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PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-101410-PIP01-24
  • ISATUXIMAB
  • Treatment of malignant neoplasms of the haematopoietic and lymphoid tissue
  • Sarclisa
  • Sarclisa
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101334-PIP01-24
  • Insulin Efsitora Alfa (LY3209590)
  • Treatment of type 1 diabetes mellitus
  • Treatment of type 2 diabetes mellitus
  • Endocrinology-Gynaecology-Fertility-metabolism
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101333-PIP01-24
  • 2-(3,5-dichloro-1-methyl-indazol-4-yl)-1-[(1S,3R)-3-(hydroxymethyl)-5-(1-hydroxy-1-methyl-ethyl)-1-methyl-3,4-dihydro-1H-isoquinolin-2-yl]ethanone monohydrate
  • Treatment of Parkinson's disease
  • Neurology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101170-PIP01-23
  • IRINOTECAN HYDROCHLORIDE TRIHYDRATE
  • Treatment of pancreatic cancer
  • ONIVYDE pegylated liposomal 4.3 mg/ml concentrate for dispersion for infusion
  • ONIVYDE pegylated liposomal
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101132-PIP01-23
  • Vepdegestrant
  • Treatment breast malignant neoplasms
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101468-PIP01-24
  • DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE
  • baxdrostat
  • Treatment of Chronic Kidney Disease
  • Uro-Nephrology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101431-PIP01-24
  • SODIUM PHENYLBUTYRATE
  • Ursodoxicoltaurine
  • Treatment of progressive supranuclear palsy
  • Relyvrio
  • Albrioza
  • Neurology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101326-PIP01-24
  • Human IgG4 monoclonal antibody against BCMA and CD3
  • Treatment of multiple myeloma
  • Not available at present
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101338-PIP01-24
  • elinzanetant
  • Treatment of vasomotor symptoms caused by endocrine therapy related to breast cancer
  • Endocrinology-Gynaecology-Fertility-metabolism
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101186-PIP01-23
  • FARICIMAB
  • Treatment of choroidal neovascularisation secondary to pathologic myopia
  • Vabysmo
  • Vabysmo
  • Ophthamology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101288-PIP01-23
  • Interleukin-2
  • Interleukin-1 beta, human
  • Granulocyte colony-stimulating factor
  • Tumor necrosis factor-alpha
  • Interferon gamma
  • Treatment of squamous cell carcinoma of the head and neck (SCCHN)
  • Multikine
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101007-PIP01-23
  • tiragolumab
  • ATEZOLIZUMAB
  • Treatment of lung carcinoma (non-small cell carcinoma)
  • Not available at present
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101204-PIP01-23
  • Ravulizumab (ALXN1210)
  • Prevention of kidney injury in high-risk patients with chronic kidney disease undergoing cardiopulmonary bypass
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Uro-Nephrology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101127-PIP01-23
  • Zimberelimab
  • Treatment of lung cancer
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101126-PIP01-23
  • Zimberelimab
  • Treatment of gastric and gastroesophageal junction adenocarcinoma. Treatment of oesophageal carcinoma.
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101301-PIP01-23
  • Fusion protein consisting of relaxin and Fc domain of IgG1
  • Treatment of pulmonary hypertension due to left heart disease.
  • Not available at present
  • Cardiovascular Diseases
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101315-PIP01-23
  • NIVOLUMAB
  • relatlimab
  • Treatment of all conditions in the category of malignant neoplasms (except nervous system neoplasms, haematopoietic and lymphoid tissue neoplasms and melanoma)
  • Opdualag
  • Opdualag
  • Opdualag
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101313-PIP01-23
  • maplirpacept
  • Treatment of multiple myeloma.
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101247-PIP01-23
  • empasiprubart
  • Treatment of multifocal motor neuropathy
  • empasiprubart
  • Neurology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101236-PIP01-23
  • Rilzabrutinib
  • Treatment of autoimmune haemolytic anaemia.
  • Haematology-Hemostaseology
 W: decision granting a waiver in all age groups for the listed condition(s). No
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