Displaying 1 - 20 of 137
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-100301-PIP01-21
  • Anti-neonatal Fc receptor human monoclonal antibody(Nipocalimab )
  • Treatment of chronic inflammatory demyelinating polyradiculoneuropathy
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No 19/05/2022
MHRA-100309-PIP01-21
  • gantenerumab
  • Prevention of Alzheimer's disease
  • Not available at present
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No 19/05/2022
MHRA-100206-PIP01-21
  • EMPAGLIFLOZIN
  • Treatment of ischaemic heart disease
  • Jardiance
  • Jardiance
  • Endocrinology-Gynaecology-Fertility-metabolism
W: decision granting a waiver in all age groups for the listed condition(s). No 19/05/2022
MHRA-100194-PIP01-21
  • sivopixant
  • Treatment of unexplained or refractory chronic cough
  • Pneumology - Allergology
W: decision granting a waiver in all age groups for the listed condition(s). No 19/05/2022
MHRA-100204-PIP01-21
  • verdiperstat
  • Treatment of Amyotrophic lateral sclerosis
  • Dazluma
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No 19/05/2022
MHRA-100195-PIP01-21-M01 (update)
  • BALOXAVIR MARBOXIL
  • Treatment of Influenza
  • Prevention of Influenza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 18/05/2022
MHRA-100184-PIP01-21
  • BENRALIZUMAB
  • Non-cystic fibrosis bronchiectasis with an eosinophilic phenotype
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • Pneumology - Allergology
W: decision granting a waiver in all age groups for the listed condition(s). No 17/05/2022
MHRA-100135-PIP01-21
  • anti-CD40L humanized monoclonal antibody (SAR441344)
  • Treatment of Sjogren's Syndrome
  • Immunology -Rheumatology-Transplantation
W: decision granting a waiver in all age groups for the listed condition(s). No 17/05/2022
MHRA-100426-PIP01-22-M01 (update)
  • ligelizumab
  • Treatment of chronic spontaneous urticaria
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/05/2022
MHRA-100412-PIP01-22-M01 (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. Yes Partial Compliance Check Granted 17/05/2022
MHRA-100342-PIP01-21-M01 (update)
  • arimoclomol citrate
  • Treatment of Niemann-Pick Disease, type C
  • MIPLYFFA
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/05/2022
MHRA-100327-PIP01-21-M01 (update)
  • SELPERCATINIB
  • Treatment of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms).
  • Retsevmo
  • Retsevmo
  • Retevmo
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 17/05/2022
MHRA-100320-PIP01-21-M01 (update)
  • REMDESIVIR
  • Treatment of coronavirus disease 2019 (COVID-19)
  • VEKLURY
  • VEKLURY
  • VEKLURY
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/05/2022
MHRA-100264-PIP01-21-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 17/05/2022
MHRA-100262-PIP01-21-M01 (update)
  • DALBAVANCIN HYDROCHLORIDE
  • Treatment of acute bacterial skin and skin structure infections (ABSSSI)
  • Xydalba
  • Xydalba
  • Dalvance
  • Xydalba
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 17/05/2022
MHRA-100248-PIP01-21-M01 (update)
  • RISDIPLAM
  • Treatment of spinal muscular atrophy
  • Evrysdi
  • Evrysdi
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 17/05/2022
MHRA-100247-PIP01-21-M01 (update)
  • BEROTRALSTAT DIHYDROCHLORIDE
  • Treatment of hereditary angioedema
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/05/2022
MHRA-100229-PIP01-21-M01 (update)
  • NINTEDANIB
  • Treatment of fibrosing Interstitial Lung Diseases (ILD)
  • Ofev
  • Vargatef
  • Ofev
  • Vargatef
  • Pneumology - Allergology
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/05/2022
MHRA-100217-PIP01-21-M01 (update)
  • ERIBULIN
  • Treatment of soft tissue sarcoma
  • Halaven
  • Halaven
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted 17/05/2022
MHRA-100216-PIP01-21-M01 (update)
  • TRALOKINUMAB
  • Treatment of atopic dermatitis
  • Adtralza
  • Adtralaza
  • Adtralza
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/05/2022