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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-100224-PIP01-21-M01 (update)
  • Etrasimod L-arginine
  • Treatment of ulcerative colitis
  • Gastroenterology-Hepatology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 25/05/2023
MHRA-100630-PIP01-22-M01 (update)
  • PATIROMER SORBITEX CALCIUM
  • Treatment of hyperkalaemia
  • Veltassa
  • Other: Nephrology/Metabolism
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 25/05/2023
MHRA-100552-PIP01-22-M01 (update)
  • RILPIVIRINE HYDROCHLORIDE
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • edurant
  • edurant
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 25/05/2023
MHRA-100496-PIP01-22-M01 (update)
  • RUXOLITINIB PHOSPHATE
  • Treatment of acute Graft versus Host Disease (aGvHD)
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 25/05/2023
MHRA-100517-PIP01-22-M01 (update)
  • APREMILAST
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and juvenile idiopathic arthritis)
  • Otezla
  • Otezla
  • Otezla
  • Immunology -Rheumatology-Transplantation
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100392-PIP01-21-M02 (update)
  • TOZINAMERAN
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Comirnaty
  • Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100518-PIP01-22-M01 (update)
  • APREMILAST
  • Treatment of Behçet’s Disease
  • Otezla
  • Otezla
  • Otezla
  • Otezla
  • Immunology -Rheumatology-Transplantation
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100505-PIP01-22-M01 (update)
  • copanlisib dihydrochloride
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue)
  • Treatment of mature B-cell neoplasms
  • Aliqopa
  • Aliqopa
  • Aliqopa
  • Aliqopa
  • Aliqopa
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100443-PIP01-22-M01 (update)
  • BARICITINIB
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, ankylosing spondylarthritis, psoriatic arthritis and juvenile idiopathic arthritis)
  • Olumiant
  • Olumiant
  • Immunology -Rheumatology-Transplantation
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 25/05/2023
MHRA-100116-PIP01-21-M02 (update)
  • IVACAFTOR
  • TEZACAFTOR
  • ELEXACAFTOR
  • Treatment of cystic fibrosis
  • Kaftrio
  • Trikafta
  • Trikafta
  • Trikafta
  • Trikafta
  • Trikafta
  • Trikafta
  • Trikafta
  • Kaftrio
  • Kaftrio
  • Trikafta
  • Trikafta
  • Trikafta
  • Trikafta
  • Kaftrio
  • Pneumology - Allergology
  • Other: Congenital, hereditary and neonatal diseases and abnormalities
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100485-PIP01-22-M01 (update)
  • AMG 176 (4S,7aR,9aR,10S,11E,14S,15R)-6'-chloro-10-methoxy-14,15-dimethyl-3',4',7a,8,9,9a,10,13,14,15-decahydro-2'H,7H-spiro[1,19-ethenocyclobuta[i][1,4]oxazepino[3,4f][1,2,7]thiadiazacyclohexadecine-4,1'-naphthalen]-18(17H)-one 16,16-dioxide
  • Treatment of acute myeloid leukaemia
  • Tapotoclax
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100463-PIP01-22-M01 (update)
  • spesolimab
  • Treatment of Generalised Pustular Psoriasis
  • Prevention of Generalised Pustular Psoriasis
  • Dermatology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100274-PIP01-21-M01 (update)
  • ELIGLUSTAT
  • Treatment of Gaucher Disease type 2
  • Treatment of Gaucher Disease Type 1 and Type 3
  • CERDELGA
  • Other: Lysosomal Storage Disorder
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100214-PIP01-21-M03 (update)
  • RAVULIZUMAB
  • atypical haemolytic uremic syndrome (aHUS)
  • Haematology-Hemostaseology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 25/05/2023
MHRA-100213-PIP01-21-M03 (update)
  • RAVULIZUMAB
  • Treatment of paroxysmal nocturnal haemoglobinuria (PNH)
  • Ultomiris
  • Haematology-Hemostaseology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 25/05/2023
MHRA-100274-PIP01-21-M02 (update)
  • ELIGLUSTAT
  • Treatment of Gaucher Disease Type 2
  • Treatment of Gaucher Disease Type 1 and Type 3
  • CERDELGA
  • Other: Lysosomal Storage Disorder
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100811-PIP01-22
  • Vamorolone
  • Treatment of Duchenne muscular dystrophy
  • AGAMREE
  • Other: Neuromuscular Diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100637-PIP01-22
  • Mixture of 2 synthetic double-stranded N-Acetyl-galactosamine conjugated siRNA oligonucleotides that are directed against hepatitis B virus
  • Treatment of chronic hepatitis D infection
  • Not available at present
  • Infectious diseases
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 25/05/2023
MHRA-100545-PIP01-22
  • Lutetium (177Lu) edotreotide
  • Treatment of gastro-entero-pancreatic neuroendocrine tumours (GEP-NETs)
  • Oncology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 25/05/2023
MHRA-100316-PIP02-22
  • latozinemab
  • Treatment of Amyotrophic lateral sclerosis
  • Neurology
 W: decision granting a waiver in all age groups for the listed condition(s). No 25/05/2023
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