Medicines

Last updated ≥ 19/08/2021 - 00:00 Remove ≥ 19/08/2021 - 00:00 filter

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Opinion/decision on a Paediatric investigation plan (PIP): Veklury, remdesivir

Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Infectious diseases
PIP number: EMEA-002826-PIP01-20-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion, Powder for concentrate for solution for infusion
Decision date: 09/08/2021, Last updated: 19/08/2021, Compliance check: X

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Opinion/decision on a Paediatric investigation plan (PIP): Imdevimab

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-002965-PIP01-21, Route(s) of administration: Subcutaneous use, Intravenous use, Pharmaceutical form(s): Solution for injection, Concentrate for solution for infusion
Decision date: 16/08/2021, Last updated: 19/08/2021, Compliance check: X

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Opinion/decision on a Paediatric investigation plan (PIP): Casirivimab

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-002964-PIP01-21, Route(s) of administration: Subcutaneous use, Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion, Solution for injection
Decision date: 16/08/2021, Last updated: 19/08/2021, Compliance check: X

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Opinion/decision on a Paediatric investigation plan (PIP): Molnupiravir

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-002940-PIP01-20, Route(s) of administration: Oral use, Gastric use, Pharmaceutical form(s): Capsule, hard, Age-appropriate dosage form, other
Decision date: 12/08/2021, Last updated: 19/08/2021, Compliance check: X

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Opinion/decision on a Paediatric investigation plan (PIP): Sotrovimab

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-002899-PIP01-20, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 17/06/2021, Last updated: 19/08/2021, Compliance check: X

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Opinion/decision on a Paediatric investigation plan (PIP): RoActemra, tocilizumab

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-000309-PIP07-21, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 27/07/2021, Last updated: 19/08/2021, Compliance check: X

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Opinion/decision on a Paediatric investigation plan (PIP): Forxiga, dapagliflozin

Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Infectious diseases
PIP number: EMEA-000694-PIP05-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 01/12/2020, Last updated: 19/08/2021, Compliance check: X