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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-100479-PIP01-22-M01 (update)
  • POSACONAZOLE
  • Prevention of invasive fungal infections
  • Treatment of invasive fungal infections
  • Noxafil
  • Noxafil
  • Noxafil
  • Noxafil
  • Noxafil
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100524-PIP01-22-M01 (update)
  • gadopiclenol
  • Diagnostic detection & visualisation of areas with BBB disruption and/or abnormal vascularity
  • Not available at present
  • Diagnostic
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 07/12/2022
MHRA-100523-PIP01-22-M01 (update)
  • gadopiclenol
  • Diagnostic detection & visualisation of areas with BBB disruption and/or abnormal vascularity
  • Not available at present
  • Diagnostic
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 07/12/2022
MHRA-100148-PIP01-21-M02 (update)
  • LENVATINIB MESILATE
  • Malignant neoplasms except haematopoietic, lymphoid, papillary & follicular thyroid, &osteosarcoma
  • Lenvima
  • Kisplyx
  • Lenvima
  • Kisplyx
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100507-PIP01-22-M01 (update)
  • BREXPIPRAZOLE
  • Treatment of schizophrenia
  • RXULTI
  • RXULTI
  • Psychiatry
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100492-PIP01-22-M01 (update)
  • MOLGRAMOSTIM
  • Treatment of pulmonary alveolar proteinosis
  • Not available at present
  • Pneumology - Allergology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100502-PIP01-22-M01 (update)
  • Recombinant Influenza Hemagglutinin-strain A (H1N1 subtype)
  • Recombinant Influenza Hemagglutinin-strain A (H3N2 subtype)
  • Recombinant Influenza Hemagglutinin-strain B (Victoria lineage)
  • Recombinant Influenza Hemagglutinin-strain B (Yamagata lineage)
  • Prevention of influenza infection
  • Supemtek
  • Supemtek
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 07/12/2022
MHRA-100476-PIP01-22
  • Anti-(alpha-synuclein) human monoclonal antibody
  • Treatment of Multiple System Atrophy
  • Treatment of Parkinson's Disease
  • Neurology
 W: decision granting a waiver in all age groups for the listed condition(s). No 07/12/2022
MHRA-100481-PIP01-22
  • TUCATINIB
  • Treatment of solid tumours
  • Tukysa
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No 07/12/2022
MHRA-100404-PIP01-21
  • insulin icodec
  • SEMAGLUTIDE
  • 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 07/12/2022
MHRA-100365-PIP01-21
  • Batiraxcept
  • Treatment of Ovarian cancer
  • Treatment of Fallopian tube cancer
  • Treatment of Primary peritoneal cancer
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No 07/12/2022
MHRA-100395-PIP01-21
  • TALAZOPARIB TOSYLATE
  • Treatment of breast malignant neoplasms
  • Treatment of prostate malignant neoplasms
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
  • Psychiatry
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No 07/12/2022
MHRA-100366-PIP01-21
  • Cevostamab
  • Treatment of multiple myeloma
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No 07/12/2022
MHRA-100383-PIP01-21
  • TRASTUZUMAB DERUXTECAN
  • Treatment of lung cancer
  • Enhertu
  • Enhertu
  • Enhertu
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No 07/12/2022
MHRA-100465-PIP01-22-M01 (update)
  • efanesoctocog alfa
  • Treatment of congenital haemophilia A
  • Haematology-Hemostaseology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100455-PIP01-22-M01 (update)
  • IXAZOMIB
  • Treatment of multiple myeloma
  • Treatment of lymphoid malignancies (excluding multiple myeloma)
  • Ninlaro
  • Ninlaro
  • Ninlaro
  • Ninlaro
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100447-PIP01-22-M01 (update)
  • tirzepatide
  • Treatment of Type 2 Diabetes Mellitus
  • Not available at present
  • Endocrinology-Gynaecology-Fertility-metabolism
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 07/12/2022
MHRA-100444-PIP01-22-M01 (update)
  • ETELCALCETIDE
  • Treatment of hyperparathyroidism
  • Parsabiv
  • Parsabiv
  • Uro-Nephrology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100441-PIP01-22-M01 (update)
  • Delandistrogene moxeparvovec
  • Treatment of Duchenne Muscular Dystrophy (DMD)
  • Elevidys
  • Neurology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100412-PIP01-22-M02 (update)
  • vadadustat
  • Treatment of anaemia due to chronic disorders
  • VAFSEO
  • VAFSEO
  • Haematology-Hemostaseology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
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