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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-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-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-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-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-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-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-100811-PIP01-22-M01 (update)
  • Vamorolone
  • Treatment of Duchenne muscular dystrophy
  • Other: Neuromuscular Diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 25/05/2023
MHRA-100811-PIP01-22-M02 (update)
  • Vamorolone
  • Treatment of Duchenne muscular dystrophy
  • AGAMREE
  • Neurology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
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
MHRA-100186-PIP01-21
  • depemokimab
  • Treatment of chronic rhinosinusitus with nasal polyps (CRSwNP)
  • Depemokimab
  • Pneumology - Allergology
 W: decision granting a waiver in all age groups for the listed condition(s). No 25/05/2023
MHRA-100894-PIP01-23
  • depemokimab
  • Treatment of Eosinophilic granulomatosis with polyangiitis (EGPA)
  • Pneumology - Allergology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 19/12/2023
MHRA-100635-PIP01-22
  • CEDAZURIDINE
  • DECITABINE
  • Treatment of acute myeloid leukaemia
  • INQOVI
  • INQOVI
  • Inqovi 35/100
  • INAQOVI
  • Haematology-Hemostaseology
  • Oncology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 25/05/2023
MHRA-100605-PIP01-22
  • sparsentan
  • Treatment of 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) Yes Partial Compliance Check Granted 25/05/2023
MHRA-100606-PIP01-22
  • sparsentan
  • Treatment of focal segmental glomerulosclerosis
  • Not available at present
  • Uro-Nephrology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 25/05/2023
MHRA-100606-PIP01-22-M01 (update)
  • sparsentan
  • Treatment of focal segmental glomerulosclerosis
  • Filspari
  • Filspari
  • Uro-Nephrology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100559-PIP01-22
  • mitapivat
  • Treatment of thalassaemia
  • PYRUKYND
  • PYRUKYND
  • Haematology-Hemostaseology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 25/05/2023
MHRA-100628-PIP01-22
  • Sibeprenlimab
  • Treatment of primary immunoglobulin A nephropathy
  • Uro-Nephrology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 25/05/2023
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