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2499 results
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Opinion/decision on a Paediatric investigation plan (PIP): Aztreonam (ATM), Avibactam (AVI) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002283-PIP01-17-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 08/09/2021, Last updated: 13/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Dasiglucagon (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-002233-PIP01-17-M01, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 08/09/2021, Last updated: 13/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Solriamfetol (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-002184-PIP01-17-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 08/09/2021, Last updated: 13/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Recombinant Clostridioides difficile toxoid A, Recombinant Clostridioides difficile toxoid B (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-002112-PIP01-16-M01, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Powder and suspension for suspension for injection
Decision date: 08/09/2021, Last updated: 12/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Rozlytrek, Entrectinib (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002096-PIP01-16-M03, Route(s) of administration: Oral use, Gastric use, Pharmaceutical form(s): Capsule, hard, Coated granules
Decision date: 08/09/2021, Last updated: 12/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Namuscla, Mexiletine hydrochloride (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-002012-PIP01-16-M03, Route(s) of administration: Oral use, Gastric use, Pharmaceutical form(s): Capsule, hard, Oral solution
Decision date: 08/09/2021, Last updated: 12/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Avalglucosidase alfa (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001945-PIP01-16-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 08/09/2021, Last updated: 12/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Naldemedine (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001893-PIP01-15-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Powder for oral suspension
Decision date: 08/09/2021, Last updated: 12/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Enerzair Breezhaler, Indacaterol (acetate), Mometasone (furoate) (QVM149), glycopyrronium bromide (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001812-PIP01-15-M01, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Inhalation powder, Capsule, hard
Decision date: 08/09/2021, Last updated: 12/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Veltassa, Patiromer calcium (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001720-PIP01-14-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Powder for oral suspension
Decision date: 08/09/2021, Last updated: 12/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Metreleptin (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001701-PIP01-14-M02, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 08/09/2021, Last updated: 12/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Symkevi, tezacaftor, ivacaftor (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001640-PIP01-14-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form
Decision date: 30/09/2021, Last updated: 12/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Relamorelin (updated)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-002323-PIP02-19, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Age-appropriate oral dosage form, Solution for injection
Decision date: 09/09/2020, Last updated: 12/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Natpar, Recombinant parathyroid hormone (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001526-PIP01-13-M05, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 08/09/2021, Last updated: 12/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Mysimba, bupropion hydrochloride, naltrexone hydrochloride (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001373-PIP01-12-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Prolonged-release tablet
Decision date: 08/09/2021, Last updated: 12/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Tolvaptan (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001231-PIP02-13-M08, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Oral suspension
Decision date: 08/09/2021, Last updated: 12/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Evarrest, human fibrinogen, human thrombin (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001149-PIP01-11-M07, Route(s) of administration: Epilesional use, Pharmaceutical form(s): Solution for sealant, Sealant matrix
Decision date: 08/09/2021, Last updated: 12/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Kyntheum, brodalumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Dermatology
PIP number: EMEA-001089-PIP02-13-M02, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 08/09/2021, Last updated: 12/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Rubidium (82Rb) chloride (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Diagnostic
PIP number: EMEA-000882-PIP03-11-M05, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Radionuclide generator
Decision date: 08/09/2021, Last updated: 12/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Bosulif, Bosutinib (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-000727-PIP01-09-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Film-coated tablet
Decision date: 08/09/2021, Last updated: 12/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Amikacin sulfate (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000525-PIP01-08-M07, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Nebuliser suspension
Decision date: 08/09/2021, Last updated: 12/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Cerdelga, Eliglustat (tartrate) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-000461-PIP02-11-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 08/09/2021, Last updated: 12/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): vaborbactam (updated)
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-001740-PIP01-14, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 22/10/2015, Last updated: 11/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): N-hydroxy-5-methylfuran-2-sulfonamide (BMS-986231) (updated)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002378-PIP01-18, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion, Age-appropriate dosage form for parenteral use
Decision date: 22/03/2019, Last updated: 09/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Olumiant, baricitinib (updated)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-001220-PIP05-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Age-appropriate oral formulation
Decision date: 18/03/2020, Last updated: 09/01/2023, Compliance check: X