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301 results
Medicine
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Opinion/decision on a Paediatric investigation plan (PIP): Vocabria, Cabotegravir
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001418-PIP02-15-M03, Route(s) of administration: Oral use, Intramuscular use, Pharmaceutical form(s): Film-coated tablet, Prolonged-release suspension for injection
Decision date: 17/03/2022, Last updated: 30/06/2023, Compliance check: V, 20/05/2022 -
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Opinion/decision on a Paediatric investigation plan (PIP): Wakix, pitolisant
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: 30/06/2023, Compliance check: V, 20/05/2022 -
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Opinion/decision on a Paediatric investigation plan (PIP): Entresto, sacubitril, valsartan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000316-PIP02-11-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate solid oral dosage form
Decision date: 13/08/2021, Last updated: 30/06/2023, Compliance check: V, 20/05/2022 -
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Opinion/decision on a Paediatric investigation plan (PIP): Mircera, Methoxy polyethylene glycol-epoetin beta
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-000172-PIP01-07-M03, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 31/10/2017, Last updated: 30/06/2023, Compliance check: V, 20/05/2022 -
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Opinion/decision on a Paediatric investigation plan (PIP): Lisdexamfetamine dimesilate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Psychiatry
PIP number: EMEA-000553-PIP01-09-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 17/03/2022, Last updated: 30/06/2023, Compliance check: V, 25/05/2022 -
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Opinion/decision on a Paediatric investigation plan (PIP): Mvabea, 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; Vaccines
PIP number: EMEA-002308-PIP01-17-M02, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 19/08/2021, Last updated: 30/06/2023, Compliance check: V, 24/06/2022 -
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Opinion/decision on a Paediatric investigation plan (PIP): Zabdeno, 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; Vaccines
PIP number: EMEA-002307-PIP01-17-M02, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 12/08/2021, Last updated: 30/06/2023, Compliance check: V, 24/06/2022 -
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Opinion/decision on a Paediatric investigation plan (PIP): Kymriah, tisagenlecleucel
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001654-PIP02-17-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for infusion
Decision date: 11/09/2019, Last updated: 30/06/2023, Compliance check: V, 24/06/2022 -
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Opinion/decision on a Paediatric investigation plan (PIP): human fibrinogen
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001208-PIP01-11-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for infusion
Decision date: 04/09/2017, Last updated: 30/06/2023, Compliance check: V, 24/06/2022 -
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Opinion/decision on a Paediatric investigation plan (PIP): Eliquis, Apixaban
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000183-PIP01-08-M08, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral liquid dosage form, Age-appropriate dosage form, other
Decision date: 20/05/2020, Last updated: 30/06/2023, Compliance check: V, 24/06/2022 -
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Opinion/decision on a Paediatric investigation plan (PIP): Trulicity, dulaglutide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-000783-PIP01-09-M06, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection (pre-filled pen)
Decision date: 29/10/2021, Last updated: 30/06/2023, Compliance check: V, 24/06/2022 -
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Opinion/decision on a Paediatric investigation plan (PIP): Ofev, nintedanib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology; Pneumology-allergology
PIP number: EMEA-001006-PIP05-18-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, soft
Decision date: 29/10/2021, Last updated: 30/06/2023, Compliance check: V, 22/07/2022 -
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Opinion/decision on a Paediatric investigation plan (PIP): Nifurtimox
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Infectious diseases
PIP number: EMEA-003134-PIP01-21, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 11/03/2022, Last updated: 30/06/2023, Compliance check: V, 09/09/2022 -
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Opinion/decision on a Paediatric investigation plan (PIP): artesunate
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Infectious diseases
PIP number: EMEA-002710-PIP01-19, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 14/08/2020, Last updated: 30/06/2023, Compliance check: V, 09/09/2022 -
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Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus A/turkey/Turkey/1/2005 (H5N1) NIBRG-23 strain, HA surface antigen
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Vaccines
PIP number: EMEA-002869-PIP03-21, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 13/04/2022, Last updated: 30/06/2023, Compliance check: V, 09/09/2022 -
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Opinion/decision on a Paediatric investigation plan (PIP): Takhzyro, Lanadelumab (DX-2930)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001864-PIP01-15-M07, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 10/06/2022, Last updated: 30/06/2023, Compliance check: V, 09/09/2022 -
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Opinion/decision on a Paediatric investigation plan (PIP): Dabrafenib
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Oncology
PIP number: EMEA-001147-PIP02-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Dispersible tablet
Decision date: 23/10/2020, Last updated: 30/06/2023, Compliance check: V, 27/09/2022 -
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Opinion/decision on a Paediatric investigation plan (PIP): trametinib
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Oncology
PIP number: EMEA-001177-PIP02-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Powder for oral solution
Decision date: 23/10/2020, Last updated: 30/06/2023, Compliance check: V, 27/09/2022 -
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Opinion/decision on a Paediatric investigation plan (PIP): Agomelatine
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Psychiatry
PIP number: EMEA-001181-PIP01-11-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 17/03/2021, Last updated: 30/06/2023, Compliance check: V, 14/10/2022 -
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Opinion/decision on a Paediatric investigation plan (PIP): Dopamine (hydrochloride)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases; Neonatology-Paediatric Intensive Care
PIP number: EMEA-001105-PIP01-10-M06, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection
Decision date: 10/06/2023, Last updated: 30/06/2023, Compliance check: V, 14/10/2022 -
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Opinion/decision on a Paediatric investigation plan (PIP): Soliris, Eculizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000876-PIP05-15-M05, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 11/03/2022, Last updated: 30/06/2023, Compliance check: V, 14/10/2022 -
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Opinion/decision on a Paediatric investigation plan (PIP): Briviact (in Italy: Nubriveo), Brivaracetam
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000332-PIP01-08-M16, Route(s) of administration: Oral use, Intravenous use, Pharmaceutical form(s): Film-coated tablet, Oral solution, Solution for injection
Decision date: 09/04/2021, Last updated: 30/06/2023, Compliance check: V, 14/10/2022 -
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Opinion/decision on a Paediatric investigation plan (PIP): Olumiant, Baricitinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Dermatology
PIP number: EMEA-001220-PIP03-16-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral suspension, Tablet
Decision date: 11/08/2021, Last updated: 30/06/2023, Compliance check: V, 11/11/2022 -
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Opinion/decision on a Paediatric investigation plan (PIP): Recombinant dimer of 6 kD early secretory antigenic target, recombinant 10 kD culture filtrate protein
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Diagnostic
PIP number: EMEA-001156-PIP01-11-M07, Route(s) of administration: Intradermal use, Pharmaceutical form(s): Solution for injection
Decision date: 15/07/2016, Last updated: 30/06/2023, Compliance check: V, 11/11/2022 -
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Opinion/decision on a Paediatric investigation plan (PIP): Mekinist, Trametinib (dimethyl sulfoxide)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001177-PIP01-11-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Powder for oral solution
Decision date: 23/10/2020, Last updated: 30/06/2023, Compliance check: V, 11/11/2022