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736 results
Medicine
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Opinion/decision on a Paediatric investigation plan (PIP): Monovalent, live, recombinant, replication-incompetent adenoviral serotype 26 vectored vaccine expressing the full length glycoprotein of the Ebola virus Mayinga variant [Ad26.ZEBOV]
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002307-PIP01-17-M01, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 17/04/2020, Last updated: 09/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Mirikizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Dermatology
PIP number: EMEA-002208-PIP01-17-M01, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Concentrate for solution for infusion, Solution for injection
Decision date: 15/04/2020, Last updated: 09/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Crisaborole
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Dermatology
PIP number: EMEA-002065-PIP01-16-M02, Route(s) of administration: Topical use, Pharmaceutical form(s): Ointment
Decision date: 16/04/2021, Last updated: 09/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Yescarta, axicabtagene ciloleucel
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002010-PIP01-16-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for infusion
Decision date: 15/04/2020, Last updated: 09/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Macimorelin Aeterna Zentaris, Macimorelin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001988-PIP01-16-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Granules for oral solution
Decision date: 06/04/2020, Last updated: 08/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Tralokinumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Dermatology
PIP number: EMEA-001900-PIP02-17-M03, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 15/04/2020, Last updated: 08/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti CD19 CD28/CD3-zeta chimeric antigen receptor and cultured (KTE-X19)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001862-PIP01-15-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for injection
Decision date: 18/04/2020, Last updated: 08/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Emgality, Galcanezumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-001860-PIP03-16-M04, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 15/04/2020, Last updated: 08/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Elafibranor
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001857-PIP01-15-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Coated tablet
Decision date: 17/04/2020, Last updated: 08/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Copanlisib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001757-PIP02-15-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 15/04/2020, Last updated: 08/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Palovarotene
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001662-PIP01-14-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 15/04/2020, Last updated: 05/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Roxadustat
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001557-PIP01-13-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 16/04/2020, Last updated: 05/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Ozempic, semaglutide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001441-PIP01-13-M03, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 18/04/2020, Last updated: 05/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Etrolizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001434-PIP01-13-M03, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 30/04/2020, Last updated: 05/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Stivarga, regorafenib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001178-PIP01-11-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Granules
Decision date: 17/04/2020, Last updated: 05/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Constella, linaclotide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-000927-PIP01-10-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 15/04/2020, Last updated: 05/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Multivalent, live, recombinant, non-replicating in human cells, Modified Vaccinia Ankara vectored vaccine, expressing the EBOV Mayinga glycoprotein, the Sudan virus Gulu GP, the Marburg virus Musoke GP, and the Taï Forest virus nucleoprotein [MVA-BN-Filo]
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002308-PIP01-17-M01, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 17/04/2020, Last updated: 05/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Xeljanz, Tofacitinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-000576-PIP03-12-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Oral solution, Prolonged-release film-coated tablet, Prolonged-release age-appropriate oral formulation
Decision date: 24/04/2020, Last updated: 05/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Blincyto, blinatumomab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-000574-PIP02-12-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 18/04/2020, Last updated: 05/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Kalydeco, ivacaftor
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-000335-PIP01-08-M14, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Granules in sachet
Decision date: 17/04/2020, Last updated: 05/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): isoflurane
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neonatology-Paediactric Intensive care
PIP number: EMEA-002320-PIP01-17-M01, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Inhalation vapour, liquid
Decision date: 15/05/2020, Last updated: 04/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Setmelanotide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Nutrition
PIP number: EMEA-002209-PIP01-17-M01, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 15/05/2020, Last updated: 04/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Monovalent, recombinant, replication-incompetent human adenovirus serotype 26-vectored vaccine encoding the pre-fusion conformation-stabilised F protein derived from the RSV A2 strain
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases, Vaccines
PIP number: EMEA-002172-PIP02-17-M01, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Solution for injection
Decision date: 20/05/2020, Last updated: 04/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Xospata, Gilteritinib (as fumarate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-002064-PIP01-16-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral dosage form
Decision date: 13/05/2020, Last updated: 04/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Alicaforsen
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-002060-PIP02-17-M01, Route(s) of administration: Rectal use, Pharmaceutical form(s): Rectal solution
Decision date: 15/05/2020, Last updated: 04/03/2021, Compliance check: X