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Opinion/decision on a Paediatric investigation plan (PIP): Quizartinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001821-PIP01-15-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Powder for oral solution
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): Odevixibat
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-002054-PIP01-16-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Age-appropriate oral liquid dosage form
Decision date: 11/09/2020, Last updated: 02/07/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Cenicriviroc
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001999-PIP02-17-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral liquid dosage form, Film-coated 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): Trifarotene
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Dermatology
PIP number: EMEA-001492-PIP02-18, Route(s) of administration: Topical use, Pharmaceutical form(s): Cream
Decision date: 11/09/2020, Last updated: 20/03/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): pegvorhyaluronidase alpha
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-001883-PIP03-17, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 11/09/2020, Last updated: 20/03/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): fosmetpantotenate
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-002036-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Powder for oral suspension, Granules for oral suspension
Decision date: 11/09/2020, Last updated: 20/03/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): liposomal ciclosporin A (L-CsA)
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-002344-PIP02-18, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Powder for nebuliser solution
Decision date: 11/09/2020, Last updated: 23/03/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Tirzepatide
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-002360-PIP01-18, Route(s) of administration: Subcutaneous use,
Decision date: 10/09/2020, Last updated: 23/03/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Equine immunoglobulin F(ab')2 fragments targeting Shiga toxin
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Infectious diseases
PIP number: EMEA-002444-PIP02-18, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 10/09/2020, Last updated: 23/03/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): belantamab mafodotin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002468-PIP04-18, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 11/09/2020, Last updated: 19/02/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): levonorgestrel
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-002474-PIP02-18, Route(s) of administration: Vaginal use, Pharmaceutical form(s): Vaginal delivery system
Decision date: 10/09/2020, Last updated: 25/03/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Rosuvastatin, Ramipril
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002569-PIP04-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 11/09/2020, Last updated: 25/03/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Rosuvastatin, Ramipril
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002569-PIP04-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 11/09/2020, Last updated: 25/03/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Atropine (sulfate), Obidoxime (chloride)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Other
PIP number: EMEA-002570-PIP01-19, Route(s) of administration: Intramuscular use,
Decision date: 10/09/2020, Last updated: 25/03/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): zofenopril, nebivolol
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002593-PIP01-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 10/09/2020, Last updated: 25/03/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Infigratinib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002594-PIP01-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 10/09/2020, Last updated: 25/03/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Fexapotide (friflutate)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Uro-nephrology
PIP number: EMEA-002598-PIP01-19, Route(s) of administration: Intraprostatic use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 11/09/2020, Last updated: 25/03/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Botulinum toxin type A
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002628-PIP01-19, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 10/09/2020, Last updated: 25/03/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): hydrocortisone (hemisuccinate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neonatology-Paediactric Intensive care
PIP number: EMEA-002305-PIP01-17-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 09/09/2020, Last updated: 02/07/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): 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-PIP01-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral solid dosage form, Film-coated tablet
Decision date: 09/09/2020, Last updated: 16/02/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Lerodalcibep
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-002720-PIP01-19, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 09/09/2020, Last updated: 30/06/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Retifanlimab
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002798-PIP01-20, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection/infusion
Decision date: 09/09/2020, Last updated: 30/06/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Live attenuated poliovirus type 1, Live attenuated poliovirus type 3
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Vaccines
PIP number: EMEA-002799-PIP01-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral suspension for use in drinking water
Decision date: 09/09/2020, Last updated: 30/06/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Cluster of differentiation 40 (CD40) ligand antagonist comprising two identical Tn3 modules fused to human serum albumin, with each Tn3 module being an engineered form of the third fibronectin type III protein domain of human Tenascin C (VIB4920)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-002825-PIP01-20, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
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): rosuvastatin calcium, acetylsalicylic acid
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002831-PIP01-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 09/09/2020, Last updated: 01/07/2021, Compliance check: X