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7 results

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Opinion/decision on a Paediatric investigation plan (PIP): Ocaliva, Obeticholic acid

Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001304-PIP03-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral solid dosage form, Tablet
Decision date: 11/04/2018, Last updated: 25/07/2018, Compliance check: X
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Opinion/decision on a Paediatric investigation plan (PIP): Soliris, Eculizumab

Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000876-PIP06-15, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 28/07/2016, Last updated: 20/04/2018, Compliance check: X
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Opinion/decision on a Paediatric investigation plan (PIP): Obizur, susoctocog alfa

Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-000753-PIP02-16, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 19/12/2017, Last updated: 05/03/2018, Compliance check: X
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Opinion/decision on a Paediatric investigation plan (PIP): Soliris, Eculizumab

Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000876-PIP07-15, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 01/09/2016, Last updated: 27/10/2016, Compliance check: X
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Opinion/decision on a Paediatric investigation plan (PIP): ATryn, Antithrombin alfa

Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001154-PIP01-11, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 27/09/2011, Last updated: 18/10/2011, Compliance check: X
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Opinion/decision on a Paediatric investigation plan (PIP): Darzalex, Daratumumab

Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Oncology
PIP number: EMEA-002152-PIP01-17, Route(s) of administration: Subcutaneous use, Intravenous use, Pharmaceutical form(s): Solution for injection, Concentrate for solution for infusion
Decision date: 15/06/2018, Last updated: 27/11/2018, Compliance check: X
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Opinion/decision on a Paediatric investigation plan (PIP): Zejula, Niraparib (tosylate monohydrate)

Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Oncology
PIP number: EMEA-002268-PIP02-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Capsule, hard, Age-appropriate oral liquid dosage form
Decision date: 10/09/2020, Last updated: 23/03/2020, Compliance check: X