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Displaying 141 - 160 of 961
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-101454-PIP01-24
  • Donidalorsen
  • Treatment of hereditary angioedema
  • Pneumology - Allergology
  • Haematology-Hemostaseology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 28/10/2024
MHRA-101395-PIP01-24
  • Zanidatamab
  • Treatment of biliary tract cancer (BTC).
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 28/10/2024
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 28/10/2024
MHRA-101356-PIP01-24
  • inebilizumab
  • Treatment of myasthenia gravis
  • Uplizna
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 28/10/2024
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 28/10/2024
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 28/10/2024
MHRA-101292-PIP01-23
  • Complement Factor B Antisense Oligonucleotide (RO7434656)
  • Treatment of primary immunoglobulin A nephropathy
  • Not available at present
  • Uro-Nephrology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 28/10/2024
MHRA-101307-PIP01-23
  • inaxaplin
  • Treatment of apolipoprotein L1 (APOL1) -mediated kidney disease
  • Uro-Nephrology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 28/10/2024
MHRA-101047-PIP01-23
  • vesleteplirsen
  • Treatment of Duchenne muscular dystrophy
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 28/10/2024
MHRA-100242-PIP01-21
  • Respiratory Syncytial Virus Stabilised Prefusion F Subunit Vaccine (RSVpreF, PF-06928316)
  • Prevention of lower respiratory tract disease caused by respiratory syncytial virus.
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 24/10/2024
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 03/10/2024
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 03/10/2024
MHRA-101120-PIP01-23
  • RVT-802 (allogeneic cultured postnatal thymus tissue-derived product)
  • Treatment of congenital athymia
  • RETHYMIC
  • RETHYMIC
  • Immunology -Rheumatology-Transplantation
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 03/10/2024
MHRA-100351-PIP01-21-M03 (update)
  • RILPIVIRINE
  • DOLUTEGRAVIR
  • Treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection.
  • JULUCA
  • JULUCA
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 03/10/2024
MHRA-100197-PIP01-21-M03 (update)
  • Ebola Zaire Vaccine (rVSV∆G-ZEBOV-GP, live)
  • Prevention of Ebola disease
  • ERVEBO
  • ERVEBO
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No 03/10/2024
MHRA-101439-PIP01-24-M01 (update)
  • (R)-1-(1-acryloylpiperidin-3-yl)-4-amino-3-(4-phenoxyphenyl)-1H-imidazo[4,5-c]pyridin-2(3H)-one
  • Treatment of Multiple Sclerosis
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 03/10/2024
MHRA-101513-PIP01-24-M01 (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
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 03/10/2024
MHRA-101494-PIP01-24-M01 (update)
  • LUSPATERCEPT
  • Treatment of myelodysplastic syndromes. Treatment of beta-thalassaemia.
  • Reblozyl
  • Reblozyl
  • Reblozyl
  • Reblozyl
  • Reblozyl
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 03/10/2024
MHRA-101078-PIP01-23-M02 (update)
  • OLAPARIB
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic, and lymphoid tissue).
  • Lynparza
  • Lynparza
  • Lynparza
  • Lynparza
  • Lynparza
  • Lynparza
  • Lynparza
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 03/10/2024
MHRA-101112-PIP01-23-M01 (update)
  • Interleukin-23 receptor antagonist peptide (JNJ-77242113)
  • Treatment of psoriasis.
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 03/10/2024