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209 results
Medicine
Paediatric investigation plans Remove Paediatric investigation plans filter
Opinions on medicines for use outside EU Remove Opinions on medicines for use outside EU filter
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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: Ronapreve
casirivimab, imdevimab, opinion date: 26/04/2023, Positive, Last updated: 26/04/2023 -
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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: Ryeqo
relugolix, estradiol, norethisterone acetate, 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: Jemperli
dostarlimab, opinion date: 12/10/2023, Positive, Last updated: 13/10/2023 -
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Summary of opinion: Veyvondi
vonicog alfa, opinion date: 12/10/2023, Positive, Last updated: 13/10/2023 -
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Summary of opinion: Brukinsa
zanubrutinib, opinion date: 12/10/2023, Positive, Last updated: 13/10/2023 -
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Summary of opinion: Fluad Tetra (new)
influenza vaccine (surface antigen, inactivated, adjuvanted), opinion date: 10/11/2023, Positive, Last updated: 10/11/2023 -
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Summary of opinion: Evkeeza (new)
evinacumab, opinion date: 09/11/2023, Positive, Last updated: 10/11/2023 -
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Summary of opinion: Talzenna (new)
talazoparib, opinion date: 09/11/2023, Positive, Last updated: 10/11/2023 -
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Summary of opinion: NexoBrid (new)
concentrate of proteolytic enzymes enriched in bromelain, opinion date: 09/11/2023, Positive, Last updated: 10/11/2023 -
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Opinion/decision on a Paediatric investigation plan (PIP): Kisplyx, Lenvatinib (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001119-PIP03-19-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 30/12/2022, Last updated: 13/11/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Rinvoq, Upadacitinib (ABT-494) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology; Immunology-Rheumatology-Transplantation
PIP number: EMEA-001741-PIP02-16-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Prolonged-release tablet, Age-appropriate oral pharmaceutical form
Decision date: 06/12/2022, Last updated: 13/11/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Skyrizi, Risankizumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001776-PIP01-15-M01, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Concentrate for solution for infusion, Solution for injection, Age-appropriate dosage form for parenteral use
Decision date: 02/12/2022, Last updated: 13/11/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Xenleta, Lefamulin (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002075-PIP01-16-M03, Route(s) of administration: Intravenous use, Oral use, Pharmaceutical form(s): Concentrate for solution for infusion, Age-appropriate oral solid dosage form, Coated tablet
Decision date: 30/12/2022, Last updated: 13/11/2023, 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-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): Mayzent, Siponimod (hemifumarate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000716-PIP01-09-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 30/12/2022, Last updated: 25/10/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Jcovden (previously COVID-19 Vaccine Janssen), COVID-19 vaccine (Ad26.COV2-S (recombinant))
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases; Vaccines
PIP number: EMEA-002880-PIP01-20-M01, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection in cartridge
Decision date: 30/12/2022, Last updated: 13/10/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Kesimpta, Ofatumumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-002397-PIP01-18-M03, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 30/12/2022, Last updated: 13/10/2023, 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 -
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Opinion/decision on a Paediatric investigation plan (PIP): Leqvio, Inclisiran sodium
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-002214-PIP01-17-M01, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 02/12/2022, Last updated: 13/10/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Sarclisa, Isatuximab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002205-PIP01-17-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 02/12/2022, Last updated: 13/10/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Imvanex, Modified Vaccinia Ankara - Bavarian Nordic virus (smallpox)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-001161-PIP02-11-M02, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Suspension for injection
Decision date: 30/12/2022, Last updated: 13/10/2023, Compliance check: X