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Opinion/decision on a Paediatric investigation plan (PIP): Nulibry, Fosdenopterin (ORGN001)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001491-PIP01-13-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 13/04/2022, Last updated: 19/04/2023, Compliance check: V, 15/10/2021 -
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Opinion/decision on a Paediatric investigation plan (PIP): Halaven, Eribulin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001261-PIP01-11-M07, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection
Decision date: 06/12/2021, Last updated: 16/03/2023, Compliance check: V, 25/02/2022 -
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Opinion/decision on a Paediatric investigation plan (PIP): Tamiflu, Oseltamivir (phosphate)
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
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): Cosentyx, Secukinumab
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
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)
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
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology-Gynaecology-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
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
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
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
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)
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
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
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)
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
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 -
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Opinion/decision on a Paediatric investigation plan (PIP): Cotellic, Cobimetinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001425-PIP01-13-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral formulation
Decision date: 17/03/2021, Last updated: 10/03/2023, Compliance check: V, 25/06/2021 -
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Opinion/decision on a Paediatric investigation plan (PIP): Lamzede, velmanase alfa
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-001056-PIP02-12-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 23/10/2020, Last updated: 10/03/2023, Compliance check: V, 23/04/2021 -
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Opinion/decision on a Paediatric investigation plan (PIP): Iblias, octocog alfa
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001064-PIP01-10-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 16/03/2018, Last updated: 10/03/2023, Compliance check: V, 23/07/2021 -
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Opinion/decision on a Paediatric investigation plan (PIP): Tecfidera, dimethyl fumarate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000832-PIP01-10-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 15/05/2020, Last updated: 10/03/2023, Compliance check: V, 14/06/2021 -
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Opinion/decision on a Paediatric investigation plan (PIP): Trecondi, Treosulfan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation; Oncology
PIP number: EMEA-000883-PIP01-10-M05, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution
Decision date: 09/09/2020, Last updated: 10/03/2023, Compliance check: V, 25/03/2022 -
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Opinion/decision on a Paediatric investigation plan (PIP): Adcetris, Brentuximab vedotin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-000980-PIP01-10-M07, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 28/01/2021, Last updated: 10/03/2023, Compliance check: V, 25/06/2021 -
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Opinion/decision on a Paediatric investigation plan (PIP): Bydureon, exenatide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-000689-PIP01-09-M11, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection, Powder and solvent for prolonged-release suspension for injection, Solution for injection in pre-filled injector
Decision date: 18/02/2021, Last updated: 10/03/2023, Compliance check: V, 21/05/2021 -
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Opinion/decision on a Paediatric investigation plan (PIP): Alpivab, Peramivir
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001856-PIP02-16-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 07/07/2021, Last updated: 09/03/2023, Compliance check: V, 17/12/2021