79 results
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Opinion/decision on a Paediatric investigation plan (PIP): Vaxzevria (previously COVID-19 Vaccine AstraZeneca), COVID-19 vaccine (ChAdOx1-S [recombinant]) (AZD1222)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-002862-PIP01-20-M01, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 07/07/2021, Last updated: 18/07/2022, Compliance check: Xname Vaxzevria (previously COVID-19 Vaccine AstraZeneca) Active … AstraZeneca) Active substance COVID-19 vaccine (ChAdOx1-S [recombinant … Coronavirus disease 2019 (COVID-19) Route(s) of administration … -
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Opinion/decision on a Paediatric investigation plan (PIP): COVID-19 vaccine (Ad26.COV2-S (recombinant))
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-002880-PIP01-20, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection in cartridge
Decision date: 05/02/2021, Last updated: 16/02/2021, Compliance check: XKey facts COVID-19 vaccine (Ad26.COV2-S (recombinant … Coronavirus disease 2019 (COVID-19) Intramuscular use Janssen-Cilag … granting of a deferral for COVID-19 vaccine (Ad26.COV2-S (recombinant … -
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Opinion/decision on a Paediatric investigation plan (PIP): COVID-19 Vaccine (inactivated, adjuvanted) Valneva, SARS-CoV-2 virus, beta-propiolactone inactivated adjuvanted with CpG 1018 (VLA2001)
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-003077-PIP01-21, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 13/05/2022, Last updated: 14/07/2022, Compliance check: XInvented name COVID-19 Vaccine (inactivated, adjuvanted … Coronavirus disease 2019 (COVID-19) Route(s) of administration … Coronavirus disease 2019 (COVID-19) Pharmaceutical form(s … -
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Opinion/decision on a Paediatric investigation plan (PIP): Spikevax (previously COVID-19 Vaccine Moderna), mRNA that encodes for the pre-fusion stabilized spike glycoprotein of SARS-CoV-2 (mRNA-1273) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases; Vaccines
PIP number: EMEA-002893- PIP01-20-M01, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Dispersion for injection
Decision date: 22/11/2021, Last updated: 20/02/2023, Compliance check: Xname Spikevax (previously COVID-19 Vaccine Moderna) Spikevax … Coronavirus disease 2019 (COVID-19) Route(s) of administration … coronavirus disease 2019 (COVID-19) Authorised indication(s … -
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Opinion/decision on a Paediatric investigation plan (PIP): Comirnaty, highly purified single-stranded, 5’-capped mRNA encoding full-length SARS-CoV-2 spike protein (BNT162b2)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-002861-PIP02-20-M01, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Concentrate for solution for injection
Decision date: 23/04/2021, Last updated: 19/05/2021, Compliance check: XCoronavirus disease 2019 (COVID-19) Route(s) of administration … Coronavirus disease 2019 (COVID-19) Authorised indication(s … Coronavirus disease 2019 (COVID-19) 2.1.1. Indication(s … -
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News: EMA starts evaluating use of COVID-19 vaccine Comirnaty in children aged 5 to 11
CHMP, Last updated: 18/10/2021EMA starts evaluating use of COVID-19 vaccine Comirnaty in children … EMA starts evaluating use of COVID-19 vaccine Comirnaty in children … -
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News: EMA receives application for marketing authorisation for Ronapreve (casirivimab / imdevimab) for treatment and prevention of COVID-19
CHMP, PDCO, PRAC, Last updated: 11/10/2021treatment and prevention of COVID-19 … treatment and prevention of COVID-19 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Xevudy, Sotrovimab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002899-PIP01-20-M01, Route(s) of administration: Intravenous use, Intramuscular use, Pharmaceutical form(s): Concentrate for solution for infusion, Solution for injection/infusion
Decision date: 12/11/2021, Last updated: 13/02/2023, Compliance check: XCoronavirus disease 2019 (COVID-19) Intravenous use Intramuscular … Generic Xevudy: EPAR Topics: COVID-19 Paediatrics … coronavirus disease 2019 (COVID-19) Pharmaceutical form(s … -
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Opinion/decision on a Paediatric investigation plan (PIP): Zorecimeran
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-002986-PIP01-21, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Concentrate and solvent for dispersion for injection
Decision date: 17/05/2021, Last updated: 11/04/2022, Compliance check: XCoronavirus disease 2019 (COVID-19) Intramuscular use CureVac … 11/04/2022 Generic Topics: COVID-19 Paediatrics … Coronavirus disease 2019 (COVID-19) has been discontinued … -
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Opinion/decision on a Paediatric investigation plan (PIP): Tixagevimab (AZD8895)
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-002900-PIP01-20, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Solution for injection
Decision date: 08/06/2021, Last updated: 17/06/2021, Compliance check: XCoronavirus disease 2019 (COVID-19) Treatment of Coronavirus … Coronavirus disease 2019 (COVID-19) Intramuscular use AstraZeneca … EMA/300113/2021 Generic Topics: COVID-19 Paediatrics … -
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Opinion/decision on a Paediatric investigation plan (PIP): Cilgavimab (AZD1061)
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-002925-PIP01-20, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Solution for injection
Decision date: 08/06/2021, Last updated: 17/06/2021, Compliance check: XCoronavirus disease 2019 (COVID-19) Treatment of Coronavirus … Coronavirus disease 2019 (COVID-19) Intramuscular use AstraZeneca … EMA/300136/2021 Generic Topics: COVID-19 Paediatrics … -
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Opinion/decision on a Paediatric investigation plan (PIP): Imdevimab
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-002965-PIP01-21, Route(s) of administration: Subcutaneous use, Intravenous use, Pharmaceutical form(s): Solution for injection, Concentrate for solution for infusion
Decision date: 16/08/2021, Last updated: 19/08/2021, Compliance check: XCoronavirus disease 2019 (COVID-19) Treatment of Coronavirus … Coronavirus disease 2019 (COVID-19) Subcutaneous use Intravenous … EMA/418668/2021 Generic Topics: COVID-19 Paediatrics … -
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Opinion/decision on a Paediatric investigation plan (PIP): Casirivimab
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-002964-PIP01-21, Route(s) of administration: Subcutaneous use, Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion, Solution for injection
Decision date: 16/08/2021, Last updated: 19/08/2021, Compliance check: XCoronavirus disease 2019 (COVID-19) Treatment of Coronavirus … Coronavirus disease 2019 (COVID-19) Subcutaneous use Intravenous … EMA/418667/2021 Generic Topics: COVID-19 Paediatrics … -
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Opinion/decision on a Paediatric investigation plan (PIP): Veklury, remdesivir
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Infectious diseases
PIP number: EMEA-002826-PIP01-20-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion, Powder for concentrate for solution for infusion
Decision date: 09/08/2021, Last updated: 19/08/2021, Compliance check: XCoronavirus disease 2019 (COVID-19) Route(s) of administration … coronavirus disease 2019 (COVID-19) Authorised indication(s … Coronavirus disease 2019 (COVID-19) 2.1.1. Indication(s … -
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Opinion/decision on a Paediatric investigation plan (PIP): (1R,2S,5S)-N-((1S)-1-Cyano-2-((3S)-2-oxopyrrolidin-3-yl)ethyl)-3-((2S)-3,3-dimethyl-2-(2,2,2- trifluoroacetamido)butanoyl)-6,6-dimethyl-3-azabicyclo[3.1.0]hexane-2-carboxamide
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-003081-PIP01-21, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral dosage form
Decision date: 21/12/2021, Last updated: 07/01/2021, Compliance check: XCoronavirus disease 2019 (COVID-19) Treatment of Coronavirus … Coronavirus disease 2019 (COVID-19) Route(s) of administration … -
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Opinion/decision on a Paediatric investigation plan (PIP): Etesevimab
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-002966-PIP01-21, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 09/06/2021, Last updated: 17/06/2021, Compliance check: XCoronavirus disease 2019 (COVID-19) Intravenous use Eli Lilly … EMA/245824/2021 Generic Topics: COVID-19 Paediatrics … Coronavirus disease 2019 (COVID-19) Pharmaceutical form(s … -
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Opinion/decision on a Paediatric investigation plan (PIP): Bamlanivimab
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-002952-PIP01-21, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 09/06/2021, Last updated: 17/06/2021, Compliance check: XCoronavirus disease 2019 (COVID-19) Intravenous use Eli Lilly … EMA/245846/2021 Generic Topics: COVID-19 Paediatrics … Coronavirus disease 2019 (COVID-19) Pharmaceutical form(s … -
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Opinion/decision on a Paediatric investigation plan (PIP): Regdanvimab
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-002961-PIP01-21, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 08/06/2021, Last updated: 17/06/2021, Compliance check: XCoronavirus disease 2019 (COVID-19) Intravenous use Celltrion … EMA/308829/2021 Generic Topics: COVID-19 Paediatrics … Coronavirus disease 2019 (COVID-19) Pharmaceutical form(s … -
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Opinion/decision on a Paediatric investigation plan (PIP): Molnupiravir
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-002940-PIP01-20, Route(s) of administration: Oral use, Gastric use, Pharmaceutical form(s): Capsule, hard, Age-appropriate dosage form, other
Decision date: 12/08/2021, Last updated: 19/08/2021, Compliance check: XCoronavirus disease 2019 (COVID-19) Oral use Gastric use … EMA/444418/2021 Generic Topics: COVID-19 Paediatrics … coronavirus disease 2019 (COVID-19) Pharmaceutical form(s … -
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Opinion/decision on a Paediatric investigation plan (PIP): SARS-CoV2 prefusion Spike delta TM (CoV-2 preS dTM) adjuvanted with AS03
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-002915-PIP01-20, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Solution and emulsion for emulsion for injection
Decision date: 10/05/2021, Last updated: 19/05/2021, Compliance check: XCoronavirus disease 2019 (COVID-19) Intramuscular use Sanofi … EMA/190499/2021 Generic Topics: COVID-19 Paediatrics Vaccines … coronavirus disease 2019 (COVID-19) Pharmaceutical form(s … -
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Opinion/decision on a Paediatric investigation plan (PIP): Severe acute respiratory syndrome coronavirus 2 recombinant spike protein nanoparticle vaccine (SARS-CoV-2 rS) / matrix-M1 adjuvant
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-002941-PIP01-20, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 15/03/2021, Last updated: 16/03/2021, Compliance check: XCoronavirus disease 2019 (COVID-19) Intramuscular use Novavax … Related content Topics: COVID-19 Paediatrics … coronavirus disease 2019 (COVID-19) Pharmaceutical form(s … -
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2020 annual meeting of the members and Coordinating Group of the European network of paediatric research at the EMA (Enpr-EMA)
Virtual meeting, 28/09/2020, Last updated: 16/12/2020continuity plan related to COVID-19. The European Commission provided … focused on the impact of COVID-19 in the paediatric population … Rare Bone Diseases during COVID-19 pandemic (L. Sangiorgi) PDF … -
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Paediatric investigation plans
Last updated: 15/04/2021rights. Rapid procedure for COVID-19 treatments and vaccines For … evaluation procedures for COVID-19 treatments and vaccines … treatments and vaccines for COVID-19. The EMA emerging health …
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European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting
Virtual meeting, 02/03/2021, Last updated: 25/03/2021research during the ongoing COVID-19 pandemic and an exchange … exchange about paediatric COVID-19 vaccine development. Documents … Agency (Enpr-EMA) Topics: COVID-19 Paediatrics … -
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2021 annual meeting of the members and Coordinating Group of the European network of paediatric research at the EMA (Enpr-EMA)
Virtual meeting, 28/09/2021, Last updated: 09/11/2021annual Enpr-EMA workshop due to the COVID-19 pandemic . It aimed to promote dialogue … European Commission; the latest COVID-19-related developments in relation … Rodriguez For discussion 16:15 COVID-19 affecting children: • …