For help on how to get the results you want, see our search tips.
439 results
-
List item
Opinion/decision on a Paediatric investigation plan (PIP): Takhzyro, lanadelumab
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Other
PIP number: EMEA-001864-PIP02-19, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 18/04/2020, Last updated: 03/03/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Gazyvaro, Obinutuzumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001207-PIP01-11-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 10/05/2021, Last updated: 17/02/2022, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Gazyvaro, Obinutuzumab
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-001207-PIP03-20, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 22/12/2020, Last updated: 17/09/2021, Compliance check: X -
List item
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 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Cerdelga, Eliglustat (tartrate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-000461-PIP02-11-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 08/09/2021, Last updated: 12/01/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Praxbind, idarucizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001438-PIP01-13-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection/infusion
Decision date: 17/04/2019, Last updated: 16/09/2021, Compliance check: V, 24/07/2020 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Coagadex, Human coagulation factor X
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-000971-PIP01-10-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for injection or infusion
Decision date: 19/12/2017, Last updated: 05/03/2018, Compliance check: V, 26/01/2018 -
List item
Withdrawn application: Febseltiq
infigratinib, date of withdrawal: 11/10/2022, Initial authorisation, Last updated: 30/01/2023 -
List item
Withdrawn application: Gavreto
pralsetinib, date of withdrawal: 03/11/2022, Post-authorisation, Last updated: 02/02/2023 -
List item
Withdrawn application: Imbarkyd
bardoxolone methyl, date of withdrawal: 09/11/2022, Initial authorisation, Last updated: 07/02/2023 -
List item
Withdrawn application: Miplyffa
arimoclomol, date of withdrawal: 22/03/2022, Initial authorisation, Last updated: 08/02/2023 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Sovaldi, Sofosbuvir
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001276-PIP01-12-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form, Other
Decision date: 15/06/2018, Last updated: 21/09/2021, Compliance check: V, 26/04/2019 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Harvoni, Sofosbuvir, ledipasvir
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001411-PIP01-12-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form, Age-appropriate dosage form, other
Decision date: 16/03/2017, Last updated: 21/09/2021, Compliance check: V, 26/04/2019 -
List item
Withdrawn application: Aliqopa
copanlisib, date of withdrawal: 20/12/2021, Initial authorisation, Last updated: 10/02/2023 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Xospata, Gilteritinib (as fumarate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-002064-PIP01-16-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Film-coated tablet, Age-appropriate oral dosage form
Decision date: 17/03/2021, Last updated: 05/11/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Gavreto, pralsetinib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002575-PIP03-21, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 29/10/2021, Last updated: 13/02/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Ofev, nintedanib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology; Pneumology-allergology
PIP number: EMEA-001006-PIP05-18-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, soft
Decision date: 29/10/2021, Last updated: 13/02/2023, 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-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form
Decision date: 29/10/2021, Last updated: 13/02/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Evrysdi, Risdiplam (RO7034067)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-002070-PIP01-16-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Powder for oral solution
Decision date: 26/11/2021, Last updated: 13/02/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Ninlaro, Ixazomib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001410-PIP02-17-M03, Route(s) of administration: Intravenous use, Oral use, Gastric use, Pharmaceutical form(s): Powder for solution for injection or infusion, Capsule, hard
Decision date: 09/09/2020, Last updated: 14/11/2019, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Enhertu, trastuzumab deruxtecan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002978-PIP01-21, Route(s) of administration: All routes of administration, Pharmaceutical form(s): All pharmaceutical forms
Decision date: 08/07/2021, Last updated: 19/07/2022, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Namuscla, Mexiletine hydrochloride
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-002012-PIP01-16-M03, Route(s) of administration: Oral use, Gastric use, Pharmaceutical form(s): Capsule, hard, Oral solution
Decision date: 08/09/2021, Last updated: 12/01/2023, Compliance check: X -
List item
Withdrawn application: Tibsovo
ivosidenib, date of withdrawal: 13/10/2020, Initial authorisation, Last updated: 16/04/2021 -
List item
Withdrawn application: Garsun
artesunate, date of withdrawal: 08/12/2022, Initial authorisation, Last updated: 01/03/2023 -
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