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Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine hydrochloride (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-001990-PIP01-16-M05, Route(s) of administration: Oral use, Gastric use, Pharmaceutical form(s): Oral solution
Decision date: 09/09/2022, Last updated: 18/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Piqray, Alpelisib (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-002016-PIP03-19-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Granules
Decision date: 30/09/2022, Last updated: 18/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Anti-CD7 mAb conjugated to ricin toxin A chain, Anti-CD3 mAb conjugated to ricin toxin A chain (updated)
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-002087-PIP01-16-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 09/09/2022, Last updated: 18/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Dovato, lamivudine, dolutegravir (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001940-PIP01-16-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Dispersible tablet, Dispersible tablet
Decision date: 09/09/2022, Last updated: 18/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Copanlisib (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001757-PIP02-15-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 09/09/2022, Last updated: 18/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Zeposia, Ozanimod (hydrochloride) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-001710-PIP02-14-M07, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Age-appropriate oral solid dosage form
Decision date: 09/09/2022, Last updated: 18/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Crysvita, Burosumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001659-PIP01-15-M06, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 30/09/2022, Last updated: 18/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Erdafitinib (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002042-PIP02-20-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate dosage form
Decision date: 10/06/2022, Last updated: 15/09/2023, 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): Sotrastaurin acetate (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000093-PIP01-07-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 04/07/2011, Last updated: 15/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Finerenone (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001623-PIP03-20-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate formulation
Decision date: 09/09/2022, Last updated: 15/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Cannabidiol, delta-9-tetrahydrocannabinol (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pain
PIP number: EMEA-000181-PIP02-13-M01, Route(s) of administration: Oromucosal use, Pharmaceutical form(s): Oromucosal spray
Decision date: 09/09/2022, Last updated: 14/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Stelara, Ustekinumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-000311-PIP04-13-M04, Route(s) of administration: Subcutaneous use, Intravenous use, Pharmaceutical form(s): Solution for injection/infusion, Concentrate for solution for infusion
Decision date: 09/09/2022, Last updated: 14/09/2023, Compliance check: X -
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