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1081 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): Momelotinib (updated)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-001656-PIP02-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 17/06/2019, Last updated: 28/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Sotrastaurin acetate (updated)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000093-PIP02-10, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate dosage form, other
Decision date: 26/01/2011, Last updated: 15/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Chloroprocaine hydrochloride (updated)
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Anaesthesiology
PIP number: EMEA-000639-PIP03-16-M02, Route(s) of administration: Perineural use, Pharmaceutical form(s): Solution for injection
Decision date: 11/08/2022, Last updated: 13/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Rimegepant
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Neurology
PIP number: EMEA-002812-PIP01-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Orodispersable Tablets
Decision date: 12/08/2020, Last updated: 01/08/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Mircera, Methoxy polyethylene glycol-epoetin beta
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-000172-PIP01-07-M03, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 31/10/2017, Last updated: 30/06/2023, Compliance check: V, 20/05/2022 -
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Opinion/decision on a Paediatric investigation plan (PIP): IMG-2789
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-002752-PIP01-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 16/06/2020, Last updated: 14/06/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Zynteglo, betibeglogene autotemcel
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001665-PIP01-14-M06, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for infusion
Decision date: 13/05/2022, Last updated: 16/05/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Modified allergen extract of birch pollen
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000932-PIP01-10-M02, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Suspension for injection
Decision date: 11/03/2022, Last updated: 19/04/2023, 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: 28/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Dermatophagoides pteronyssinus, Dermatophagoides farinae
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001014-PIP01-10-M01, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Coated tablet
Decision date: 22/03/2019, Last updated: 13/12/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Chemically modified extract of grass pollen from Holcus lanatus, Phleum pratense and Poa pratensis
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001016-PIP01-10-M01, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Coated tablet
Decision date: 22/03/2019, Last updated: 13/12/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): birch pollen, alder pollen
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001012-PIP01-10-M01, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Coated tablet
Decision date: 22/03/2019, Last updated: 13/12/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Recombinant porcine factor VIII, B-domain deleted
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-000753-PIP01-11, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for injection, Powder and solvent for solution for injection
Decision date: 24/02/2012, Last updated: 10/10/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): In vitro expanded autologous human articular chondrocytes
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Other
PIP number: EMEA-002217-PIP01-17-M02, Route(s) of administration: Intraarticular use, Pharmaceutical form(s): Implant
Decision date: 12/08/2021, Last updated: 01/09/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Elafibranor
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001857-PIP02-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 12/08/2020, Last updated: 10/08/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Tislelizumab
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002480-PIP01-18, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 17/04/2019, Last updated: 27/06/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Trelegy Ellipta, fluticasone furoate, umeclidinium bromide, vilanterol trifenatate
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-002153-PIP01-17-M01, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Inhalation powder, pre-dispensed
Decision date: 14/02/2020, Last updated: 10/12/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): octenidine dihydrochloride
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Neonatology-Paediatric Intensive Care
PIP number: EMEA-001384-PIP01-12, Route(s) of administration: Cutaneous use, Pharmaceutical form(s): Cutaneous solution
Decision date: 21/12/2016, Last updated: 29/11/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Reagila, Cariprazine (hydrochloride)
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Psychiatry
PIP number: EMEA-001652-PIP01-14-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 17/03/2021, Last updated: 26/11/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): idecabtagene vicleucel
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002369-PIP01-18-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for injection
Decision date: 19/02/2021, Last updated: 08/10/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Lartruvo, Olaratumab
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-001760-PIP01-15-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 22/03/2019, Last updated: 08/10/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): (1R,2R,3S,4S,5R,6S)-cyclohexane-1,2,3,4,5,6-hexayl-hexakis (dihydrogen phosphate)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Other
PIP number: EMEA-002854-PIP01-20, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 01/12/2020, Last updated: 22/09/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Linerixibat
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-002800-PIP01-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 09/09/2020, Last updated: 01/07/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Anti-neonatal Fc receptor human monoclonal antibody
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Other
PIP number: EMEA-002559-PIP01-19, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Concentrate for solution for infusion, Solution for injection
Decision date: 16/08/2019, Last updated: 01/07/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Viekirax, Ombitasvir, paritaprevir, ritonavir
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Infectious diseases
PIP number: EMEA-001440-PIP01-13-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Age-appropriate oral solid dosage form
Decision date: 12/08/2020, Last updated: 30/06/2021, Compliance check: X