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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): 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): Genvoya, elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001460-PIP01-13-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 13/11/2020, Last updated: 09/03/2023, Compliance check: V, 25/06/2021