Displaying 1 - 20 of 1085
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-101185-PIP01-23-M01 (update)
  • gefurulimab
  • Treatment of myasthenia gravis
  • KLYGEFA
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102433-PIP01-26
  • MK-8748/EYE201
  • Treatment of age-related macular degeneration.
  • Ophthamology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100721-PIP01-22-M01 (update)
  • Tividenofusp alfa
  • Treatment of mucopolysaccharidosis II (Hunter syndrome)
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102310-PIP01-26
  • surabgene lomparvovec
  • Treatment of diabetic retinopathy
  • Ophthamology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100648-PIP01-22-M02 (update)
  • TECOVIRIMAT MONOHYDRATE
  • Treatment of orthopoxvirus disease (smallpox, mpox, cowpox, and vaccinia)
  • Tecovirimat SIGA
  • Tecovirimat SIGA
  • TPOXX
  • TPOXX
  • TEPOXX
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100679-PIP01-22-M01 (update)
  • Talazoparib
  • Treatment of Ewing Sarcoma
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102324-PIP01-26-M01 (update)
  • CABOZANTINIB
  • Treatment of malignant solid tumours
  • Cabometyx
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-101849-PIP01-25
  • lemborexant
  • Treatment of chronic insomnia
  • Not available at present
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Psychiatry
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-102312-PIP01-26
  • EYE103/MK-3000
  • Treatment of age-related macular degeneration.
  • Ophthamology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101008-PIP01-23-M02 (update)
  • AMBRISENTAN
  • Treatment of pulmonary arterial hypertension.
  • Volibris
  • Volibris
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102388-PIP01-26
  • Rinzimetostat
  • Treatment of prostate malignant neoplasms
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102425-PIP01-26
  • PF-08634404
  • Treatment of all conditions included in the category of malignant neoplasms (except melanoma, central nervous system, haematopoietic and lymphoid tissue)
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102499-PIP01-26
  • etalanetug
  • Treatment of Alzheimer's disease
  • Not Yet Available
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101021-PIP01-23-M04 (update)
  • FILGOTINIB MALEATE
  • Chronic idiopathic arthritis
  • Jyseleca
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102520-PIP01-26
  • 2'-methoxyethyl antisense gapmer oligonucleotide against MAPT mRNA
  • Treatment of progressive supranuclear palsy.
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102389-PIP01-26
  • Humanised IgG4 monoclonal antibody against S100A4
  • Treatment of idiopathic pulmonary fibrosis
  • Not available at present
  • Pneumology - Allergology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102112-PIP01-25
  • Retatrutide
  • Obesity
  • Other: Obesity, Overweight
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-102249-PIP01-25-M01 (update)
  • ESTETROL MONOHYDRATE
  • DROSPIRENONE
  • Prevention of pregnancy
  • Drovelis
  • Nextstellis
  • Lydisilka
  • Nextstellis
  • Drovelis, Lydisilka
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-102435-PIP01-26
  • MK-8748/EYE201
  • Treatment of diabetic macular oedema
  • Ophthamology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101094-PIP01-23-M03 (update)
  • GIVINOSTAT HYDROCHLORIDE MONOHYDRATE
  • Treatment of Duchenne muscular dystrophy
  • Duvyzat
  • Duvyzat 8.86 mg/ml oral suspension
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No