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29 results
Medicine
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Paediatric investigation plans Remove Paediatric investigation plans filter
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PIP decision type
W: decision granting a waiver in all age groups for all conditions or indications Remove W: decision granting a waiver in all age groups for all conditions or indications filter
RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s) Remove RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s) filter
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Opinion/decision on a Paediatric investigation plan (PIP): Darzalex, Daratumumab
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002152-PIP03-19, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Concentrate for solution for infusion, Solution for injection
Decision date: 18/03/2020, Last updated: 28/07/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Ibrance, palbociclib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002146-PIP02-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Age-appropriate oral dosage form, Tablet
Decision date: 03/01/2019, Last updated: 12/04/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Tysabri, natalizumab
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Neurology
PIP number: EMEA-001095-PIP03-19, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection in pre-filled syringe
Decision date: 18/03/2020, Last updated: 28/07/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Adcetris, Brentuximab vedotin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-000980-PIP04-18, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 08/10/2018, Last updated: 11/01/2019, Compliance check: X