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Displaying 401 - 420 of 783
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-101069-PIP01-23
  • resminostat mesilate
  • Treatment of cutaneous T-cell lymphoma
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101172-PIP01-23
  • Disitamab vedotin
  • Treatment of solid tumours including central nervous system malignancies
  • Aidixi
  • Aidixi
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101169-PIP01-23
  • vibostolimab
  • PEMBROLIZUMAB
  • Treatment of melanoma
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101235-PIP01-23
  • Humanised monoclonal antibody derivative against fibroblast growth factor receptor 3
  • Treatment of achondroplasia
  • Endocrinology-Gynaecology-Fertility-metabolism
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101215-PIP01-23
  • Rocatinlimab
  • Treatment of prurigo nodularis
  • Dermatology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101298-PIP01-23
  • Ulviprubart
  • Treatment of inclusion body myositis
  • Not available at present
  • Immunology -Rheumatology-Transplantation
  • Other: Musculoskeletal disorders
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101277-PIP01-23
  • LIVE ATTENUATED MEASLES VIRUS (SCHWARZ STRAIN)
  • LIVE ATTEN'D MUMPS VIRUS (RIT 4385 DERIVED FROM JERYL LYNN)
  • LIVE ATTENUATED RUBELLA (WISTAR RA 27/3 STRAIN)
  • Varicella virus Oka strain (live, attenuated)
  • Prevention of measles, mumps, rubella and varicella
  • Vaccines
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101156-PIP01-23
  • Cagrilintide
  • SEMAGLUTIDE
  • Type 2 Diabetes mellitus
  • Not available at present
  • Endocrinology-Gynaecology-Fertility-metabolism
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101265-PIP01-23
  • efgartigimod alfa
  • Treatment of thyroid eye disease
  • Vyvgar
  • Vyvgart
  • Vyvgart
  • Endocrinology-Gynaecology-Fertility-metabolism
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101226-PIP01-23
  • Volrustomig
  • Treatment of cervical cancer
  • Treatment of renal cell carcinoma
  • Treatment of lung cancer
  • Treatment of mesothelioma
  • Volrustomig
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101222-PIP01-23
  • SJP-0132
  • Treatment of Dry Eye Disease
  • Ophthamology
W: decision granting a waiver in all age groups for the listed condition(s). No
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
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
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
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
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
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
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
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
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