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216 results
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Summary of opinion: Vegzelma
bevacizumab, opinion date: 23/06/2022, Positive, Last updated: 21/06/2022 -
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Summary of opinion: Lyumjev (previously Liumjev)
insulin lispro, opinion date: 13/10/2022, Positive, Last updated: 14/10/2022 -
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Summary of opinion: Enhertu
trastuzumab deruxtecan, opinion date: 10/11/2022, Positive, Last updated: 11/11/2022 -
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Summary of opinion: Imcivree
setmelanotide, opinion date: 21/07/2022, Positive, Last updated: 22/07/2022 -
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Summary of opinion: Libtayo
cemiplimab, opinion date: 13/10/2022, Positive, Last updated: 14/10/2022 -
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Summary of opinion: Kerendia
finerenone, opinion date: 15/12/2022, Positive, Last updated: 16/12/2022 -
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Summary of opinion: Enhertu
trastuzumab deruxtecan, opinion date: 15/12/2022, Positive, Last updated: 14/12/2022 -
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Summary of opinion: Hemlibra
emicizumab, opinion date: 15/12/2022, Positive, Last updated: 16/12/2022 -
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Summary of opinion: Fintepla
fenfluramine, opinion date: 15/12/2022, Positive, Last updated: 16/12/2022 -
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Summary of opinion: Brukinsa
zanubrutinib, opinion date: 15/09/2022, Positive, Last updated: 16/09/2022 -
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Summary of opinion: Imfinzi
durvalumab, opinion date: 10/11/2022, Positive, Last updated: 11/11/2022 -
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Summary of opinion: Imfinzi
durvalumab, opinion date: 15/12/2022, Positive, Last updated: 16/12/2022 -
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Summary of opinion: Imfinzi
durvalumab, opinion date: 15/12/2022, Positive, Last updated: 16/12/2022 -
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Summary of opinion: Xofluza
baloxavir marboxil, opinion date: 10/11/2022, Positive, Last updated: 11/11/2022 -
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Summary of opinion: Comirnaty
tozinameran, riltozinameran and tozinameran, famtozinameran and tozinameran, COVID-19 mRNA Vaccine (nucleoside modified), opinion date: 19/10/2022, Positive, Last updated: 19/10/2022 -
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Summary of opinion: Wakix (new)
pitolisant, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023 -
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Summary of opinion: Reblozyl (new)
luspatercept, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023 -
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Summary of opinion: Nubeqa (new)
darolutamide, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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