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Opinion/decision on a Paediatric investigation plan (PIP): Regkirona, Regdanvimab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-002961-PIP01-21-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 13/05/2022, Last updated: 12/05/2023, Compliance check: X -
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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: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Ronapreve, Imdevimab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002965-PIP01-21-M01, Route(s) of administration: Subcutaneous use, Intravenous use, Pharmaceutical form(s): Solution for injection/infusion
Decision date: 03/02/2022, Last updated: 17/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Ronapreve, Casirivimab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002964-PIP01-21-M01, Route(s) of administration: Subcutaneous use, Intravenous use, Pharmaceutical form(s): Solution for injection/infusion
Decision date: 03/02/2022, Last updated: 17/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Cilgavimab (AZD1061)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002925-PIP01-20-M01, Route(s) of administration: Intramuscular use, Intravenous use, Pharmaceutical form(s): Solution for injection/infusion
Decision date: 11/02/2022, Last updated: 17/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): VidPrevtyn Beta, SARS-CoV2 prefusion Spike delta TM (CoV-2 preS dTM) adjuvanted with AS03
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-002915-PIP01-20-M01, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Solution and emulsion for emulsion for injection
Decision date: 14/02/2022, Last updated: 17/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Tixagevimab (AZD8895)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002900-PIP01-20-M01, Route(s) of administration: Intramuscular use, Intravenous use, Pharmaceutical form(s): Solution for injection
Decision date: 11/02/2022, Last updated: 17/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Nuvaxovid, Severe acute respiratory syndrome coronavirus 2 recombinant spike protein nanoparticle vaccine/ matrix-M1 adjuvant (NVX-CoV2373)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-002941-PIP01-20-M01, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 03/12/2021, Last updated: 29/03/2023, Compliance check: X -
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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-M02, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 27/12/2021, Last updated: 28/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Comirnaty, Tozinameran
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002861-PIP02-20-M03, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Concentrate for solution for injection
Decision date: 31/12/2021, Last updated: 27/03/2023, Compliance check: X -
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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)
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: X -
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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: X -
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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: X -
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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: X -
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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: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Propan-2-yl (2S)-2-{[(S)-({(2R,3R,4R,5R)-5-[2-amino-6-(methylamino)-9H-purin-9-yl]-4-fluoro-3- hydroxy-4-methyloxolan-2-yl}methoxy)(phenoxy)phosphoryl]amino}propanoate; sulfuric acid (2:1) (AT-527 / RO7496998)
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-002963-PIP01-21, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral dosage form, Tablet
Decision date: 29/10/2021, Last updated: 20/02/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Plitidepsin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Infectious diseases
PIP number: EMEA-000095-PIP02-21, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for concentrate for solution for infusion
Decision date: 03/12/2021, Last updated: 02/03/2023, Compliance check: X -
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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-PIP02-21, Route(s) of administration: Oral use, Gastric use, Pharmaceutical form(s): Capsule, hard, Age-appropriate dosage form
Decision date: 31/12/2021, Last updated: 10/03/2023, Compliance check: X -
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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: X -
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Opinion/decision on a Paediatric investigation plan (PIP): RoActemra, tocilizumab
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-000309-PIP07-21, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 27/07/2021, Last updated: 19/08/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Virus-like particle of SARS-CoV-2 spike protein (recombinant, adjuvant) (CoVLP) (new)
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-003008-PIP01-21, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension and emulsion for emulsion for injection
Decision date: 13/05/2022, Last updated: 11/05/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Forxiga, dapagliflozin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Infectious diseases
PIP number: EMEA-000694-PIP05-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 01/12/2020, Last updated: 19/08/2021, Compliance check: X