Displaying 61 - 80 of 137
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
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-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-100164-PIP01-21
  • (1R,2S,5S)-N-((1S)-1-Cyano-2-((3S)-2-oxopyrrolidin-3-yl)ethyl)-3-((2S)-3,3-dimethyl-2-(2,2,2-trifluoroacetamido)butanoyl)-6,6-dimethyl-3-azabicyclo[3.1.0]hexane-2-carboxamide
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Not available at present
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) 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-100163-PIP01-21
  • Vupanorsen (PF-07285557)
  • Treatment of Hypertriglyceridemia
  • Prevention of cardiovascular events
  • Not available at present
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No 18/03/2022
MHRA-100157-PIP01-21-M01 (update)
  • EXENATIDE
  • Type 2 diabetes mellitus
  • Byetta
  • Bydureon
  • Bydureon BCise
  • Byetta
  • Byetta
  • Bydureon
  • Bydureon
  • Byetta
  • Bydureon
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted 18/03/2022
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-100155-PIP01-21
  • efgartigimod alfa
  • Treatment of Chronic Inflammatory Demyelinating Polyneuropathy
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No 18/03/2022
MHRA-100147-PIP01-21-M01 (update)
  • OSELTAMIVIR PHOSPHATE
  • Treatment and prevention of influenza
  • Tamiflu
  • Tamiflu
  • Tamiflu
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 18/03/2022
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-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-100107-PIP01-21
  • 1-(3-methylbutanoyl)-l-aspartyl-l-threonyl-l-histidyl-l-phenylalanyl-l-prolyl-(l-cystinyl-l-isoleucyl-[(n6-(s)-4-carboxy-4-palmitamidobutanoyl)-l-lysinyl]-l-phenylalanyl-l-glutamyl-l-prolyl-l-arginyl-l-serinyl-l-lysinyl-l-glycinyl-l-cystinyl)-l-lysinamide, disulfide, acetate
  • Treatment of polycythaemia vera
  • Haematology-Hemostaseology
W: decision granting a waiver in all age groups for the listed condition(s). 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-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-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-100112-PIP01-21
  • savolitinib
  • Treatment of renal neoplasms
  • Not available
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 18/03/2022
MHRA-100086-PIP01-21-M01 (update)
  • UPADACITINIB
  • Treatment of atopic dermatitis
  • Rinvoq
  • Immunology -Rheumatology-Transplantation
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 18/03/2022
MHRA-100093-PIP01-21-M01 (update)
  • UPADACITINIB
  • Treatment of chronic idiopathic arthritis
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 18/03/2022
MHRA-100078-PIP01-21-M01 (update)
  • AZTREONAM
  • AVIBACTAM
  • Treatment of infections caused by aerobic gram-negative bacteria
  • Not available at present
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 18/03/2022
MHRA-100072-PIP01-21-M01 (update)
  • COVID-19 Vaccine (ChAdOx1-S [recombinant])
  • Prevention of coronavirus disease 2019 (COVID-19)
  • COVID-19 Vaccine AstraZeneca
  • COVID-19 Vaccine AstraZeneca
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No 18/03/2022