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Displaying 61 - 80 of 875
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
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-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-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
MHRA-102113-PIP01-25
  • aglatimagene besadenovec
  • Treatment of prostate cancer
  • Treatment of Non-small cell lung cancer
  • Treatment of Pancreatic cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102051-PIP01-25
  • Veligrotug
  • Treatment of thyroid eye disease
  • Endocrinology-Gynaecology-Fertility-metabolism
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101982-PIP01-25
  • obicetrapib
  • Treatment of elevated cholesterol
  • Ubeslo
  • Cardiovascular Diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101519-PIP01-24
  • Mezagitamab
  • Treatment of Immune thrombocytopenia
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100910-PIP01-23-M04 (update)
  • ABEMACICLIB
  • Treatment of glioma
  • Abemaciclib
  • Verzenios
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102076-PIP01-25
  • EMICIZUMAB
  • Treatment of von Willebrand Disease.
  • Hemlibra
  • Hemlibra
  • Hemlibra
  • Hemlibra
  • Hemlibra
  • Hemlibra
  • Hemlibra
  • Hemlibra
  • Hemlibra
  • Haematology-Hemostaseology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100885-PIP01-23-M01 (update)
  • IPTACOPAN HYDROCHLORIDE MONOHYDRATE
  • Treatment of paroxysmal nocturnal haemoglobinuria (PNH)
  • Fabhalta
  • Fabhalta
  • Fabhalta
  • Fabhalta
  • Fabhalta
  • Fabhalta
  • Fabhalta
  • Fabhalta
  • Fabhalta
  • Fabhalta
  • Fabhalta
  • Fabhalta
  • Fabhalta
  • Fabhalta
  • Fabhalta
  • Fabhalta
  • Fabhalta
  • Fabhalta
  • Fabhalta
  • Fabhalta
  • Fabhalta
  • Haematology-Hemostaseology
  • Other: Complement inhibitor
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102164-PIP01-25
  • ZANUBRUTINIB
  • Treatment of lymphoplasmacytic lymphoma
  • Treatment of mature B-Cell neoplasms (excluding lymphoplasmacytic lymphoma)
  • Brukinsa
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101772-PIP01-24
  • Mezagitamab
  • Treatment of primary immunoglobulin A nephropathy
  • Not available at present
  • Haematology-Hemostaseology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No