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123 results
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Summary of opinion: Flynpovi (updated)
eflornithine, sulindac, opinion date: 24/06/2021, Negative, Last updated: 23/07/2021 -
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Summary of opinion: Abevmy
bevacizumab, opinion date: 25/02/2021, Positive, Last updated: 26/02/2021 -
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Summary of opinion: Lextemy
bevacizumab, opinion date: 25/02/2021, Positive, Last updated: 26/02/2021 -
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Summary of opinion: Koselugo
selumetinib, opinion date: 22/04/2021, Positive, Last updated: 23/04/2021 -
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Summary of opinion: Maviret
glecaprevir, pibrentasvir, opinion date: 22/04/2021, Positive, Last updated: 26/04/2021 -
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Summary of opinion: Bylvay
odevixibat, opinion date: 20/05/2021, Positive, Last updated: 21/05/2021 -
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Summary of opinion: Darzalex
daratumumab, opinion date: 20/05/2021, Positive, Last updated: 21/05/2021 -
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Summary of opinion: Galafold
migalastat, opinion date: 24/06/2021, Positive, Last updated: 25/06/2021 -
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Summary of opinion: Voxzogo
vosoritide, opinion date: 24/06/2021, Positive, Last updated: 25/06/2021 -
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Summary of opinion: Minjuvi
tafasitamab, opinion date: 24/06/2021, Positive, Last updated: 25/06/2021 -
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Summary of opinion: Byooviz
ranibizumab, opinion date: 24/06/2021, Positive, Last updated: 24/06/2021 -
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Summary of opinion: Abecma
idecabtagene vicleucel, opinion date: 24/06/2021, Positive, Last updated: 25/06/2021 -
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Summary of opinion: Nexviadyme (new)
Avalglucosidase alfa, opinion date: 23/07/2021, Positive, Last updated: 23/07/2021 -
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Summary of opinion: Vosevi (new)
sofosbuvir, velpatasvir, voxilaprevi, opinion date: 22/07/2021, Positive, Last updated: 23/07/2021 -
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Summary of opinion: Deltyba (new)
delamanid, opinion date: 22/07/2021, Positive, 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): 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): 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): Trecondi, Treosulfan (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation, Oncology
PIP number: EMEA-000883-PIP01-10-M05, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution
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 -
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Opinion/decision on a Paediatric investigation plan (PIP): Epidyolex, Cannabidiol (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-001964-PIP01-16-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral solution
Decision date: 09/09/2020, Last updated: 01/07/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Ondexxya, andexanet alfa (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001902-PIP01-15-M04, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 09/09/2020, Last updated: 01/07/2021, Compliance check: X