For help on how to get the results you want, see our search tips.
180 results
Medicine
Paediatric investigation plans Remove Paediatric investigation plans filter
Withdrawn applications Remove Withdrawn applications filter
Medicine type
Biosimilar Remove Biosimilar filter
Exceptional circumstances Remove Exceptional circumstances filter
Additional monitoring Remove Additional monitoring filter
Categories
Human Remove Human filter
-
List item
Withdrawn application: Hervelous
trastuzumab, date of withdrawal: 14/09/2022, Initial authorisation, Last updated: 13/12/2022 -
List item
Withdrawn application: Tuznue
trastuzumab, date of withdrawal: 14/09/2022, Initial authorisation, Last updated: 13/12/2022 -
List item
Withdrawn application: Imcivree
setmelanotide, date of withdrawal: 22/04/2022, Post-authorisation, Last updated: 28/09/2022 -
List item
Withdrawn application: Zydelig
idelalisib, date of withdrawal: 30/01/2018, Post-authorisation, Last updated: 23/02/2018 -
List item
Withdrawn application: Translarna
ataluren, date of withdrawal: 06/03/2017, Post-authorisation, Last updated: 24/03/2017 -
List item
Withdrawn application: Rienso
ferumoxytol, date of withdrawal: 19/01/2015, Post-authorisation, Last updated: 27/02/2015 -
List item
Withdrawn application: Revlimid
lenalidomide, date of withdrawal: 20/06/2012, Post-authorisation, Last updated: 06/07/2012 -
List item
Withdrawn application: Epostim
epoetin alfa, date of withdrawal: 15/03/2011, Initial authorisation, Last updated: 19/04/2011 -
List item
Withdrawn application: Evoltra
clofarabine, date of withdrawal: 18/03/2008, Post-authorisation, Last updated: 19/03/2008 -
List item
Withdrawn application: Glivec
imatinib, date of withdrawal: 18/10/2006, Post-authorisation, Last updated: 23/10/2006 -
List item
Withdrawn application: Teriparatide Cinnagen
teriparatide, date of withdrawal: 09/09/2021, Initial authorisation, Last updated: 17/09/2021 -
List item
Withdrawn application: Gavreto
pralsetinib, date of withdrawal: 03/11/2022, Post-authorisation, Last updated: 11/11/2022 -
List item
Withdrawn application: Tookad
padeliporfin, date of withdrawal: 14/12/2021, Post-authorisation, Last updated: 28/01/2022 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Lokelma, sodium zirconium cyclosilicate (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001539-PIP01-13-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Powder for oral suspension
Decision date: 03/12/2021, Last updated: 01/02/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Trogarzo, Ibalizumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002311-PIP01-17-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 09/07/2021, Last updated: 16/01/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Retsevmo, Selpercatinib (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002544-PIP01-18-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Age-appropriate dosage form
Decision date: 30/09/2021, Last updated: 13/01/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Rozlytrek, Entrectinib (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002096-PIP01-16-M03, Route(s) of administration: Oral use, Gastric use, Pharmaceutical form(s): Capsule, hard, Coated granules
Decision date: 08/09/2021, Last updated: 12/01/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Veltassa, Patiromer calcium (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001720-PIP01-14-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Powder for oral suspension
Decision date: 08/09/2021, Last updated: 12/01/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Symkevi, tezacaftor, ivacaftor (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001640-PIP01-14-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form
Decision date: 30/09/2021, Last updated: 12/01/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Natpar, Recombinant parathyroid hormone (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001526-PIP01-13-M05, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 08/09/2021, Last updated: 12/01/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Mysimba, bupropion hydrochloride, naltrexone hydrochloride (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001373-PIP01-12-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Prolonged-release tablet
Decision date: 08/09/2021, Last updated: 12/01/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Evarrest, human fibrinogen, human thrombin (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001149-PIP01-11-M07, Route(s) of administration: Epilesional use, Pharmaceutical form(s): Solution for sealant, Sealant matrix
Decision date: 08/09/2021, Last updated: 12/01/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Cerdelga, Eliglustat (tartrate) (updated)
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): 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): Kymriah, tisagenlecleucel
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001654-PIP01-14-M04, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for infusion
Decision date: 10/06/2022, Last updated: 07/09/2022, Compliance check: X