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54 results
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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
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s) Remove P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s) filter
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Opinion/decision on a Paediatric investigation plan (PIP): Pyrukynd, Mitapivat
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-002684-PIP02-21, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral solid dosage form, Film-coated tablet
Decision date: 13/05/2022, Last updated: 10/05/2023, 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): Kyprolis, carfilzomib
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Haematology-Hemostaseology; Oncology
PIP number: EMEA-001806-PIP04-19, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 27/01/2021, Last updated: 29/09/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Nexpovio, Selinexor
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002387-PIP02-21, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 08/09/2021, Last updated: 10/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Trodelvy, Sacituzumab govitecan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002645-PIP03-21, Route(s) of administration: All routes of administration, Pharmaceutical form(s): All pharmaceutical forms
Decision date: 13/05/2022, Last updated: 11/05/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Lorviqua, Lorlatinib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002669-PIP02-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 15/01/2021, Last updated: 29/09/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Aspaveli, Pegcetacoplan
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Uro-nephrology
PIP number: EMEA-002600-PIP03-21, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for infusion
Decision date: 11/08/2022, Last updated: 28/08/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Mektovi, binimetinib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-001454-PIP05-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 29/01/2019, Last updated: 11/04/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Beovu, Brolucizumab
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Ophthalmology
PIP number: EMEA-002691-PIP02-20, Route(s) of administration: Intravitreal use, Pharmaceutical form(s): Solution for injection
Decision date: 23/10/2020, Last updated: 22/07/2021, 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): Ultomiris, ravulizumab
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Neurology
PIP number: EMEA-001943-PIP05-21, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 29/10/2021, Last updated: 13/02/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Ultomiris, ravulizumab
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Neurology
PIP number: EMEA-001943-PIP04-20, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 21/12/2021, Last updated: 06/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Aspaveli, Pegcetacoplan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Neurology
PIP number: EMEA-002600-PIP04-22, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 09/09/2022, Last updated: 28/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Bimervax, SARS-CoV-2 virus recombinant spike (S) protein receptor binding domain (RBD) fusion heterodimer – B.1.351-B.1.1.7 strains
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Infectious diseases; Vaccines
PIP number: EMEA-003191-PIP01-22, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Emulsion for injection
Decision date: 04/11/2022, Last updated: 12/10/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Tukysa, Tucatinib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002242-PIP02-21, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 11/03/2022, Last updated: 13/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Piqray, Alpelisib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002016-PIP04-20, Route(s) of administration: All routes of administration, Pharmaceutical form(s): All pharmaceutical forms
Decision date: 17/03/2021, Last updated: 05/11/2021, Compliance check: V, 20/09/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): Pemazyre, pemigatinib (new)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002370-PIP03-22, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 01/12/2022, Last updated: 10/11/2023, 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): Gazyvaro, Obinutuzumab (new)
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-001207-PIP06-22, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate and solvent for concentrate for solution for infusion
Last updated: 10/11/2023, Compliance check: X -
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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): Gavreto, pralsetinib
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-002575-PIP02-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 09/07/2021, Last updated: 22/07/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Gavreto, pralsetinib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002575-PIP03-21, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 29/10/2021, Last updated: 13/02/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Ozempic, semaglutide
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-001441-PIP05-20, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection in pre-filled pen
Decision date: 29/10/2021, Last updated: 10/02/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Takhzyro, lanadelumab
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Other
PIP number: EMEA-001864-PIP02-19, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 18/04/2020, Last updated: 03/03/2021, Compliance check: X