Displaying 1 - 20 of 1135
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-100137-PIP01-21-M04 (update)
  • linaclotide
  • Treatment of functional constipation
  • Constella
  • Constella
  • Constella
  • Constella
  • Constella
  • Constella
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100209-PIP01-21-M03 (update)
  • survodutide
  • Treatment of obesity
  • Not available at present
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102483-PIP01-26
  • Efimosfermin alfa
  • Treatment of alcohol-related liver disease
  • Gastroenterology-Hepatology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100646-PIP01-22-M03 (update)
  • TOLVAPTAN
  • Treatment of dilutional hyponatraemia
  • Treatment of polycystic kidney disease
  • Samsca
  • Jinarc
  • Samsca
  • Jinarc
  • Uro-Nephrology
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100178-PIP01-21-M01 (update)
  • pariglasgene brecaparvovec (DTX401)
  • Treatment of glycogen storage disease type 1a (GSDIa)
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102236-PIP01-25
  • Enicepatide
  • Treatment of Type 2 Diabetes Mellitus
  • Endocrinology-Gynaecology-Fertility-metabolism
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100349-PIP01-26
  • Rezafungin acetate
  • Prevention of invasive fungal infections
  • Rezzayo
  • Rezzayo
  • Rezzayo
  • Rezzayo
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101097-PIP01-23-M02 (update)
  • Modified Vaccinia Ankara – Bavarian Nordic Live virus
  • Prevention of smallpox, mpox and diseases caused by vaccinia virus
  • Imvanex
  • Imvamune
  • Imvanex
  • Imvanex
  • Jynneos
  • Jynneos
  • Jynneos
  • Jynneos
  • IMVANEX (associated names: JYNNEOS, IMVAMUNE)
  • Infectious diseases
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100164-PIP01-21-M06 (update)
  • Nirmatrelvir
  • RITONAVIR
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Paxlovid
  • Paxlovid
  • Paxlovid
  • Paxlovid
  • Paxlovid
  • Paxlovid
  • Paxlovid
  • Paxlovid
  • Paxlovid
  • Paxlovid
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101091-PIP01-23-M01 (update)
  • Borrelia outer surface protein A (OspA) serotypes (ST1- 6) lipidated, fusion protein vaccine (VLA15 - PF07307405)
  • Prevention of Lyme disease
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102423-PIP01-26
  • elegrobart
  • Treatment of thyroid eye disease
  • Elegrobart
  • Endocrinology-Gynaecology-Fertility-metabolism
  • Ophthamology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101785-PIP01-25-M01 (update)
  • Repinatrabit
  • Treatment of hyperphenylalaninemia
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100999-PIP03-23
  • Ensitrelvir
  • Prevention of coronavirus disease 2019 (COVID-19).
  • Zokovea
  • Xocova
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted
MHRA-100469-PIP01-22-M02 (update)
  • delgocitinib
  • Treatment of chronic hand eczema
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-101723-PIP01-24-M01 (update)
  • USTEKINUMAB
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylarthritis and juvenile idiopathic arthritis).
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Selara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100222-PIP01-21-M03 (update)
  • romosozumab
  • Treatment of osteoporosis
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100062-PIP01-21-M01 (update)
  • VANZACAFTOR CALCIUM DIHYDRATE
  • TEZACAFTOR
  • DEUTIVACAFTOR
  • Treatment of Cystic Fibrosis
  • alyftrek
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-101174-PIP01-23-M01 (update)
  • LENACAPAVIR SODIUM
  • Lenacapavir
  • Prevention of human immunodeficiency virus (HIV-1) infection
  • Sunlenca
  • Yeytuo
  • Sunlenca
  • Yeytuo
  • Sunlenca
  • Yeytuo
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100507-PIP01-22-M03 (update)
  • BREXPIPRAZOLE
  • Treatment of schizophrenia
  • RXULTI
  • RXULTI
  • Psychiatry
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-102324-PIP01-26-M01 (update)
  • CABOZANTINIB
  • Treatment of malignant solid tumours
  • Cabometyx
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted