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25 results
Medicine
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Paediatric investigation plans Remove Paediatric investigation plans filter
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PIP decision type
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
RPM: decision refers to a refusal on the application for modification of an agreed PIP Remove RPM: decision refers to a refusal on the application for modification of an agreed PIP filter
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Opinion/decision on a Paediatric investigation plan (PIP): Zynteglo, betibeglogene autotemcel (updated)
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001665-PIP01-14-M06, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for infusion
Decision date: 13/05/2022, Last updated: 16/05/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Trelegy Ellipta, fluticasone furoate, umeclidinium bromide, vilanterol trifenatate
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-002153-PIP01-17-M01, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Inhalation powder, pre-dispensed
Decision date: 14/02/2020, Last updated: 10/12/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Obizur, susoctocog alfa
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-000753-PIP02-16, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 19/12/2017, Last updated: 29/11/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Ocaliva, Obeticholic acid
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-001304-PIP03-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral solid dosage form, Tablet
Decision date: 11/04/2018, Last updated: 25/07/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Soliris, Eculizumab
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-000876-PIP06-15, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 28/07/2016, Last updated: 20/04/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Soliris, Eculizumab
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-000876-PIP07-15, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 01/09/2016, Last updated: 27/10/2016, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): BindRen, colestilan
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-000878-PIP02-11, Route(s) of administration: Oral use, Pharmaceutical form(s): Granules, Film-coated tablet
Decision date: 01/09/2011, Last updated: 29/01/2015, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Glivec, imatinib mesilate
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-000463-PIP02-10, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Capsule, hard, Age-appropriate oral solid dosage form
Decision date: 08/04/2011, Last updated: 12/05/2011, Compliance check: X -
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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: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Talzenna, talazoparib
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-002066-PIP01-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 09/06/2021, Last updated: 26/04/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Gavreto, pralsetinib
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-002575-PIP02-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 09/07/2021, Last updated: 22/07/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Gazyvaro, Obinutuzumab
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-001207-PIP02-19, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 28/01/2021, Last updated: 29/09/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Lutathera, lutetium (177Lu) oxodotreotide
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-002950-PIP01-20, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 03/12/2021, Last updated: 10/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Ultomiris, ravulizumab
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-001943-PIP04-20, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 21/12/2021, Last updated: 06/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Opsumit, Macitentan
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-001032-PIP03-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Dispersible tablet
Decision date: 09/07/2021, Last updated: 20/07/2022, 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): Takhzyro, lanadelumab
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-001864-PIP03-19, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 01/12/2020, Last updated: 17/09/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Ultomiris, ravulizumab
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001943-PIP02-20, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion, Solution for injection
Decision date: 30/09/2021, Last updated: 10/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Enspryng, satralizumab
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-001625-PIP02-21, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 03/12/2021, Last updated: 06/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Kyprolis, carfilzomib
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Haematology-Hemostaseology; Oncology
PIP number: EMEA-001806-PIP04-19, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 27/01/2021, Last updated: 29/09/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Pelgraz, pegfilgrastim
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-002671-PIP02-20, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection in pre-filled syringe
Decision date: 10/05/2021, Last updated: 11/02/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Ozempic, semaglutide
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-001441-PIP05-20, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection in pre-filled pen
Decision date: 29/10/2021, Last updated: 10/02/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Pyrukynd, Mitapivat (new)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-002684-PIP02-21, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral solid dosage form, Film-coated tablet
Decision date: 13/05/2022, Last updated: 10/05/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Jcovden (previously COVID-19 Vaccine Janssen), 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: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Epidyolex, Cannabidiol
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-001964-PIP02-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral solution
Decision date: 18/03/2020, Last updated: 17/06/2021, Compliance check: X