For help on how to get the results you want, see our search tips.
193 results
Medicine type
Additional monitoring Remove Additional monitoring filter
Accelerated assessment Remove Accelerated assessment filter
Conditional approval Remove Conditional approval filter
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
PM: decision on the application for modification of an agreed PIP Remove PM: decision on the application for modification of an agreed PIP filter
-
List item
Opinion/decision on a Paediatric investigation plan (PIP): Zeposia, Ozanimod (hydrochloride)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001710-PIP04-17-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Age-appropriate oral liquid dosage form
Decision date: 13/04/2022, Last updated: 19/04/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Zeposia, Ozanimod (hydrochloride)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001710-PIP03-17-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Age-appropriate oral solid dosage form
Decision date: 08/06/2021, Last updated: 02/12/2022, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Idefirix, Imlifidase
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-002183-PIP01-17-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 11/03/2022, Last updated: 23/03/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Ayvakyt, Avapritinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002358-PIP02-18-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form
Decision date: 31/01/2022, Last updated: 12/04/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Doptelet, avatrombopag maleate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001136-PIP01-11-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Powder for oral suspension
Decision date: 22/11/2019, Last updated: 12/01/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Spravato, Esketamine (hydrochloride)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Psychiatry
PIP number: EMEA-001428-PIP03-15-M02, Route(s) of administration: Intranasal use, Pharmaceutical form(s): Nasal spray, solution
Decision date: 13/04/2022, Last updated: 19/04/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Kaftrio, elexacaftor, tezacaftor, ivacaftor
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other; Pneumology-allergology
PIP number: EMEA-002324-PIP01-17-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form
Decision date: 22/07/2022, Last updated: 13/02/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Maviret, glecaprevir, pibrentasvir
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001832-PIP01-15-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Age-appropriate oral solid dosage form
Decision date: 17/04/2019, Last updated: 21/09/2021, Compliance check: V, 11/12/2019 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Galafold, Migalastat hydrochloride
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-001194-PIP01-11-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Oral solution
Decision date: 13/04/2022, Last updated: 19/04/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Evenity, Romosozumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-001075-PIP04-15-M04, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 31/12/2021, Last updated: 16/03/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Uplizna, Inebilizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-001911-PIP01-15-M04, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion, Concentrate for solution for infusion
Decision date: 10/06/2022, Last updated: 21/06/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Regkirona, Regdanvimab
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 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Quviviq, Daridorexant
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Psychiatry
PIP number: EMEA-002121-PIP03-19-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral solid dosage form, Film-coated tablet
Decision date: 13/04/2022, Last updated: 19/04/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Aspaveli, Pegcetacoplan
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-002600-PIP03-21, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for infusion
Decision date: 11/08/2022, Last updated: 28/08/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Nulibry, Fosdenopterin (ORGN001)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001491-PIP01-13-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 13/04/2022, Last updated: 19/04/2023, Compliance check: V, 15/10/2021 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Imcivree, Setmelanotide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Nutrition
PIP number: EMEA-002209-PIP01-17-M03, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 10/08/2022, Last updated: 28/08/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Rinvoq, upadacitinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-001741-PIP01-14-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral solid dosage form, Age-appropriate oral liquid dosage form, Prolonged-release tablet
Decision date: 03/12/2021, Last updated: 21/03/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Rinvoq, Upadacitinib (ABT-494)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-001741-PIP03-16-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Prolonged-release tablet, Age-appropriate oral solid dosage form, Age-appropriate oral liquid dosage form
Decision date: 13/07/2022, Last updated: 23/06/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Rinvoq, upadacitinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Dermatology; Immunology-Rheumatology-Transplantation
PIP number: EMEA-001741-PIP04-17-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral liquid dosage form, Age-appropriate oral solid dosage form, Prolonged-release capsule, Prolonged-release tablet
Decision date: 14/04/2021, Last updated: 18/01/2022, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Bavencio, avelumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001849-PIP02-15-M04, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 31/12/2021, Last updated: 27/03/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Vydura, Rimegepant
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-002812-PIP02-20-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral lyophilisate
Decision date: 10/08/2022, Last updated: 31/08/2023, Compliance check: X -
List item
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-M02, Route(s) of administration: Subcutaneous use, Intravenous use, Pharmaceutical form(s): Solution for injection/infusion
Decision date: 10/08/2022, Last updated: 31/08/2023, Compliance check: X -
List item
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-M02, Route(s) of administration: Subcutaneous use, Intravenous use, Pharmaceutical form(s): Solution for injection/infusion
Decision date: 10/08/2022, Last updated: 31/08/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Doptelet, Avatrombopag
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001136-PIP02-19-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Powder for oral suspension
Decision date: 09/12/2020, Last updated: 01/09/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Emgality, Galcanezumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-001860-PIP03-16-M07, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 13/04/2022, Last updated: 19/04/2023, Compliance check: X