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126 results
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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): Reblozyl, Luspatercept
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001521-PIP01-13-M06, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 13/05/2022, Last updated: 12/05/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Bylvay, Odevixibat
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-002054-PIP01-16-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 13/05/2022, Last updated: 12/05/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Palynziq, Pegvaliase
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-001951-PIP01-16-M02, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution 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): Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron), Dinutuximab beta
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001314-PIP01-12-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion, Concentrate for solution for infusion, Powder and solvent for solution for injection, Powder for solution for infusion
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): Holoclar, Ex vivo expanded autologous human corneal epithelium cells containing stem cells
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Ophthalmology
PIP number: EMEA-001082-PIP02-11-M03, Route(s) of administration: Ophthalmic use, Pharmaceutical form(s): Living tissue equivalent
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): Yescarta, Axicabtagene ciloleucel
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002010-PIP01-16-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for infusion
Decision date: 13/04/2022, Last updated: 19/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Nulibry, Fosdenopterin (ORGN001)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001491-PIP01-13-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 13/04/2022, Last updated: 19/04/2023, Compliance check: V, 15/10/2021 -
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Opinion/decision on a Paediatric investigation plan (PIP): Galafold, Migalastat hydrochloride
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-001194-PIP01-11-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Oral solution
Decision date: 13/04/2022, Last updated: 19/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Iclusig, Ponatinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001186-PIP01-11-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Capsule, hard, Age-appropriate formulation
Decision date: 13/04/2022, Last updated: 19/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Arikayce liposomal, Amikacin sulfate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000525-PIP01-08-M08, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Nebuliser dispersion
Decision date: 13/04/2022, Last updated: 17/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Cystadrops, Cysteamine hydrochloride
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Ophthalmology
PIP number: EMEA-000322-PIP01-08-M06, Route(s) of administration: Ocular use, Pharmaceutical form(s): Eye drops, solution
Decision date: 03/02/2022, Last updated: 14/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Mylotarg, gemtuzumab ozogamicin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001733-PIP02-15-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 31/01/2022, Last updated: 14/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Pyrukynd, Mitapivat
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-002684-PIP01-19-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form
Decision date: 31/01/2022, Last updated: 12/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Ayvakyt, Avapritinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002358-PIP02-18-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form
Decision date: 31/01/2022, Last updated: 12/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Zolgensma, Onasemnogene abeparvovec
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-002168-PIP01-17-M04, Route(s) of administration: Intravenous use, Intrathecal use, Pharmaceutical form(s): Solution for injection/infusion
Decision date: 31/01/2022, Last updated: 12/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Cresemba, Isavuconazonium sulfate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001301-PIP02-12-M04, Route(s) of administration: Intravenous use, Oral use, Pharmaceutical form(s): Powder for solution for infusion, Capsule, hard
Decision date: 03/12/2021, Last updated: 28/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Idefirix, Imlifidase
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-002183-PIP01-17-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 11/03/2022, Last updated: 23/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Opsumit, Macitentan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001032-PIP01-10-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Dispersible tablet, Film-coated tablet
Decision date: 03/12/2021, Last updated: 16/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Revestive, teduglutide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-000482-PIP01-08-M06, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 01/12/2020, Last updated: 10/03/2023, Compliance check: V, 26/03/2021 -
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Opinion/decision on a Paediatric investigation plan (PIP): Idelvion, albutrepenonacog alfa
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001107-PIP01-10-M04, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for infusion, Powder and solvent for solution for injection
Decision date: 29/01/2020, Last updated: 10/03/2023, Compliance check: X, 21/01/2022 -
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Opinion/decision on a Paediatric investigation plan (PIP): Lamzede, velmanase alfa
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-001056-PIP02-12-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 23/10/2020, Last updated: 10/03/2023, Compliance check: V, 23/04/2021 -
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Opinion/decision on a Paediatric investigation plan (PIP): Adcetris, Brentuximab vedotin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-000980-PIP01-10-M07, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 28/01/2021, Last updated: 10/03/2023, Compliance check: V, 25/06/2021 -
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Opinion/decision on a Paediatric investigation plan (PIP): Epclusa, Sofosbuvir, velpatasvir
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001646-PIP01-14-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral formulation
Decision date: 18/05/2018, Last updated: 09/03/2023, Compliance check: V, 26/02/2021 -
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Opinion/decision on a Paediatric investigation plan (PIP): Evrysdi, Risdiplam (RO7034067)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-002070-PIP01-16-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Powder for oral solution
Decision date: 26/11/2021, Last updated: 13/02/2023, Compliance check: X