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167 results
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Opinion/decision on a Paediatric investigation plan (PIP): Xofluza, Baloxavir marboxil (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002440-PIP01-18-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Granules for oral suspension
Decision date: 03/12/2021, Last updated: 29/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Vitrakvi, Larotrectinib (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001971-PIP02-16-M04, Route(s) of administration: Gastric use, Oral use, Pharmaceutical form(s): Capsule, hard, Oral solution
Decision date: 03/12/2021, Last updated: 29/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Flucelvax Tetra, Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H1N1), Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H3N2), Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Yamagata lineage), Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Victoria lineage) [QIVc] (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-002068-PIP01-16-M04, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 03/12/2021, Last updated: 29/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Nuvaxovid, Severe acute respiratory syndrome coronavirus 2 recombinant spike protein nanoparticle vaccine/ matrix-M1 adjuvant (NVX-CoV2373) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-002941-PIP01-20-M01, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 03/12/2021, Last updated: 29/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Verquvo, Vericiguat (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001636-PIP01-14-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Age-appropriate oral liquid dosage form
Decision date: 03/12/2021, Last updated: 28/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Aimovig, erenumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-001664-PIP02-15-M05, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 03/12/2021, Last updated: 28/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Besponsa, inotuzumab ozogamicin (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology; Oncology
PIP number: EMEA-001429-PIP01-13-M04, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 03/12/2021, Last updated: 28/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Cresemba, Isavuconazonium sulfate (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001301-PIP02-12-M04, Route(s) of administration: Intravenous use, Oral use, Pharmaceutical form(s): Powder for solution for infusion, Capsule, hard
Decision date: 03/12/2021, Last updated: 28/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Vaxzevria (previously COVID-19 Vaccine AstraZeneca), COVID-19 vaccine (ChAdOx1-S [recombinant]) (AZD1222) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-002862-PIP01-20-M02, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 27/12/2021, Last updated: 28/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Breyanzi, Lisocabtagene maraleucel (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001995-PIP01-16-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for infusion
Decision date: 31/12/2021, Last updated: 28/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Bavencio, avelumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001849-PIP02-15-M04, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 31/12/2021, Last updated: 27/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Comirnaty, Tozinameran (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002861-PIP02-20-M03, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Concentrate for solution for injection
Decision date: 31/12/2021, Last updated: 27/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Idefirix, Imlifidase (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-002183-PIP01-17-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 11/03/2022, Last updated: 23/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Piqray, Alpelisib (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-002016-PIP03-19-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Granules
Decision date: 03/12/2021, Last updated: 22/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Adakveo, Crizanlizumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-002141-PIP01-17-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 09/12/2021, Last updated: 22/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Evkeeza, Evinacumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-002298-PIP01-17-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 03/12/2021, Last updated: 22/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Rinvoq, upadacitinib (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-001741-PIP01-14-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral solid dosage form, Age-appropriate oral liquid dosage form, Prolonged-release tablet
Decision date: 03/12/2021, Last updated: 21/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Dovprela (previously Pretomanid FGK), Pretomanid (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002115-PIP01-17-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Dispersible tablet, Tablet
Decision date: 03/12/2021, Last updated: 21/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Veyvondi, vonicog alfa (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001164-PIP01-11-M05, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
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): 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): 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): Lamzede, velmanase alfa (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-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 (updated)
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