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Displaying 81 - 100 of 426
PIPS Search Results
PIP Number Active Substance Sort descending Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
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-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
MHRA-100276-PIP01-21-M02 (update)
  • BRODALUMAB
  • Treatment of psoriasis
  • Kyntheum
  • Lumicef
  • Siliq
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/08/2023
MHRA-100052-PIP01-21-M01 (update)
  • CASIRIVIMAB
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Ronapreve
  • Ronapreve
  • Ronapreve
  • Ronapreve
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 04/05/2022
MHRA-100052-PIP01-21-M02 (update)
  • CASIRIVIMAB
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Ronapreve
  • Ronapreve
  • Ronapreve
  • Ronapreve
  • Ronapreve
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100053-PIP01-21-M01 (update)
  • IMDEVIMAB
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Prevention of Coronavirus Disease 2019 (COVID-19)
  • Ronapreve
  • Ronapreve
  • Ronapreve
  • Ronapreve
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 04/05/2022
MHRA-100053-PIP01-21 -M02 (update)
  • IMDEVIMAB
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Prevention of Coronavirus Disease 2019 (COVID-19)
  • Ronapreve
  • Ronapreve
  • Ronapreve
  • Ronapreve
  • Ronapreve
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100254-PIP01-21-M01 (update)
  • epcoritamab
  • Treatment of mature B-cell malignancies
  • Not available at present
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100467-PIP01-22-M01 (update)
  • SEMAGLUTIDE
  • Treatment of obesity
  • Ozempic
  • Ozempic 0.25 mg, 0.5 mg, 1 mg
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100038-PIP01-21-M01 (update)
  • SARS CoV2 prefusion Spike delta TM (CoV2 preS dTM) protein, recombinant adjuvanted with AS03
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Vidprevtyn
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/05/2022
MHRA-100087-PIP01-21-M01 (update)
  • LACOSAMIDE
  • Treatment of generalised epilepsy and epileptic syndromes
  • VIMPAT
  • lacosamide
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • lacosamide
  • lacosamide
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/05/2022
MHRA-100087-PIP01-21-M02 (update)
  • LACOSAMIDE
  • Treatment of generalised epilepsy and epileptic syndromes.
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100099-PIP01-21-M01 (update)
  • BRIVARACETAM
  • Treatment of paediatric epilepsy syndromes
  • Treatment of neonatal seizures
  • Briviact
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/05/2022
MHRA-100099-PIP01-21-M02 (update)
  • BRIVARACETAM
  • Treatment of paediatric epilepsy syndromes
  • Treatment of neonatal seizures
  • Briviact (in Italy: Nubriveo)
  • Briviact
  • Briviact
  • Briviact
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/05/2022