For help on how to get the results you want, see our search tips.
204 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Withdrawn applications Remove Withdrawn applications filter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Withdrawn application: Keytruda
pembrolizumab, date of withdrawal: 10/12/2019, Post-authorisation, Last updated: 19/03/2020 -
List item
Withdrawn application: Zydelig
idelalisib, date of withdrawal: 30/01/2018, Post-authorisation, Last updated: 23/02/2018 -
List item
Withdrawn application: Keytruda
pembrolizumab, date of withdrawal: 11/10/2017, Post-authorisation, Last updated: 28/11/2017 -
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Withdrawn application: Translarna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Withdrawn application: Rienso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Withdrawn application: Revlimid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Withdrawn application: Epostim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Withdrawn application: Evoltra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Withdrawn application: Glivec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Withdrawn application: Teriparatide Cinnagen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Withdrawn application: Tecentriq
atezolizumab, date of withdrawal: 22/10/2018, Post-authorisation, Last updated: 16/11/2018 -
List item
Withdrawn application: Tecentriq
atezolizumab, date of withdrawal: 08/01/2021, Post-authorisation, Last updated: 01/02/2021 -
List item
Withdrawn application: Tecentriq
atezolizumab, date of withdrawal: 23/06/2021, Post-authorisation, Last updated: 23/07/2021 -
List item
Withdrawn application: Axumin
fluciclovine (18F), date of withdrawal: 11/02/2020, Post-authorisation, Last updated: 28/02/2020 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Waylivra, Volanesorsen (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001915-PIP01-15-M03, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 14/04/2021, Last updated: 18/01/2022, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Rinvoq, upadacitinib (updated)
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): Rinvoq, upadacitinib (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-001741-PIP01-14-M04, 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: 14/04/2021, Last updated: 18/01/2022, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Palforzia, defatted powder of Arachis hypogaea L., semen (peanuts) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001734-PIP01-14-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral powder, Capsule, hard
Decision date: 14/04/2021, Last updated: 18/01/2022, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Delstrigo, doravirine, lamivudine, tenofovir disoproxil (fumarate) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001695-PIP01-14-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Granules
Decision date: 12/04/2021, Last updated: 18/01/2022, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Pifeltro, doravirine (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001676-PIP01-14-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Granules
Decision date: 12/04/2021, Last updated: 18/01/2022, Compliance check: X -
List item
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 -
List item
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 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Reagila, Cariprazine (hydrochloride)
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Psychiatry
PIP number: EMEA-001652-PIP01-14-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 17/03/2021, Last updated: 26/11/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Ilumetri, tildrakizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Dermatology
PIP number: EMEA-001451-PIP01-13-M01, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 17/03/2021, Last updated: 26/11/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Ibrance, palbociclib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002146-PIP01-17-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral dosage form, Capsule, hard, Film-coated tablet
Decision date: 17/03/2021, Last updated: 19/11/2021, Compliance check: X