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213 results
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Withdrawn application: Keytruda
pembrolizumab, date of withdrawal: 10/12/2019, Post-authorisation, Last updated: 19/03/2020 -
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Withdrawn application: Zydelig
idelalisib, date of withdrawal: 30/01/2018, Post-authorisation, Last updated: 23/02/2018 -
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Withdrawn application: Keytruda
pembrolizumab, date of withdrawal: 11/10/2017, Post-authorisation, Last updated: 28/11/2017 -
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Withdrawn application: Translarna
ataluren, date of withdrawal: 06/03/2017, Post-authorisation, Last updated: 24/03/2017 -
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Withdrawn application: Rienso
ferumoxytol, date of withdrawal: 19/01/2015, Post-authorisation, Last updated: 27/02/2015 -
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Withdrawn application: Omontys
date of withdrawal: 28/06/2013, Initial authorisation, Last updated: 28/06/2013 -
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Withdrawn application: Memantine FGK
memantine, date of withdrawal: 18/12/2012, Initial authorisation, Last updated: 10/04/2013 -
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Withdrawn application: Revlimid
lenalidomide, date of withdrawal: 20/06/2012, Post-authorisation, Last updated: 06/07/2012 -
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Withdrawn application: Evoltra
clofarabine, date of withdrawal: 18/03/2008, Post-authorisation, Last updated: 19/03/2008 -
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Withdrawn application: Glivec
imatinib, date of withdrawal: 18/10/2006, Post-authorisation, Last updated: 23/10/2006 -
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Withdrawn application: Tecentriq
atezolizumab, date of withdrawal: 22/10/2018, Post-authorisation, Last updated: 16/11/2018 -
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Withdrawn application: Axumin
fluciclovine (18F), date of withdrawal: 11/02/2020, Post-authorisation, Last updated: 28/02/2020 -
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Withdrawn application: Tecentriq
atezolizumab, date of withdrawal: 08/01/2021, Post-authorisation, Last updated: 01/02/2021 -
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Withdrawn application: Tecentriq (new)
atezolizumab, date of withdrawal: 23/06/2021, Post-authorisation, Last updated: 23/07/2021 -
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Opinion/decision on a Paediatric investigation plan (PIP): Darzalex, Daratumumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002152-PIP01-17-M02, Route(s) of administration: Subcutaneous use, Intravenous use, Pharmaceutical form(s): Solution for injection, Concentrate for solution for infusion
Decision date: 22/10/2020, Last updated: 23/07/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Ultomiris, ravulizumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology, Uro-nephrology
PIP number: EMEA-002077-PIP01-16-M03, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Concentrate for solution for infusion, Solution for injection
Decision date: 23/10/2020, Last updated: 23/07/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Ultomiris, ravulizumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology, Uro-nephrology
PIP number: EMEA-001943-PIP01-16-M05, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Concentrate for solution for infusion, Solution for infusion
Decision date: 28/10/2020, Last updated: 23/07/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Dupixent, dupilumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001501-PIP02-13-M06, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 22/10/2020, Last updated: 23/07/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Lenvima, Lenvatinib (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001119-PIP02-12-M07, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 21/10/2020, Last updated: 21/07/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Lamzede, velmanase alfa (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001056-PIP02-12-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 23/10/2020, Last updated: 21/07/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Zeposia, Ozanimod (hydrochloride) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001710-PIP03-17-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Age-appropriate oral solid dosage form
Decision date: 24/09/2020, Last updated: 09/07/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Sirturo, bedaquiline fumarate (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000912-PIP01-10-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Granules
Decision date: 09/09/2020, Last updated: 08/07/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Soliris, Eculizumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000876-PIP05-15-M04, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 29/09/2020, Last updated: 08/07/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Wakix, pitolisant (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-001176-PIP01-11-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 27/01/2021, Last updated: 05/07/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Zolgensma, onasemnogene abeparvovec (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-002168-PIP01-17-M03, Route(s) of administration: Intravenous use, Intrathecal use, Pharmaceutical form(s): Solution for injection/infusion
Decision date: 09/09/2020, Last updated: 02/07/2021, Compliance check: X