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109 results
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Summary of opinion: Sohonos
palovarotene, opinion date: 26/01/2023, Negative, Last updated: 13/02/2023 -
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Summary of opinion: Meloxoral
meloxicam, opinion date: 06/10/2022, Positive, Last updated: 07/10/2022 -
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Summary of opinion: Pombiliti
cipaglucosidase alfa, opinion date: 15/12/2022, Positive, Last updated: 16/12/2022 -
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Summary of opinion: Omblastys
iodine (131I) omburtamab, opinion date: 15/12/2022, Negative, Last updated: 16/12/2022 -
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Summary of opinion: Trecondi
treosulfan, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023 -
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Summary of opinion: Wakix
pitolisant, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023 -
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Summary of opinion: Dapagliflozin Viatris
dapagliflozin, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023 -
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Summary of opinion: Tolvaptan Accord
tolvaptan, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023 -
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Summary of opinion: Sitagliptin / Metformin hydrochloride Sun
sitagliptin, metformin hydrochloride, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023 -
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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: Dimethyl fumarate Accord
dimethyl fumarate, opinion date: 15/12/2022, Positive, Last updated: 16/12/2022 -
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Summary of opinion: Tibsovo
ivosidenib, opinion date: 23/02/2023, Positive, Last updated: 24/02/2023 -
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Summary of opinion: Tidhesco
ivosidenib, opinion date: 23/02/2023, Positive, Last updated: 24/02/2023 -
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Summary of opinion: Elfabrio
pegunigalsidase alfa, opinion date: 23/02/2023, Positive, Last updated: 24/02/2023 -
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Summary of opinion: Bekemv
eculizumab, opinion date: 23/02/2023, Positive, Last updated: 24/02/2023 -
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Summary of opinion: Hyftor
sirolimus, opinion date: 23/02/2023, Positive, Last updated: 24/02/2023 -
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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: Vegzelma
bevacizumab, opinion date: 23/06/2022, Positive, Last updated: 21/06/2022 -
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Summary of opinion: Lacosamide Adroiq (new)
lacosamide, opinion date: 30/03/2023, Positive, Last updated: 31/03/2023 -
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Summary of opinion: Epysqli (new)
opinion date: 30/03/2023, Positive, Last updated: 31/03/2023 -
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Summary of opinion: Sugammadex Adroiq (new)
sugammadex, opinion date: 30/03/2023, Positive, Last updated: 31/03/2023 -
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Summary of opinion: Dabigatran Etexilate Accord (new)
dabigatran etexilate, opinion date: 30/03/2023, Positive, Last updated: 31/03/2023 -
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Opinion/decision on a Paediatric investigation plan (PIP): Besponsa, inotuzumab ozogamicin (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology; Oncology
PIP number: EMEA-001429-PIP01-13-M04, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 03/12/2021, Last updated: 28/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Cresemba, Isavuconazonium sulfate (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001301-PIP02-12-M04, Route(s) of administration: Intravenous use, Oral use, Pharmaceutical form(s): Powder for solution for infusion, Capsule, hard
Decision date: 03/12/2021, Last updated: 28/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Idefirix, Imlifidase (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-002183-PIP01-17-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 11/03/2022, Last updated: 23/03/2023, Compliance check: X