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235 results
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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: Refixia
nonacog beta pegol, opinion date: 22/06/2023, Positive, Last updated: 23/06/2023 -
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Summary of opinion: Ronapreve
casirivimab, imdevimab, opinion date: 26/04/2023, Positive, Last updated: 26/04/2023 -
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Summary of opinion: Camzyos
mavacamten, opinion date: 26/04/2023, Positive, Last updated: 26/04/2023 -
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Summary of opinion: Kaftrio (new)
ivacaftor, tezacaftor, elexacaftor, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
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Summary of opinion: Kalydeco (new)
ivacaftor, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
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Summary of opinion: Takhzyro (new)
lanadelumab, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
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Summary of opinion: Ryeqo (new)
relugolix, estradiol, norethisterone acetate, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
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Summary of opinion: Voxzogo (new)
vosoritide, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
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Summary of opinion: Enhertu (new)
trastuzumab deruxtecan, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
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Opinion/decision on a Paediatric investigation plan (PIP): Xofluza, Baloxavir marboxil (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002440-PIP01-18-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Granules for oral suspension
Decision date: 09/09/2022, Last updated: 20/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Benlysta, belimumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000520-PIP02-13-M04, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 09/09/2022, Last updated: 19/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Lojuxta, Lomitapide (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001124-PIP01-10-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 19/09/2022, Last updated: 19/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Veyvondi, vonicog alfa (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001164-PIP01-11-M06, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 07/09/2022, Last updated: 19/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Vocabria, Cabotegravir (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001418-PIP01-13-M05, Route(s) of administration: Intramuscular use, Oral use, Pharmaceutical form(s): Age-appropriate oral dosage form, Film-coated tablet, Prolonged-release suspension for injection
Decision date: 09/09/2022, Last updated: 19/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Evkeeza, Evinacumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-002298-PIP01-17-M04, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 09/09/2022, Last updated: 18/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Imfinzi, durvalumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002028-PIP01-16-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 09/09/2022, Last updated: 18/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Piqray, Alpelisib (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-002016-PIP03-19-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Granules
Decision date: 30/09/2022, Last updated: 18/09/2023, 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: Neurology
PIP number: EMEA-001710-PIP02-14-M07, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Age-appropriate oral solid dosage form
Decision date: 09/09/2022, Last updated: 18/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Crysvita, Burosumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001659-PIP01-15-M06, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 30/09/2022, Last updated: 18/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Rekambys, rilpivirine (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000317-PIP02-18-M01, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Prolonged release suspension for injection
Decision date: 09/09/2022, Last updated: 14/09/2023, 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-M08, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 10/08/2022, Last updated: 13/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Cometriq, cabozantinib (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001143-PIP01-11-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral solid dosage form, Tablet, Capsule, hard
Decision date: 11/08/2022, Last updated: 13/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Gazyvaro, Obinutuzumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-001207-PIP02-19-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 10/08/2022, Last updated: 13/09/2023, Compliance check: X