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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-100130-PIP01-21-M03 (update)
  • BUPIVACAINE
  • Postsurgical analgesia
  • EXPAREL liposomal
  • EXPAREL
  • EXPAREL
  • EXPAREL
  • EXPAREL
  • EXPAREL
  • EXPAREL
  • Pain
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100216-PIP01-21-M05 (update)
  • TRALOKINUMAB
  • Treatment of atopic dermatitis.
  • Adtralza
  • Adtralza
  • Adbry
  • Adtralza
  • Adtralza
  • Adtralza
  • Adtralza
  • Adtralza
  • Adtralza
  • Dermatology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100681-PIP01-22-M02 (update)
  • LOMITAPIDE MESYLATE
  • Treatment of heterozygous and homozygous familial hypercholesterolaemia
  • Lojuxta
  • Lojuxta
  • Lojuxta
  • Lojuxta
  • Juxtapid
  • Lojuxta
  • Juxtapid
  • Juxtapid
  • Juxtapid
  • Juxtapid
  • Other: Hypercholesterolaemia (HoFH)
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100709-PIP01-22-M02 (update)
  • Rozanolixizumab
  • Treatment of myasthenia gravis
  • Neurology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101857-PIP01-25
  • Humanised afucosylated IgG1 monoclonal antibody against CCR8
  • Treatment of all conditions included in the category of malignant neoplasms except melanoma, nervous system neoplasms, haematopoietic and lymphoid tissue neoplasms
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101404-PIP01-24-M01 (update)
  • TRASTUZUMAB DERUXTECAN
  • Treatment of all conditions in the category of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms)
  • Enhertu
  • Enhertu
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100145-PIP01-21-M02 (update)
  • BRIGATINIB
  • Treatment of non-small cell lung cancer (NSCLC)
  • Treatment of anaplastic large cell lymphoma (ALCL)
  • Treatment of Inflammatory myofibroblastic tumours
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101908-PIP01-25-M01 (update)
  • MOSUNETUZUMAB
  • Treatment of mature B-cell neoplasms
  • Lunsumio
  • Haematology-Hemostaseology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101447-PIP01-24-M02 (update)
  • DIFELIKEFALIN ACETATE
  • Treatment of chronic kidney disease associated pruritus.
  • Kapruvia
  • Kapruvia
  • Other: Nephrology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101916-PIP01-25
  • PF-07248144
  • Treatment of breast cancer
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101909-PIP01-25
  • 5,8-dichloro-2-[(4-methoxy-6-methyl-2-oxo-1,2-dihydropyridin-3-yl)methyl]-7-[(R)-methoxy(oxetan-3-yl)methyl]-3,4-dihydroisoquinolin-1(2H)-one
  • Treatment of prostate malignant neoplasms
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100462-PIP01-22-M03 (update)
  • FENFLURAMINE HYDROCHLORIDE
  • Treatment of Dravet syndrome.
  • Fintepla
  • Fintepla
  • Fintepla
  • Fintepla
  • Fintepla
  • Neurology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101159-PIP02-25
  • Sacituzumab Tirumotecan
  • Treatment of urothelial carcinoma
  • sac-TMT (佳泰莱®)
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101984-PIP01-25
  • obicetrapib
  • EZETIMIBE
  • Treatment of elevated cholesterol
  • Cardiovascular Diseases
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101781-PIP01-25
  • pozelimab
  • Treatment of paroxysmal nocturnal haemoglobinuria
  • Veopoz
  • Haematology-Hemostaseology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101782-PIP01-25
  • cemdisiran sodium
  • Treatment of paroxysmal nocturnal haemoglobinuria
  • Haematology-Hemostaseology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101471-PIP01-24
  • Respiratory syncytial virus, prefusion F protein, virus-like particle; Human metapneumovirus, prefusion F protein, virus-like particle
  • IVX-A12
  • Prevention of lower respiratory tract disease caused by respiratory syncytial virus
  • Prevention of lower respiratory tract disease caused by human metapneumovirus
  • Not available
  • Vaccines
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101995-PIP01-25-M01 (update)
  • ISOFLURANE
  • Sedation of mechanically ventilated patients
  • Sedaconda and associated names
  • Other: Sedation
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100447-PIP01-22-M03 (update)
  • Tirzepatide
  • Treatment of Type 2 diabetes mellitus.
  • 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, Zepbound
  • Endocrinology-Gynaecology-Fertility-metabolism
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100289-PIP01-21-M04 (update)
  • GALCANEZUMAB
  • Prevention of migraine headaches.
  • Emgality
  • Emgality 120 mg solution for injection in pre-filled syringe
  • Neurology
  • Pain
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
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