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37 results

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Opinion/decision on a Paediatric investigation plan (PIP): Nerlynx, neratinib

Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002783-PIP01-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 15/07/2020, Last updated: 16/06/2021, Compliance check: X
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Opinion/decision on a Paediatric investigation plan (PIP): Gazyvaro, Obinutuzumab

Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-001207-PIP03-20, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 22/12/2020, Last updated: 17/09/2021, Compliance check: X
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Opinion/decision on a Paediatric investigation plan (PIP): Kevzara, sarilumab

Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-001045-PIP02-18, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 08/10/2018, Last updated: 11/01/2019, Compliance check: X
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Opinion/decision on a Paediatric investigation plan (PIP): Kevzara, sarilumab

Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-001045-PIP04-18, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 07/12/2018, Last updated: 20/02/2019, Compliance check: X
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Opinion/decision on a Paediatric investigation plan (PIP): Dupixent, dupilumab

Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Dermatology
PIP number: EMEA-001501-PIP05-20, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 12/08/2020, Last updated: 18/06/2021, Compliance check: X
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Opinion/decision on a Paediatric investigation plan (PIP): Dupixent, dupilumab

Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oto-rhino-laryngology
PIP number: EMEA-001501-PIP08-20, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 17/03/2021, Last updated: 15/11/2021, Compliance check: X
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Opinion/decision on a Paediatric investigation plan (PIP): Fasenra, benralizumab

Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Dermatology
PIP number: EMEA-001214-PIP06-20, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Age-appropriate dosage form for parenteral use, Solution for injection
Decision date: 14/08/2020, Last updated: 18/06/2021, Compliance check: X
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Opinion/decision on a Paediatric investigation plan (PIP): Rubraca, rucaparib camsylate

Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002760-PIP01-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 22/06/2020, Last updated: 09/03/2021, Compliance check: X
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Opinion/decision on a Paediatric investigation plan (PIP): Kyprolis, carfilzomib

Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001806-PIP03-18, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 15/05/2019, Last updated: 29/10/2019, Compliance check: X
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Opinion/decision on a Paediatric investigation plan (PIP): Alecensa, Alectinib

Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002431-PIP01-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 07/12/2018, Last updated: 13/02/2019, 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
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Opinion/decision on a Paediatric investigation plan (PIP): Zejula, Niraparib

Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002268-PIP03-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 15/05/2019, Last updated: 29/10/2019, Compliance check: X