Displaying 1 - 20 of 959
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-102141-PIP01-25
  • Nanvuranlat
  • Treatment of biliary tract cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102060-PIP01-25
  • baxdrostat
  • Treatment of primary aldosteronism
  • Not available at present
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101407-PIP01-24-M02 (update)
  • chikungunya virus virus-like particle
  • Prevention of chikungunya virus disease
  • Vimkunya
  • Vimkunya
  • Infectious diseases
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101993-PIP01-25
  • avenciguat
  • Treatment of systemic sclerosis
  • Immunology -Rheumatology-Transplantation
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101244-PIP01-23-M01 (update)
  • UPADACITINIB
  • Treatment of vitiligo
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101212-PIP01-23-M02 (update)
  • ENMETAZOBACTAM
  • CEFEPIME DIHYDROCHLORIDE MONOHYDRATE
  • Treatment of infections caused by gram-negative organisms
  • EXBLIFEP
  • EXBLIFEP
  • EXBLIFEP
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102004-PIP01-25
  • olezarsen sodium
  • Treatment of familial chylomicronaemia syndrome
  • Tryngolza
  • Tryngolza
  • Cardiovascular Diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101172-PIP01-23-M01 (update)
  • Disitamab vedotin
  • Treatment of solid tumours, including central nervous system malignancies
  • Aidixi
  • Aidixi
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100820-PIP01-22-M03 (update)
  • Tirzepatide
  • Treatment of obesity
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro, Zepbound
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro, Zepbound
  • Mounjaro
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102146-PIP01-25
  • TROSPIUM CHLORIDE
  • xanomeline tartrate
  • Treatment of schizophrenia
  • Cobenfy
  • Cobenfy
  • Cobenfy
  • Cobenfy
  • Cobenfy
  • Cobenfy
  • Psychiatry
  • Other: Nervous System Disorders
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-102097-PIP01-25
  • Puxitatug samrotecan
  • Treatment of endometrial cancer
  • Treatment of lung cancer
  • Treatment of biliary tract cancer.
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102001-PIP01-25
  • FEZOLINETANT
  • Treatment of vasomotor symptoms caused by endocrine therapy related to breast cancer
  • Veoza
  • Veoza
  • VEOZA
  • Veozah
  • Veoza
  • Veozah
  • Veoza
  • Veoza
  • Veoza 45 mg
  • Veoza
  • Veozah
  • Veoza
  • Veoza
  • Veozah
  • Veoza
  • Other: Women's Health
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101622-PIP01-24-M01 (update)
  • Derivative of azabicycloheptane-carboxamide
  • Treatment of bronchiectasis
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102202-PIP01-25-M01 (update)
  • ONASEMNOGENE ABEPARVOVEC
  • Treatment of spinal muscular atrophy.
  • Zolgensma
  • Zolgensma
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100724-PIP01-22
  • Tozorakimab
  • Treatment of severe viral lower respiratory tract infection
  • Pneumology - Allergology
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-102165-PIP01-25
  • adeno-associated viral vector serotype Anc80 containing the 5' portion of human OTOF gene
  • adeno-associated viral vector serotype Anc80 containing the 3' portion of human OTOF gene
  • Treatment of otoferlin gene-mediated hearing loss
  • Oto-Rhino-Laryngology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes
MHRA-102170-PIP01-25-M01 (update)
  • asciminib hydrochloride
  • Treatment of chronic myeloid leukaemia.
  • Scemblix
  • Haematology-Hemostaseology
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100865-PIP01-23-M02 (update)
  • RILPIVIRINE
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • REKAMBYS
  • REKAMBYS
  • REKAMBYS
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100355-PIP02-22-M01 (update)
  • Fenebrutinib
  • Treatment of Multiple Sclerosis
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100140-PIP01-21-M01 (update)
  • BENRALIZUMAB
  • Treatment of Hypereosinophilic syndrome (HES)
  • FASENRA
  • FASENRA PEN
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA PEN
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • Other: Respiratory, thoracic and mediastinal disorders, Immune system disorders
PM: decision on the application for modification of an agreed paediatric investigation plan. No