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Opinion/decision on a Paediatric investigation plan (PIP): Moventig, Naloxegol (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001146-PIP01-11-M07, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Age-appropriate oral liquid dosage formulation
Decision date: 03/12/2021, Last updated: 16/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Evenity, Romosozumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001075-PIP04-15-M04, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 31/12/2021, Last updated: 16/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Opsumit, Macitentan (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001032-PIP01-10-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Dispersible tablet, Film-coated tablet
Decision date: 03/12/2021, Last updated: 16/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Jakavi, Ruxolitinib (phosphate) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-000901-PIP04-17-M02, Route(s) of administration: Oral use, Gastric use, Pharmaceutical form(s): Tablet, Age-appropriate oral solid dosage form
Decision date: 03/12/2021, Last updated: 15/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Fycompa, perampanel (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000467-PIP01-08-M15, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Oral suspension
Decision date: 03/12/2021, Last updated: 15/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Bilastine (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Ophthalmology
PIP number: EMEA-000347-PIP02-16-M03, Route(s) of administration: Ocular use, Pharmaceutical form(s): Eye drops, solution
Decision date: 03/12/2021, Last updated: 15/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Methoxyflurane (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pain
PIP number: EMEA-000334-PIP01-08-M10, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Inhalation vapour, liquid
Decision date: 03/12/2021, Last updated: 15/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Xydalba, dalbavancin hydrochloride (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000016-PIP01-07-M08, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 03/12/2021, Last updated: 14/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Loncastuximab tesirine (updated)
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-002665-PIP02-20, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 01/10/2021, Last updated: 14/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Tamiflu, Oseltamivir (phosphate) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000365-PIP01-08-M12, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Powder for oral suspension
Decision date: 25/06/2021, Last updated: 13/03/2023, Compliance check: V, 15/10/2021 -
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Opinion/decision on a Paediatric investigation plan (PIP): Brilique, ticagrelor (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases; Haematology-Hemostaseology
PIP number: EMEA-000480-PIP01-08-M14, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Orodispersible tablet, Tablet
Decision date: 09/04/2021, Last updated: 13/03/2023, Compliance check: V, 25/06/2021 -
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Opinion/decision on a Paediatric investigation plan (PIP): Eylea, aflibercept (updated)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Ophthalmology
PIP number: EMEA-000236-PIP05-18, Route(s) of administration: Intravitreal use, Pharmaceutical form(s): Solution for injection
Decision date: 04/04/2019, Last updated: 13/03/2023, Compliance check: V, 15/10/2021 -
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Opinion/decision on a Paediatric investigation plan (PIP): Cosentyx, Secukinumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000380-PIP01-08-M04, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder for solution for injection, Solution for injection
Decision date: 01/12/2017, Last updated: 13/03/2023, Compliance check: V, 20/04/2021 -
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Opinion/decision on a Paediatric investigation plan (PIP): Cosentyx, Secukinumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000380-PIP02-09-M04, Route(s) of administration: Subcutaneous use, Intravenous use, Pharmaceutical form(s): Powder for solution for injection or infusion, Solution for injection
Decision date: 07/12/2018, Last updated: 13/03/2023, Compliance check: V, 25/06/2021 -
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Opinion/decision on a Paediatric investigation plan (PIP): Tivicay, Dolutegravir (DTG) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000409-PIP01-08-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Age appropriate formulation for oral use, Film-coated tablet
Decision date: 09/07/2021, Last updated: 13/03/2023, Compliance check: V, 15/10/2021 -
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Opinion/decision on a Paediatric investigation plan (PIP): Elonva, corifollitropin alfa (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000306-PIP01-08-M04, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 17/04/2019, Last updated: 13/03/2023, Compliance check: V, 29/01/2021 -
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Opinion/decision on a Paediatric investigation plan (PIP): Afstyla, lonoctocog alfa (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001215-PIP01-11-M07, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 10/09/2019, Last updated: 10/03/2023, Compliance check: V, 10/09/2021 -
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Opinion/decision on a Paediatric investigation plan (PIP): cerliponase alfa (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-001362-PIP01-12-M03, Route(s) of administration: Intracerebral use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 05/09/2016, Last updated: 10/03/2023, Compliance check: V, 26/02/2021 -
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Opinion/decision on a Paediatric investigation plan (PIP): Turoctocog alfa pegol (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001174-PIP02-12-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 07/06/2017, Last updated: 10/03/2023, Compliance check: V, 23/07/2021 -
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Opinion/decision on a Paediatric investigation plan (PIP): Revestive, teduglutide (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-000482-PIP01-08-M06, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 01/12/2020, Last updated: 10/03/2023, Compliance check: V, 26/03/2021 -
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Opinion/decision on a Paediatric investigation plan (PIP): citric acid (as citric acid anhydrous), macrogol 4000, potassium chloride, simeticone, sodium chloride, sodium citrate, sodium sulfate (as sodium sulfate anhydrous) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001356-PIP02-12-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Powder for oral suspension
Decision date: 14/04/2021, Last updated: 10/03/2023, Compliance check: V, 17/12/2021 -
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Opinion/decision on a Paediatric investigation plan (PIP): Opdivo, nivolumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001407-PIP01-12-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 05/11/2020, Last updated: 10/03/2023, Compliance check: V, 21/01/2022 -
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Opinion/decision on a Paediatric investigation plan (PIP): Idelvion, albutrepenonacog alfa (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001107-PIP01-10-M04, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for infusion, Powder and solvent for solution for injection
Decision date: 29/01/2020, Last updated: 10/03/2023, Compliance check: X, 21/01/2022 -
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Opinion/decision on a Paediatric investigation plan (PIP): Human-cell-line recombinant human factor VIII (human-cl rhFVIII), Human Coagulation Factor VIII (rDNA) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001024-PIP01-10-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 06/01/2020, Last updated: 10/03/2023, Compliance check: V, 26/03/2021 -
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Opinion/decision on a Paediatric investigation plan (PIP): Zerbaxa, Ceftolozane, tazobactam (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001142-PIP01-11-M04, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 13/11/2020, Last updated: 10/03/2023, Compliance check: V, 25/06/2021