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123 results
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Summary of opinion: Albrioza
sodium phenylbutyrate, Ursodoxicoltaurine, opinion date: 12/10/2023, Negative, Last updated: 13/10/2023 -
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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: Melovem
meloxicam, opinion date: 20/04/2023, Positive, Last updated: 21/04/2023 -
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Summary of opinion: Inaqovi
cedazuridine, decitabine, opinion date: 20/07/2023, Positive, Last updated: 21/07/2023 -
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Summary of opinion: Bylvay
odevixibat, opinion date: 20/07/2023, Positive, Last updated: 21/07/2023 -
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Summary of opinion: Revestive
teduglutide, opinion date: 26/04/2023, Positive, Last updated: 26/04/2023 -
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Summary of opinion: Adcetris
brentuximab vedotin, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
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Summary of opinion: Kaftrio
ivacaftor, tezacaftor, elexacaftor, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
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Summary of opinion: Yorvipath
Palopegteriparatide, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
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Summary of opinion: Finlee
dabrafenib, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
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Summary of opinion: Loargys
Pegzilarginase, opinion date: 12/10/2023, Positive, Last updated: 13/10/2023 -
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Summary of opinion: Rezzayo
rezafungin, opinion date: 12/10/2023, Positive, Last updated: 13/10/2023 -
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Summary of opinion: Spexotras (new)
trametinib, opinion date: 09/11/2023, Positive, Last updated: 10/11/2023 -
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Summary of opinion: Azacitidine Kabi (new)
azacitidine, opinion date: 10/11/2023, Positive, Last updated: 10/11/2023 -
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Summary of opinion: Rimmyrah (new)
ranibizumab, opinion date: 09/11/2023, Positive, Last updated: 10/11/2023 -
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Summary of opinion: Naveruclif (new)
paclitaxel, opinion date: 09/11/2023, Positive, Last updated: 10/11/2023 -
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Summary of opinion: Rystiggo (new)
Rozanolixizumab, opinion date: 09/11/2023, Positive, Last updated: 10/11/2023 -
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Summary of opinion: Omjjara (new)
momelotinib, opinion date: 09/11/2023, Positive, Last updated: 10/11/2023 -
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Summary of opinion: Ayvakyt (new)
avapritinib, opinion date: 09/11/2023, Positive, Last updated: 10/11/2023 -
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Summary of opinion: Prevymis
letermovir, opinion date: 12/10/2023, Positive, Last updated: 13/10/2023 -
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Summary of opinion: Agamree
Vamorolone, opinion date: 12/10/2023, Positive, Last updated: 13/10/2023 -
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Summary of opinion: Uzpruvo (new)
ustekinumab, opinion date: 09/11/2023, Positive, Last updated: 10/11/2023 -
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Summary of opinion: Takhzyro
lanadelumab, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
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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-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Granules
Decision date: 16/11/2022, Last updated: 13/11/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Oxbryta, Voxelotor
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-002356-PIP02-20-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Dispersible tablet
Decision date: 02/12/2022, Last updated: 13/10/2023, Compliance check: X