/2009 04/09 2018 Generic More detail is available … was last updated on 04/09/2018 Authorisation details Product … like strain (A/California/7/2009, NYMC X-179A)A/Hong Kong/4801 … -
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Human medicine European public assessment report (EPAR): IDflu
influenza virus (inactivated, split) of the following strains:A/California/7/2009 (H1N1)pdm09 - like strain (A/California/7/2009, NYMC X-179A)A/Hong Kong/4801/2014 (H3N2) - like strain (A/Hong Kong/4801/2014, NYMC X-263B)B/Brisbane/60/2008 - like strain (B/Brisbane/60/2008, wild type), Influenza, Human; Immunization
Date of authorisation: 24/02/2009, Revision: 13, Withdrawn, Last updated: 29/03/2018WC500031438_sv.pdf 07/04/2009 20/03/2018 Generic More detail is available … was last updated on 29/03/2018 Authorisation details Product … like strain (A/California/7/2009, NYMC X-179A)A/Hong Kong/4801 … -
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Human medicine European public assessment report (EPAR): Optaflu
influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains:A/California/7/2009 (H1N1)pdm09 - like strain(A/Brisbane/10/2010, wild type)A/Switzerland/9715293/2013 (H3N2) - like strain(A/South Australia/55/2014, wild type)B/Phuket/3073/2013–like strain(B/Utah/9/2014, wild type), Influenza, Human; Immunization
Date of authorisation: 01/06/2007, Revision: 16, Withdrawn, Last updated: 27/06/2017WC500046952_sv.pdf 22/02/2008 02/12 2015 Generic More detail is available … was last updated on 27/06/2017 Authorisation details Product … strain(A/South Australia/55/2014, wild type)B/Phuket/3073/2013–like … -
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Veterinary medicine European public assessment report (EPAR): Oxyglobin
haemoglobin glutamer-200 (bovine), Dogs
Date of authorisation: 29/11/1999, Revision: 16, Authorised, Last updated: 20/10/2020horised Haemoglobin glutamer-200 (bovine) Overview This is … bovine haemoglobin glutamer-200 (at a strength of 130 mg/ml … contains haemoglobin glutamer-200, which is made from haemoglobin … -
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Orphan designation: 20-hydroxyecdysone for: Treatment of Duchenne muscular dystrophy
Date of designation: 27/06/2018, Positive, Last updated: 21/08/2018EU/3/18/2030 … EU/3/18/2030: Orphan designation for the … Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0 20 3660 5555 Send a question … -
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Veterinary medicine European public assessment report (EPAR): Zulvac 1+8 Bovis
inactivated bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 E1 RP, inactivated bluetongue virus, serotype 8, strain btv-8/bel2006/02, Cattle
Date of authorisation: 08/03/2012,
, Revision: 6, Authorised, Last updated: 23/10/2019
efficacy of the vaccine. In 2013 the CVMP considered that … Zulvac 1+8 Bovis on 08/03/2012. Information on the prescription … EMA/39462/2012 EMEA/V/C/002473 EPAR summary … -
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Opinion/decision on a Paediatric investigation plan (PIP): Optaflu, Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains: A/Solomon Islands/3/2006 (H1N1)-like strain (A/Solomon Islands/3/2006, IVR-145); A/Wisconsin/67/2005 (H3N2)-like strain (A/Wisconsin/67/2005, NYMC X161B); B/Malaysia/2506/2004-like strain (B/Malaysia/2506/2004)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000124-PIP01-07-M02, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection in pre-filled syringe
Decision date: 28/09/2012, Last updated: 27/02/2019, Compliance check: Xstrains: A/Solomon Islands/3/2006 (H1N1)-like strain (A/Solomon … strain (A/Solomon Islands/3/2006, IVR-145); A/Wisconsin/67/2005 … H3N2)-like strain (A/Wisconsin/67/2005, NYMC X161B); B/Malaysia/2506/2004-like … -
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Veterinary medicine European public assessment report (EPAR): Zulvac BTV
One of the following inactivated bluetongue virus strains:Inactivated bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 E1Inactivated bluetongue virus, serotype 8, strain BTV-8/BEL2006/02Inactivated bluetongue virus, serotype 4, strain SPA-1/2004, Sheep; Cattle
Date of authorisation: 25/04/2017, Revision: 2, Authorised, Last updated: 01/09/2021throughout the EU on 25 April 2017. The name of the medicine … Zulvac BTV on 21 February 2019. List item … European Medicines Agency, 2021. Reproduction is authorised … -
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Veterinary medicine European public assessment report (EPAR): Eurican Herpes 205
Canine herpesvirus (F205 strain) antigens, Dogs
Date of authorisation: 26/03/2001, Revision: 12, Authorised, Last updated: 16/02/2021Eurican Herpes 205 … Eurican Herpes 205 … European Medicines Agency, 2021. Reproduction is authorised … -
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Veterinary medicine European public assessment report (EPAR): Zulvac 8 Ovis
inactivated bluetongue virus, serotype 8, strain btv-8/bel2006/02, Sheep
Date of authorisation: 15/01/2010, Revision: 9, Authorised, Last updated: 12/02/2021efficacy of the vaccine. In 2013 the CVMP considered that … Zulvac 8 Ovis on 15 January 2010. Information on the prescription … Union Telephone +44 (0)20 7418 8400 Facsimile +44 (0 20 7418 8447 E-mail info@ema.europa.eu … -
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Veterinary medicine European public assessment report (EPAR): Zulvac 8 Bovis
inactivated bluetongue virus, serotype 8, strain btv-8/bel2006/02, Cattle
Date of authorisation: 15/01/2010, Revision: 7, Withdrawn, Last updated: 24/11/2020First published: 19/04/2013 Last updated: 06/05 2014 EMA/CVMP/643080 2009 Click to see translations … serotype 8, strain btv-8/bel2006/02 … -
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Summary of opinion: Zulvac BTV
Bluetongue virus vaccine (inactivated) (multistrain: 1 strain out of a set of 3), opinion date: 20/05/2020, Positive, Last updated: 25/05/2020serotype 1, strain BTV-1/ALG2006/01 E1Inactivated bluetongue … serotype 8, strain BTV-8/BEL2006/02Inactivated bluetongue virus … serotype 4, strain SPA-1/2004 … -
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Human medicine European public assessment report (EPAR): Fluenz
Reassortant influenza virus (live attenuated) of the following strains:A/California/7/2009 (H1N1)pdm09 like strain, A/Victoria/361/2011 (H3N2) like strain, B/Massachusetts/2/2012 like strain, Influenza, Human; Immunization
Date of authorisation: 27/01/2011,, Revision: 4, Withdrawn, Last updated: 03/12/2014
WC500103712_sv.pdf 17/03/2011 03/12 2014 EMA/CHMP/682933 2010 Generic More detail is available … was last updated on 03/12/2014 Authorisation details Product … Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0 20 3660 5520 Send a question … -
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Opinion/decision on a Paediatric investigation plan (PIP): Flucelvax Tetra, Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H1N1), Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H3N2), Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Yamagata lineage), Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Victoria lineage) [QIVc]
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-002068-PIP01-16-M04, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 03/12/2021, Last updated: 29/03/2023, Compliance check: XVaccines Decision number P/0492/2021 PIP number EMEA-002068-PIP01-16-M04 … 6000 EMA/627653/2021 European Medicines Agency … Medicines Agency decision P/0492/2021 of 3 December 2021 on the acceptance of a … -
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Orphan designation: 20-pentaerythritol poly (oxy-1,2-ethanediyl)-carboxymethyl-glycinate-7-ethyl-10-hydroxycamptothecine 10-[1,4'-bipiperidine]-1'-carboxylate for: Treatment of ovarian cancer
Date of designation: 27/09/2011, Positive,20-pentaerythritol poly (oxy-1,2-ethanediyl)-carboxymethyl-glycinate-7-ethyl-10-hydroxycamptothecine … 20-pentaerythritol poly (oxy-1,2-ethanediyl)-carboxymethyl-glycinate-7-ethyl-10-hydroxycamptothecine … Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0 20 7523 7040 E-mail info@ema.europa.eu … -
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Opinion/decision on a Paediatric investigation plan (PIP): CpG 1018/Alum-adjuvanted recombinant SARS-CoV-2 Trimeric Spike (S) protein subunit vaccine (SCB- 2019)
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-002987-PIP01-21, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Solution for injection
Decision date: 11/03/2022, Last updated: 19/04/2023, Compliance check: Xprotein subunit vaccine (SCB- 2019) VaccinesP/0070 2022EMEA-002987-PIP01-21 Solution … Prevention of Coronavirus disease 2019 (COVID-19) Intramuscular … deferral(s) Decision P/0070/2022 : EMA decision of 11 March … -
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Opinion/decision on a Paediatric investigation plan (PIP): Fluad Tetra, Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H3N2), Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Yamagata lineage), Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Victoria lineage), Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H1N1)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-001715-PIP01-14-M04, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 29/01/2020, Last updated: 01/07/2021, Compliance check: XVaccines Decision number P/0355/2020 PIP number EMEA-001715-PIP01-14-M04 … 0)88 781 6000 EMA/430121/2020 European Medicines Agency … Medicines Agency decision P/0355/2020 of 9 September 2020 on the acceptance of a … -
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Opinion/decision on a Paediatric investigation plan (PIP): Recombinant anti-human CD20 and anti-human CD3 monoclonal antibody (RO7082859; CD20 CD3 TCB)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Oncology
PIP number: EMEA-002648-PIP01-19, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 18/03/2020, Last updated: 30/07/2020, Compliance check: XRecombinant anti-human CD20 and anti-human CD3 monoclonal … monoclonal antibody (RO7082859; CD20 CD3 TCB) Therapeutic area … Oncology Decision number P/0094/2020 PIP number EMEA-002648-PIP01-19 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Neisseria meningitidis serogroup B recombinant lipoprotein (rLP2086; subfamily A; Escherichia coli), Neisseria meningitidis serogroup B recombinant lipoprotein (rLP2086; subfamily B; Escherichia coli)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-001037-PIP02-11-M05, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 22/03/2019, Last updated: 24/06/2019, Compliance check: Xrecombinant lipoprotein (rLP2086; subfamily A; Escherichia … recombinant lipoprotein (rLP2086; subfamily B; Escherichia … Escherichia coli) VaccinesP/0098/2019EMEA-001037-PIP02-11-M05 Suspension …