18533 results
Keyword Nutrineal Pd4 Remove keyword
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Veterinary medicine European public assessment report (EPAR): Aftovaxpur DOE
Maximum three of the following purified, inactivated foot-and-mouth disease virus strains: O1 Manisa ≥ 6 PD50*; O1 BFS ≥ 6 PD50*; O Taiwan 3/97 ≥ 6 PD50*; A22 Iraq ≥ 6 PD50*; A24 Cruzeiro ≥ 6 PD50*; A Turkey 14/98 ≥ 6 PD50*; Asia 1 Shamir ≥ 6 PD50*; SAT2 Saudi Arabia ≥ 6 PD50*; * PD50 – 50% protective dose in cattle as described in Ph. Eur. monograph 0063., Pigs; Cattle; Sheep
Date of authorisation: 15/07/2013,
Date of refusal: 16/05/2013, Revision: 8, Authorised, Last updated: 27/03/2020Summary for the public (PDF/83.09 KB … strains: O1 Manisa ≥ 6 PD50* O1 BFS ≥ 6 PD50* O Taiwan 3/97 ≥ 6 PD50* A22 Iraq ≥ 6 … strains: O1 Manisa ≥ 6 PD50*; O1 BFS ≥ 6 PD50*; O Taiwan 3/97 ≥ 6 PD50*; A22 Iraq ≥ 6 PD50*; A24 Cruzeiro ≥ 6 … -
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Orphan designation: adenovirus associated viral vector serotype 5 containing the human pde6β gene for: Treatment of retinitis pigmentosa
Date of designation: 19/06/2013, Positive, Last updated: 09/08/2022serotype 5 containing the human pde6β gene Overview On 19 June … serotype 5 containing the human pde6β gene for the treatment of … mutations (fault) in the pde6β gene which is responsible … -
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Orphan designation: Adeno-associated virus serotype 2/8 vector containing the human PDE6A gene for: Treatment of retinitis pigmentosa
Date of designation: 21/08/2020, Positive, Last updated: 25/11/2020vector containing the human PDE6A gene Overview On 21 August … vector containing the human PDE6A gene … -
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Opinion/decision on a Paediatric investigation plan (PIP): Humanised recombinant IgG4, Anti-PD-1 monoclonal antibody (CS1003)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002939-PIP01-20, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection, Solution for infusion
Decision date: 16/04/2021, Last updated: 17/01/2022, Compliance check: XHumanised recombinant IgG4, Anti-PD-1 monoclonal antibody (CS1003 … humanised recombinant IgG4, anti-PD-1 monoclonal antibody (CS1003 … CS1003), (EMEA-002939-PIP01-20) PDF icon application … -
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Veterinary medicine European public assessment report (EPAR): Respiporc FLUpan H1N1
Influenza A virus/human strain: A/Jena/VI5258/2009 (H1N1)pdm09, inactivated, Pigs
Date of authorisation: 17/05/2017, Revision: 6, Authorised, Last updated: 21/03/2022Summary for the public PDF icon application pdf v-3993-medicine_overview_en.pdf … v-3993-medicine_overview_en.pdf PDF icon application pdf v-3993-medicine_overview_et.pdf … A/Jena/VI5258/2009(H1N1)pdm09 (ATCvet code QI09AA03 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human monoclonal IgG1 antibody directed against Programmed Death Ligand-1 (anti-PD-L1) (MSB0010718C)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-001849-PIP01-15, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 21/12/2015, Last updated: 02/02/2016, Compliance check: XProgrammed Death Ligand-1 (anti-PD-L1) (MSB0010718C) OncologyP/0319/2015EMEA-001849-PIP01-15 … Programmed Death Ligand-1 (anti-PD-L1) (MSB0010718C) (EMEA-001849 … MSB0010718C) (EMEA-001849... PDF icon application … -
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Opinion/decision on a Paediatric investigation plan (PIP): Keytruda, Anti-PD1 humanized monoclonal antibody of the IgG4/kappa class (MK-3475) (pembrolizumab)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001474-PIP01-13-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion, Concentrate for solution for infusion
Decision date: 16/02/2018, Last updated: 21/09/2021, Compliance check: V, 01/02/2019Keytruda Active substance Anti-PD1 humanized monoclonal antibody … www.ema.europa.eu/contact EMA/PDCO/736541/2017 London, 26 … Paediatric Investigation Plan EMA/PDCO/736541/2017 Page 2/10 Basis … -
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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
Summary for the public PDF icon application pdf WC500103712_en pdf PDF icon application … A/California/7/2009 (H1N1)pdm09-like strain; A/Victoria/361/2011 … strains:A/California/7/2009 (H1N1)pdm09 like strain, A/Victoria/361/2011 … -
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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: 09/02/2023Summary for the public (PDF/77.06 KB … nasal) A/Victoria/2570/2019 (H1N1)pdm09 - like strain (A/Victoria/1/2020 … -
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Human medicine European public assessment report (EPAR): Fluad Tetra
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: 5, Authorised, Last updated: 16/01/2023
EPAR - Medicine overview PDF icon application pdf fluad_tetra_medicine_overview_en.pdf … fluad_tetra_medicine_overview_en.pdf PDF icon application pdf fluad_tetra_medicine_overview_lt.pdf … A/Victoria/2570/2019 (H1N1)pdm09 - like strain (A/Victoria/2570/2019 … -
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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: 04/09/2018Summary for the public PDF icon application pdf WC500033848_en pdf PDF icon application … strains:A/California/7/2009 (H1N1)pdm09 - like strain (A/California/7/2009 … -
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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: 29/03/2018Summary for the public PDF icon application pdf WC500031438_en pdf PDF icon application … strains:A/California/7/2009 (H1N1)pdm09 - like strain (A/California/7/2009 … -
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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: 27/06/2017Summary for the public PDF icon application pdf WC500046952_en pdf PDF icon application … A/California/7/2009 (H1N1)pdm09-like strain; A/Switzerland/9715293/2013 … strains:A/California/7/2009 (H1N1)pdm09 - like strain(A/Brisbane/10/2010 … -
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Orphan designation: RNA, [P-deoxy-P-(dimethylamino)] (2',3'-dideoxy-2',3'-imino-2',3'-seco) (2'a→5') (C-m5U-m5U-A-C-A-G-G-C-m5U-C-C-A-A-m5U-A-G-m5U-G-G-m5U-C-A-G-m5U), 5' [P-[4-[[2-[2-(2-hydroxyethoxy)ethoxy]ethoxy]carbonyl]-1-piperazinyl]-N,N-dimethylaminophosphonamidate], 3'-[2'a-[N2-acetyl-L-arginyl-6-aminohexanoyl-L-arginyl-L-arginyl-β-alanyl-L-arginyl-L-arginyl-6-aminohexanoyl-L-arginyl-L-arginyl-β-alanyl-L-arginyl-6-aminohexanoyl-β-alanyl], octahydrochloride for: Treatment of Duchenne muscular dystrophy
Date of designation: 02/02/2010, Withdrawn, Last updated: 03/02/2021RNA, [P-deoxy-P-(dimethylamino)] (2',3'-dideoxy-2',3'-imino-2',3'-seco … orphan designation RNA, [P-deoxy-P-(dimethylamino)] (2',3'-dideoxy-2',3'-imino-2',3'-seco … United Kingdom, for RNA, [P-deoxy-P-(dimethylamino)] (2',3'- dideoxy-2',3'-imino-2',3'-seco … -
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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: 12, Authorised, Last updated: 21/03/2023
EPAR - Medicine overview (PDF/126.78 KB … A/Wisconsin/588/2019 (H1N1)pdm09-like strain (A/Delaware/55/2019 … cultures) A/Wisconsin/588/2019 (H1N1)pdm09-like strain (A/Delaware/55/2019 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Fluenz, Influenza Virus Type A, H3N2Influenza Virus Type A, H1N1Influenza Virus Type B
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-000249-PIP01-10, Route(s) of administration: Intranasal use, Pharmaceutical form(s): Nasal spray suspension
Decision date: 03/01/2011, Last updated: 07/02/2011, Compliance check: XFluenz) (EMEA-000249-PIP01-10) PDF icon application pdf WC500101887_en pdf Adopted 07/02/2011 07/02/2011 … European Union EMA/PDCO/717950/2010 Opinion … product specific waiver EMA/PDCO/717950/2010 Page 5/10 … -
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PDA/EMA 2011 Conference
London, UK, from 03/05/2011 to 05/05/2011, Last updated: 17/03/2011PDA/EMA 2011 Conference … Parenteral Drug Association (PDA) and the European Medicines … Agency are organising the 2011 PDA/EMA Conference in London, the … -
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News: Registration open for PDA/EMA 2011 Conference: 3-5 May 2011
Last updated: 17/03/2011Registration open for PDA/EMA 2011 Conference: 3-5 May 2011 … Registration is open for the PDA/EMA 2011 Conference , being held … Parenteral Drug Association (PDA) and the European Medicines … -
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PDCO: meeting archive 2015-2017
Last updated: 19/04/2022PDCO: meeting archive 2015-2017 … deferrals. Abbreviated as PDCO. More information can be found … under 'Paediatric Committee (PDCO)'. Paediatric Committee …
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PDCO: Agendas, minutes and reports
Last updated: 21/02/2023PDCO: Agendas, minutes and reports … PDCO: Agendas, minutes and reports … 21 February 2023 EMA/PDCO/49245/2023 Human Medicines …
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PDCO: meeting archive 2018-2020
Last updated: 14/06/2022PDCO: meeting archive 2018-2020 … PDCO: meeting archive 2018-2020 … acknowledged. 8 December 2020 EMA/PDCO/622400/2020 Human Medicines …
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PDCO: meeting archive 2012-2014
Last updated: 03/06/2016PDCO: meeting archive 2012-2014 … the Paediatric Committee (PDCO) from 2012 to 2014 … Paediatric Committee (PDCO) - Public Agenda of the 10-12 …
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PDCO: Committee meeting report archive 2007-2011
Last updated: 16/09/2013PDCO: Committee meeting report … Agency's Paediatric Committee (PDCO) for the years 2007 to 2011 … PDCO monthly report of opinions …
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PDCO: Working parties and other groups
Last updated: 31/12/2009PDCO: Working parties and other … PDCO: Working parties and other …
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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: XH3N2).....(EMEA-001715-PIP01-14-M04) (PDF/222.82 KB … H1N1) A/Victoria/2570/2019 (H1N1)pdm09 like strain (A/Victoria/2570/2019 …