Displaying 161 - 180 of 933
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-101093-PIP02-23
  • satralizumab
  • Treatment for thyroid eye disease (TED)
  • Enspryng
  • Enspryng
  • Enspryng
  • Neurology
  • Ophthamology
W: decision granting a waiver in all age groups for the listed condition(s). No 24/06/2024
MHRA-100601-PIP01-22-M03 (update)
  • elasomeran
  • imelasomeran
  • DAVESOMERAN
  • ANDUSOMERAN
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Spikevax
  • Spikevax bivalent Original/Omicron BA.1
  • Spikevax bivalent Original/Omicron BA.4-5
  • Spikevax
  • Spikevax
  • Spikevax bivalent Original/Omicron BA.1
  • Spikevax
  • Spikevax bivalent Original/Omicron BA.1
  • Spikevax bivalent Original/Omicron BA.4-5
  • Spikevax bivalent Original/Omicron BA.1
  • Spikevax bivalent Original/Omicron BA.1
  • Spikevax bivalent Original/Omicron BA.4-5
  • Spikevax bivalent Original/Omicron BA.4-5
  • Spikevax XBB.1.5
  • Spikevax XBB.1.5
  • Spikevax XBB.1.5
  • Spikevax XBB.1.5
  • Spikevax XBB.1.5
  • Spikevax XBB.1.5
  • Spikevax XBB1.5
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No 01/05/2024
MHRA-100564-PIP01-22-M03 (update)
  • TEDIZOLID PHOSPHATE
  • Treatment of acute bacterial skin and skin structure infections
  • Sivextro
  • Sivextro
  • Sivextro
  • Sivextro
  • Sivextro
  • Sivextro
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 01/05/2024
MHRA-101304-PIP01-23-M01 (update)
  • FILGOTINIB MALEATE
  • Treatment of ulcerative colitis
  • Jyseleca
  • Jyseleca
  • Jyseleca
  • Jyseleca
  • Jyseleca
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 01/05/2024
MHRA-101249-PIP01-23-M01 (update)
  • Tovorafenib
  • Treatment of paediatric low grade glioma
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 01/05/2024
MHRA-100197-PIP01-21-M02 (update)
  • Ebola Zaire Vaccine (rVSV∆G-ZEBOV-GP, live)
  • Prevention of Ebola disease
  • ERVEBO
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No 01/05/2024
MHRA-100089-PIP01-21-M02 (update)
  • DUPILUMAB
  • Treatment of eosinophilic oesophagitis
  • Dupixent
  • Dupixent
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 30/04/2024
MHRA-100079-PIP01-21-M03 (update)
  • GILTERITINIB FUMARATE
  • Treatment of acute myeloid leukaemia (AML)
  • Xospata
  • Xospata
  • Haematology-Hemostaseology
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-100614-PIP01-22-M02 (update)
  • VONICOG ALFA
  • Treatment of von Willebrand Disease
  • veyvondi
  • Vonvendi
  • veyvondi
  • veyvondi
  • Vonvendi
  • veyvondi
  • Vonvendi
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-101162-PIP01-23-M01 (update)
  • LETERMOVIR
  • Prevention of cytomegalovirus infection
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PRVEYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • tablet
  • PREVYMIS
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted 30/04/2024
MHRA-100811-PIP01-22-M02 (update)
  • Vamorolone
  • Treatment of Duchenne muscular dystrophy
  • AGAMREE
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-100646-PIP01-22-M02 (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 30/04/2024
MHRA-100372-PIP01-21-M01 (update)
  • concizumab
  • Treatment of congenital haemophilia A
  • Treatment of congenital haemophilia B
  • Alhemo
  • Alhemo
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-100164-PIP01-21-M03 (update)
  • Nirmatrelvir
  • RITONAVIR
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Paxlovid
  • Paxlovid
  • Paxlovid
  • Paxlovid
  • Paxlovid
  • Paxlovid
  • Paxlovid
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-100143-PIP01-21-M02 (update)
  • TENOFOVIR ALAFENAMIDE FUMARATE
  • Treatment of chronic viral hepatitis B
  • Vemlidy
  • Vemlidy
  • Vemlidy
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-100779-PIP01-22-M02 (update)
  • GUSELKUMAB
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and juvenile idiopathic arthritis)
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-101262-PIP01-23-M01 (update)
  • DIENOGEST
  • ETHINYLESTRADIOL
  • Prevention of pregnancy
  • Not available at present
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-100284-PIP01-21-M02 (update)
  • MEXILETINE HYDROCHLORIDE
  • Treatment of myotonic disorders
  • Namuscla
  • Namuscla
  • Other: Muscle disorders
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-100807-PIP01-22-M02 (update)
  • RIMEGEPANT SULFATE
  • Treatment of migraine headaches
  • Vydura
  • Vydura
  • Vydura
  • Vydura
  • Vydura
  • Nurtec ODT
  • Nurtec ODT
  • Nurtec ODT
  • Nurtec ODT
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-100695-PIP01-22-M04 (update)
  • Etranacogene dezaparvovec
  • Treatment of haemophilia B
  • Hemgenix
  • Hemgenix
  • Hemgenix
  • Hemgenix
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024