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Displaying 61 - 80 of 385
PIPS Search Results
PIP Number Active Substance Sort descending Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-100093-PIP01-21-M02 (update)
  • UPADACITINIB
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, spondyloarthritis and juvenile idiopathic arthritis)
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100093-PIP01-21-M03 (update)
  • UPADACITINIB
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, spondyloarthritis and juvenile idiopathic arthritis)
  • Rinvoq
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100084-PIP01-21-M01 (update)
  • MIDOSTAURIN
  • Treatment of acute myeloid leukaemia
  • Malignant mastocytosis
  • Mast cell leukaemia
  • Rydapt® 25 mg soft capsules
  • Rydapt® 25 mg soft capsules
  • Rydapt® 25 mg soft capsules
  • Rydapt® 25 mg soft capsules
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 18/03/2022
MHRA-100089-PIP01-21-M01 (update)
  • dupilumab
  • Treatment of eosinophilic oesophagitis
  • Dupixent
  • Dupixent
  • Dupixent
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 18/03/2022
MHRA-100090-PIP01-21-M01 (update)
  • DUPILUMAB
  • Treatment of atopic dermatitis
  • Dupixent
  • Dupixent
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 18/03/2022
MHRA-100586-PIP01-22-M01 (update)
  • DUPILUMAB
  • Treatment of asthma
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100586-PIP01-22-M02 (update)
  • DUPILUMAB
  • Treatment of asthma
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-100118-PIP01-21-M01 (update)
  • OCRELIZUMAB
  • Treatment of Multiple Sclerosis
  • Ocrevus
  • Ocrevus
  • Ocrevus
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 18/03/2022
MHRA-100118-PIP01-21-M02 (update)
  • OCRELIZUMAB
  • Treatment of Multiple Sclerosis
  • Ocrevus
  • Ocrevus
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100119-PIP01-21-M01 (update)
  • TEZACAFTOR
  • IVACAFTOR
  • Treatment of Cystic Fibrosis
  • Symkevi
  • Symkevi
  • Symkevi
  • Pneumology - Allergology
  • Other: Congenital, hereditary and neonatal diseases and abnormalities
PM: decision on the application for modification of an agreed paediatric investigation plan. No 18/03/2022
MHRA-100116-PIP01-21-M01 (update)
  • TEZACAFTOR
  • ELEXACAFTOR
  • IVACAFTOR
  • Treatment of Cystic Fibrosis
  • Kaftrio
  • Kaftrio
  • Trikafta
  • Kaftrio
  • Trikafta
  • Trikafta
  • Trikafta
  • Kaftrio
  • Pneumology - Allergology
  • Other: Congenital, hereditary and neonatal diseases and abnormalities
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/05/2022
MHRA-100116-PIP01-21-M02 (update)
  • IVACAFTOR
  • TEZACAFTOR
  • ELEXACAFTOR
  • Treatment of cystic fibrosis
  • Kaftrio
  • Trikafta
  • Trikafta
  • Trikafta
  • Trikafta
  • Trikafta
  • Trikafta
  • Trikafta
  • Kaftrio
  • Kaftrio
  • Trikafta
  • Trikafta
  • Trikafta
  • Trikafta
  • Kaftrio
  • Pneumology - Allergology
  • Other: Congenital, hereditary and neonatal diseases and abnormalities
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100156-PIP01-21-M01 (update)
  • FLUOCINOLONE ACETONIDE
  • Treatment of non-infectious uveitis
  • Secondary prevention of non-infectious uveitis
  • ILUVIEN 190 micrograms intravitreal implant in applicator
  • ILUVIEN 190 micrograms intravitreal implant in applicator
  • ILUVIEN 190 micrograms intravitreal implant in applicator
  • ILUVIEN 190 Mikrogramm intravitreales Implantat im Applikator
  • ILUVIEN 190 microgrammes, implant intravitréen avec applicateur
  • ILUVIEN 190 mikrogramů intravitreální implantát v aplikátoru
  • ILUVIEN
  • Iluvien 190 mikrogrammaa, implantaatti silmän lasiaiseen, asetin
  • ILUVIEN 190 microgrammes, implant intravitréen avec applicateur
  • ILUVIEN 190 Mikrogramm intravitreales Implantat im Applikator
  • ILUVIEN 190 microgrammi impianto intravitreale in applicatore
  • ILUVIEN 190 microgrammes, implant intravitréen avec applicateur
  • ILUVIEN 190 microgram, intravitreaal implant in applicator
  • Iluvien 190 mikrogram intravitrealt implantat i applikator
  • ILUVIEN, 190 mikrogramów, implant do ciałka szklistego w aplikatorze
  • ILUVIEN 190 microgramas implante intravítreo em aplicador
  • ILUVIEN 190 microgramos implante intravítreo en aplicador
  • Iluvien 190 mikrogram intravitrealt implantat i applikator
  • ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg
  • ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg
  • ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg
  • ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg
  • ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg
  • ILUVIEN fluocinolone acetonide 190 micrograms intravitreal implant in applicator
  • Ophthamology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 18/03/2022
MHRA-100168-PIP01-21-M01 (update)
  • Naloxegol (as naloxegol oxalate)
  • Treatment of opioid-induced constipation
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 18/03/2022
MHRA-100392-PIP01-21-M01 (update)
  • TOZINAMERAN
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Comirnaty
  • Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty 30 micrograms/dose concentrate for dispersio n for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 27/04/2022
MHRA-100391-PIP01-21-M01 (update)
  • TOZINAMERAN
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Comirnaty
  • Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty 30 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 27/04/2022
MHRA-100392-PIP01-21-M02 (update)
  • TOZINAMERAN
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Comirnaty
  • Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100392-PIP01-21-M03 (update)
  • TOZINAMERAN
  • TOZINAMERAN/ FAMTOZINAMERAN
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Comirnaty
  • Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty concentrate for dispersion for injection; COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty concentrate for dispersion for injection; COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty concentrate for dispersion for injection; COVID-19 mRNA Vaccine (nucleoside modified)
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100390-PIP01-21-M01 (update)
  • Highly purified single-stranded, 5'-capped mRNA encoding full length SARS-CoV2 spike protein (BNT162b2)
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty 30 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No 27/04/2022
MHRA-100276-PIP01-21-M01 (update)
  • BRODALUMAB
  • Treatment of psoriasis
  • brodalumab
  • Lumicef
  • Siliq
  • Kyntheum
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 04/05/2022