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37 results
PIP decision type
RPM: decision refers to a refusal on the application for modification of an agreed PIP Remove RPM: decision refers to a refusal on the application for modification of an agreed PIP filter
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
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Opinion/decision on a Paediatric investigation plan (PIP): Oxervate, Cenegermin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Ophthalmology
PIP number: EMEA-001729-PIP02-18, Route(s) of administration: Ocular use, Pharmaceutical form(s): Eye drops, solution
Decision date: 17/04/2019, Last updated: 25/06/2019, 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): Verzenios, abemaciclib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002342-PIP03-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 12/06/2019, Last updated: 07/11/2019, Compliance check: X -
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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: Dermatology
PIP number: EMEA-001501-PIP06-20, Route(s) of administration: Subcutaneous 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): 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): 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): 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