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2299 results
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Opinion/decision on a Paediatric investigation plan (PIP): idecabtagene vicleucel (updated)
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): Deucravacitinib (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Dermatology
PIP number: EMEA-002350-PIP01-18-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form
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): Zeposia, Ozanimod (hydrochloride) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001710-PIP04-17-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Age-appropriate oral liquid dosage form
Decision date: 18/02/2021, Last updated: 08/10/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): ponesimod (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology; Other
PIP number: EMEA-000798-PIP01-09-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 18/02/2021, Last updated: 08/10/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Lartruvo, Olaratumab (updated)
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): Kesimpta, ofatumumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-002397-PIP01-18-M01, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 29/01/2021, Last updated: 06/10/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Xofluza, Baloxavir marboxil (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002440-PIP01-18-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Granules for oral suspension
Decision date: 29/01/2021, Last updated: 06/10/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain, A/H3N2-like strain, B-like strain (Victoria lineage) and B-like strain (Yamagata lineage) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-002359-PIP01-18-M02, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Syrup
Decision date: 18/01/2021, Last updated: 06/10/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): avibactam, Aztreonam (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002283-PIP01-17-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 29/01/2021, Last updated: 06/10/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): lasmiditan (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-002166-PIP01-17-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Orodispersible tablet
Decision date: 29/01/2021, Last updated: 06/10/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Epidyolex, Cannabidiol (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-001964-PIP01-16-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral solution
Decision date: 29/01/2021, Last updated: 06/10/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): 3-[[5-chloro-1-[3-(methylsulfonyl)propyl]-1H-indol-2-yl]methyl]-1-(2,2,2-trifluoroethyl)-1,3-dihydro-3-[[5-chloro-1-[3-(methylsulfonyl)propyl]-1H-indol-2-yl]methyl]-1-(2,2,2-trifluoroethyl)-1,3-dihydro-2H-imidazo[4,5-c]pyridine-2-one (JNJ-53718678) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001838-PIP01-15-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Powder and solvent for oral suspension
Decision date: 27/01/2021, Last updated: 06/10/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Artobend, In vitro expanded autologous human articular chondrocytes (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001823-PIP01-15-M02, Route(s) of administration: Intra-articular use, Pharmaceutical form(s): Implantation matrix
Decision date: 27/01/2021, Last updated: 06/10/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Skyrizi, Risankizumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-001776-PIP02-17-M01, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection, Age-appropriate pharmaceutical form
Decision date: 27/01/2021, Last updated: 06/10/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Biktarvy, bictegravir, emtricitabine, tenofovir alafenamide (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001766-PIP01-15-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral formulation, Film-coated tablet
Decision date: 27/01/2021, Last updated: 06/10/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Zynteglo, betibeglogene autotemcel (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001665-PIP01-14-M04, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for infusion
Decision date: 15/01/2021, Last updated: 06/10/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): VeraSeal, human fibrinogen, human thrombin (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001598-PIP01-13-M03, Route(s) of administration: Epilesional use, Pharmaceutical form(s): Solution for sealant
Decision date: 27/01/2021, Last updated: 06/10/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Descovy, emtricitabine, tenofovir alafenamide (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001577-PIP02-14-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral formulation, Film-coated tablet
Decision date: 27/01/2021, Last updated: 06/10/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Alofisel, darvadstrocel (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001561-PIP01-13-M02, Route(s) of administration: Other use, Pharmaceutical form(s): Suspension for injection
Decision date: 27/01/2021, Last updated: 06/10/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Reblozyl, Luspatercept (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001521-PIP01-13-M05, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 27/01/2021, Last updated: 06/10/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Xalkori, crizotinib (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001493-PIP03-18-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Age-appropriate oral dosage form
Decision date: 27/01/2021, Last updated: 05/10/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Cyclic pyranopterin monophosphate (fosdenopterin) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001491-PIP01-13-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 27/01/2021, Last updated: 05/10/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): daprodustat (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology; Uro-nephrology
PIP number: EMEA-001452-PIP01-13-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Dispersible tablet, Tablet
Decision date: 27/01/2021, Last updated: 05/10/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Zavicefta, Ceftazidime, avibactam (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001313-PIP01-12-M10, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 27/01/2021, Last updated: 29/09/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Rezolsta, darunavir, cobicistat (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001280-PIP01-12-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Dispersible tablet
Decision date: 27/01/2021, Last updated: 29/09/2021, Compliance check: X