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Displaying 1 - 20 of 783
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-101985-PIP01-25
  • obicetrapib
  • EZETIMIBE
  • Treatment of mixed dyslipidaemia
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101808-PIP01-25-M01 (update)
  • DARVADSTROCEL
  • Treatment of perianal fistula
  • Alofisel
  • Gastroenterology-Hepatology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101467-PIP01-24-M01 (update)
  • apitegromab
  • Treatment of spinal muscular atrophy
  • Isembyld
  • Other: Neuromuscular disorders
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100369-PIP01-21-M03 (update)
  • MIGALASTAT HYDROCHLORIDE
  • Treatment of Fabry disease
  • Galafold
  • Galafold
  • Galafold
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101592-PIP01-24
  • Afimkibart
  • Treatment of Crohn's disease
  • Human IgG1 kappa monoclonal antibody against tumor necrosis factor-like ligand 1A
  • Gastroenterology-Hepatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101549-PIP01-24
  • Afimkibart
  • Treatment of ulcerative colitis
  • Gastroenterology-Hepatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100635-PIP01-22-M03 (update)
  • CEDAZURIDINE
  • DECITABINE
  • Treatment of acute myeloid leukaemia
  • INAQOVI
  • INAQOVI
  • INQOVI
  • INQOVI
  • Inqovi 35/100
  • Haematology-Hemostaseology
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100182-PIP01-21-M02 (update)
  • Avalglucosidase alfa
  • Treatment of Pompe disease.
  • Nexviadyme
  • Nexviadyme
  • Nexviadyme
  • Nexviadyme
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100149-PIP01-21-M04 (update)
  • NVX-CoV2373
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Nuvaxovid dispersion for injection, COVID-19 Vaccine (recombinant, adjuvanted)
  • Nuvaxovid
  • Nuvaxovid
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101983-PIP01-25
  • obicetrapib
  • Treatment of mixed dyslipidaemia
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102020-PIP01-25-M01 (update)
  • tezepelumab
  • Treatment of asthma
  • TEZSPIRE
  • TEZSPIRE
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100092-PIP01-21-M04 (update)
  • VENETOCLAX
  • Treatment of malignant neoplasms of the haematopoietic and lymphoid tissue
  • Treatment of solid malignant tumours
  • Venclyxto
  • Venclyxto
  • Venclyxto
  • Venclyxto
  • Venclyxto
  • Venclyxto
  • Venclyxto
  • Venclyxto
  • Haematology-Hemostaseology
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
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-101953-PIP01-25-M01 (update)
  • Nipocalimab
  • Treatment of myasthenia gravis
  • Not available at present
  • Neurology
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-101641-PIP01-24
  • Japanese encephalitis virus, strain SA14-14-2, Live
  • Prevention of Japanese encephalitis
  • IMOJEV
  • IMOJEV
  • IMOJEV
  • Infectious diseases
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(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