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PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-101954-PIP01-25
  • N. meningitidis serogroup Y polysaccharide conjugated to Corynebacterium diphtheriae (C. diphtheriae) CRM197 protein
  • N. meningitidis serogroup W polysaccharide conjugated to Corynebacterium diphtheriae (C. diphtheriae) CRM197 protein
  • N. meningitidis serogroup X polysaccharide conjugated to Purified Tetanus Toxoid
  • N. meningitidis serogroup C polysaccharide conjugated to Corynebacterium diphtheriae (C. diphtheriae) CRM197 protein
  • Neisseria meningitidis (N. meningitidis) serogroup A polysaccharide conjugated to Purified Tetanus Toxoid
  • Prevention of invasive meningococcal disease
  • MenFive
  • MenFive
  • MenFive
  • MenFive
  • MenFive
  • MenFive
  • MenFive
  • MenFive
  • SILMEN-5
  • MenFive
  • MenFive
  • MENVAID
  • MenFive
  • MenFive
  • MenFive
  • Vaccines
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Full Compliance Check Granted
MHRA-102339-PIP01-26
  • Zelenectide pevedotin
  • Treatment of urothelial carcinoma.
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102320-PIP01-26
  • Zelenectide pevedotin
  • Treatment of breast cancer
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101810-PIP01-25
  • Livmoniplimab
  • Treatment of all conditions included in the category of malignant neoplasms except melanoma, central nervous neoplasms, haematopoietic and lymphoid tissues neoplasms.
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102212-PIP01-25
  • sotatercept
  • Treatment of pulmonary hypertension due to left heart disease
  • Cardiovascular Diseases
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101986-PIP01-25
  • CEMIPLIMAB
  • FIANLIMAB
  • Treatment of melanoma
  • Oncology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101786-PIP01-25
  • (R)-N-(3-(2-Chloro-5-fluorophenyl)-6-(5-cyano-[1,2,4]triazolo[1,5-a]pyridin-6-yl)-1-oxoisoindolin-4-yl)-3-fluoro-5-(trifluoromethyl)benzamide
  • Treatment of PIK3CA-related disorders with vascular malformations and/or overgrowth spectrum
  • Other: Vascular disorders; Congenital, hereditary, and genetic disorders
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100143-PIP01-21-M03 (update)
  • TENOFOVIR ALAFENAMIDE FUMARATE
  • Treatment of chronic viral hepatitis B
  • Vemlidy
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102192-PIP01-25
  • casdatifan
  • Treatment of renal cell carcinoma (RCC)
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100079-PIP01-21-M05 (update)
  • GILTERITINIB FUMARATE
  • Treatment of acute myeloid leukaemia (AML)
  • Xospata
  • Gilteritinib Astellas
  • Haematology-Hemostaseology
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102232-PIP01-25
  • Napazimone
  • Treatment of primary mitochondrial disease
  • Other: Genetic mitochondrial abnormalities NEC
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101894-PIP01-25
  • nomlabofusp
  • Treatment of Friedreich’s ataxia
  • Neurology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101880-PIP02-25
  • Duvakitug
  • Treatment of Crohn’s disease
  • Gastroenterology-Hepatology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101513-PIP01-24-M02 (update)
  • ERTUGLIFLOZIN L-PYROGLUTAMIC ACID
  • Treatment of Type 2 Diabetes Mellitus
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Endocrinology-Gynaecology-Fertility-metabolism
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-100332-PIP01-21-M01 (update)
  • sotatercept
  • Treatment of pulmonary arterial hypertension
  • Not available at present
  • Cardiovascular Diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100329-PIP01-21-M01 (update)
  • EDOXABAN TOSYLATE
  • Treatment of venous thromboembolism
  • Prevention of arterial thromboembolism
  • Prevention of Venous thromboembolism
  • Lixiana film-coated tablets
  • Lixiana
  • Cardiovascular Diseases
  • Haematology-Hemostaseology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100327-PIP01-21-M02 (update)
  • SELPERCATINIB
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms).
  • Retsevmo
  • Retsevmo
  • Retevmo
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100324-PIP01-21-M01 (update)
  • Loncastuximab tesirine
  • Treatment of mature B-cell neoplasms
  • Zynlonta
  • Zynlonta
  • Zynlonta
  • Zynlonta
  • Zynlonta
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100323-PIP01-21-M02 (update)
  • SAXAGLIPTIN
  • Treatment of Type 2 Diabetes Mellitus
  • Onglyza
  • Onglyza
  • Onglyza
  • Onglyza
  • Onglyza
  • Endocrinology-Gynaecology-Fertility-metabolism
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100300-PIP01-21-M03 (update)
  • DARUNAVIR
  • COBICISTAT
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
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