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1661 results
Medicine
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PIP decision type
W: decision granting a waiver in all age groups for all conditions or indications Remove W: decision granting a waiver in all age groups for all conditions or indications filter
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s) Remove P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s) filter
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Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-(1-(6-Amino-5-chloropyrimidine-4-carboxamido)ethyl)-N-(5-chloro-4-(trifluoromethyl)pyridin-2-yl)thiazole-5-carboxamide (DAY101) (updated)
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-002763-PIP01-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral formulation, Tablet
Decision date: 22/12/2020, Last updated: 05/05/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): abelacimab
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-003017-PIP01-21, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Concentrate for solution for injection
Decision date: 13/04/2022, Last updated: 25/04/2023, 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): Tabelecleucel
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-002025-PIP04-19, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for injection
Decision date: 21/12/2020, Last updated: 29/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Dupixent, dupilumab
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oto-rhino-laryngology
PIP number: EMEA-001501-PIP08-20, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 17/03/2021, Last updated: 28/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Loncastuximab tesirine
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-002665-PIP02-20, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 01/10/2021, Last updated: 14/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Eylea, aflibercept
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-000236-PIP05-18, Route(s) of administration: Intravitreal use, Pharmaceutical form(s): Solution for injection
Decision date: 04/04/2019, Last updated: 13/03/2023, Compliance check: V, 15/10/2021 -
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Opinion/decision on a Paediatric investigation plan (PIP): surufatinib
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-002750-PIP01-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Powder for oral suspension
Decision date: 14/04/2021, Last updated: 17/02/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Adeno-associated viral vector serotype 8 containing the human MTM1 gene (resamirigene bilparvovec)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Other
PIP number: EMEA-002571-PIP01-19, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 14/08/2020, Last updated: 31/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Relamorelin
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-002323-PIP02-19, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Age-appropriate oral dosage form, Solution for injection
Decision date: 09/09/2020, Last updated: 12/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): vaborbactam
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-001740-PIP01-14, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 22/10/2015, Last updated: 11/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): N-hydroxy-5-methylfuran-2-sulfonamide (BMS-986231)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002378-PIP01-18, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion, Age-appropriate dosage form for parenteral use
Decision date: 22/03/2019, Last updated: 09/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Olumiant, Baricitinib
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-001220-PIP05-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Age-appropriate oral formulation
Decision date: 18/03/2020, Last updated: 09/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Fasenra, Benralizumab
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001214-PIP05-19, Route(s) of administration: Subcutaneous use, Intravenous use, Pharmaceutical form(s): Solution for injection, Solution for injection/infusion, Age-appropriate dosage form for parenteral use
Decision date: 08/09/2021, Last updated: 22/12/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Pradigastat
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-001333-PIP02-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 07/05/2014, Last updated: 22/12/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): ritonavir, atazanavir sulfate
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-002588-PIP01-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 04/12/2019, Last updated: 06/12/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Cendakimab
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-002640-PIP01-19, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 08/09/2021, Last updated: 02/12/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Voclosporin
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-002264-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, soft
Decision date: 17/04/2019, Last updated: 02/12/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): SER-109 (Eubacterial Spores, Purified Suspension, Encapsulated)
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-001970-PIP02-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Oral suspension
Decision date: 07/12/2018, Last updated: 23/11/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Linear single strand of deoxyribonucleic acid (encoding human retinitis pigmentosa GTPase regulator [RPGR]) packaged in a recombinant adeno-associated virus protein capsid of serotype 5 (AAV5-hRKp.RPGR)
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-002827-PIP01-20, Route(s) of administration: Ophthalmic use, Pharmaceutical form(s): Solution for injection
Decision date: 17/03/2021, Last updated: 17/11/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Entyvio, vedolizumab
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Gastroentology-Hepatology; Immunology-Rheumatology-Transplantation
PIP number: EMEA-000645-PIP03-18, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion, Solution for injection
Decision date: 14/08/2019, Last updated: 09/11/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Sparsentan
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Uro-nephrology
PIP number: EMEA-001984-PIP03-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral liquid dosage form, Tablet
Decision date: 27/01/2021, Last updated: 07/11/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Recombinant porcine factor VIII, B-domain deleted
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-000753-PIP01-11, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for injection, Powder and solvent for solution for injection
Decision date: 24/02/2012, Last updated: 10/10/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): cenobamate
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Neurology
PIP number: EMEA-002563-PIP02-19-M01, Route(s) of administration: Oral use, Parenteral use, Gastric use, Pharmaceutical form(s): Tablet, Film-coated tablet, Age-appropriate oral liquid dosage form, Age-appropriate dosage form for parenteral use
Decision date: 13/08/2021, Last updated: 14/09/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Lebrikizumab
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Dermatology
PIP number: EMEA-002536-PIP01-18-M01, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 11/08/2021, Last updated: 14/09/2022, Compliance check: X