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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-100408-PIP01-21-M01 (update)
  • Hepatitis B (rDNA) surface antigen adjuvanted
  • Prevention of hepatitis B virus infection
  • HEPLISAV B
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100333-PIP01-21-M01 (update)
  • MIRABEGRON
  • Treatment of neurogenic detrusor overactivity
  • BETMIGA
  • BETMIGA
  • MYRBETRIQ / MYRBETRIQ GRANULES
  • Uro-Nephrology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100329-PIP01-21-M01 (update)
  • EDOXABAN TOSYLATE
  • Treatment of venous thromboembolism
  • Prevention of arterial thromboembolism
  • Prevention of Venous thromboembolism
  • Lixiana film-coated tablets
  • Lixiana
  • Cardiovascular Diseases
  • Haematology-Hemostaseology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100302-PIP01-21-M01 (update)
  • CRIZANLIZUMAB
  • Treatment of sickle cell disease
  • Adakveo® 10 mg/ml concentrate for solution for infusion
  • Haematology-Hemostaseology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100296-PIP01-21-M01 (update)
  • palovarotene
  • Treatment of fibrodysplasia ossificans progressiva
  • SOHONOS
  • Other: Musculo-skeletal
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100211-PIP01-21-M01 (update)
  • VOLANESORSEN SODIUM
  • Treatment of familial chylomicronemia syndrome
  • WAYLIVRA
  • WAYLIVRA
  • Gastroenterology-Hepatology
  • Cardiovascular Diseases
  • Endocrinology-Gynaecology-Fertility-metabolism
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100401-PIP01-21
  • Humanised IgG2k Fc-modified bispecific antibody against CD3 and BCMA (PF-06863135)
  • Treatment of multiple myeloma
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100432-PIP01-22
  • 2-Amino-N-(4-hydroxybicyclo[2.2.2]octan-1-yl)-5-(4-((1R,5S)-3- (tetrahydro-2H-pyran-4-yl)-3-azabicyclo[3.1.0]hexan-1- yl)phenyl)nicotinamide fumarate dihydrate
  • Treatment of fibrodysplasia ossificans progressiva
  • Endocrinology-Gynaecology-Fertility-metabolism
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100030-PIP01-21
  • 9-valent vaccine consisting of the O-antigen polysaccharides of the extraintestinal pathogenic Escherichia coli (ExPEC) serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B and O75 bioconjugated to the carrier exoprotein A (EPA), a genetically detoxified protein from Pseudomonas aeruginosa (ExPEC9V)
  • Prevention of infections caused by extraintestinal pathogenic Escherichia coli (ExPEC)
  • Vaccines
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100398-PIP01-21
  • ralmitaront
  • Treatment of schizophrenia
  • Psychiatry
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100403-PIP01-21
  • Fusion protein composed of the first 2 immunoglobulin (Ig)-like domains of the human ROBO2 fused to human IgG1 Fc (PF-06730512)
  • 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
MHRA-100257-PIP01-21
  • 2-[(4-{6-[(4-cyano-2-fluorobenzyl)oxy]pyridin-2-yl}piperidin-1-yl)methyl]-1-[(2S)-oxetan-2-ylmethyl]-1H-benzimidazole-6-carboxylic acid tris(hydroxymethyl)aminomethane salt (1:1)
  • PF-06882961
  • Treatment of Type 2 Diabetes Mellitus
  • Not available at present
  • Endocrinology-Gynaecology-Fertility-metabolism
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100516-PIP01-22
  • Toripalimab
  • Malignant neoplasms (except CNS, haematopoietic and lymphoid tissue and melanoma).
  • Not available at present
  • TUOYI
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100480-PIP01-22
  • (S)-5-amino-3-(4-((5-fluoro-2-methoxybenzamido)methyl)phenyl)-1-(1,1,1-trifluoropropane-2-yl)-1H-pyrazole-4-carboxamide
  • Treatment of mature B-cell malignancies
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100386-PIP01-21
  • patritumab deruxtecan
  • Treatment of lung cancer
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100385-PIP01-21
  • datopotamab deruxtecan
  • Treatment of breast cancer
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100384-PIP01-21
  • datopotamab deruxtecan
  • Treatment of lung cancer
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100311-PIP01-21
  • Cetrelimab
  • Treatment of urothelial carcinoma
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100326-PIP01-21
  • GEMCITABINE HYDROCHLORIDE
  • Treatment of urothelial carcinoma
  • Not available at present
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100246-PIP01-21
  • MK-1026
  • Treatment of mature B-cell malignancies
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
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