Displaying 1 - 20 of 968
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-102127-PIP01-25
  • BI 1584862
  • Treatment of age-related macular degeneration
  • Ophthamology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100779-PIP01-22-M03 (update)
  • GUSELKUMAB
  • Treatment of chronic idiopathic arthritis (inc. rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and juvenile idiopathic arthritis).
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100099-PIP01-21-M06 (update)
  • BRIVARACETAM
  • Treatment of paediatric epilepsy syndromes
  • Treatment of neonatal seizures.
  • Briviact
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101521-PIP01-24-M01 (update)
  • Derivative of 6-(piperidine-1-carbonyl)pyridin-3-ol
  • Treatment of glomerulonephritis and nephrotic syndrome
  • Uro-Nephrology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101189-PIP01-23-M01 (update)
  • Zasocitinib
  • Treatment of psoriasis
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100230-PIP01-21 -M02 (update)
  • Nerandomilast
  • Treatment of fibrosing interstitial lung disease
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102037-PIP01-25
  • Coramitug
  • Treatment of transthyretin amyloidosis
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100258-PIP01-21-M03 (update)
  • Clesrovimab
  • Prevention of lower respiratory tract infection caused by respiratory syncytial virus
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100046-PIP01-21-M06 (update)
  • cenobamate
  • Treatment of epilepsy
  • Ontozry
  • Ontozry
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102228-PIP01-25
  • Opevesostat tosilate
  • Treatment of Ovarian cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102203-PIP01-25
  • Opevesostat tosilate
  • Treatment of breast cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102191-PIP01-25
  • Opevesostat tosilate
  • Treatment of endometrial cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102041-PIP01-25
  • Daraxonrasib
  • Treatment of pancreatic cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101643-PIP01-24
  • Trivalent mRNA vaccine encoding for NoV VP1 (mRNA-1403)
  • Prevention of acute norovirus gastroenteritis.
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101413-PIP01-24-M01 (update)
  • BLINATUMOMAB
  • Treatment of acute lymphoblastic leukaemia
  • BLINCYTO
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102029-PIP01-25
  • Encaleret
  • Treatment of hypoparathyroidism
  • Endocrinology-Gynaecology-Fertility-metabolism
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100901-PIP01-23-M03 (update)
  • CABOTEGRAVIR
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • Vocabria
  • Vocabria
  • Vocabria
  • Vocabria / Cabenuva
  • Vocabria
  • Vocabria
  • Vocabria
  • Vocabria
  • Vocabria
  • Vocabria / Cabenuva
  • Vocabria / Cabenuva
  • Vocabria
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100594-PIP02-22
  • Azetukalner
  • Treatment of primary generalised tonic-clonic seizures
  • Treatment of epilepsy syndromes
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101618-PIP01-24-M02 (update)
  • ADRENALINE
  • Treatment of allergic reactions
  • EURneffy 2 mg nasal spray, solution in single-dose container
  • EURneffy 2 mg nasal spray, solution in single-dose container
  • EURneffy 2 mg nasal spray, solution in single-dose container
  • NEFFY
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102141-PIP01-25
  • Nanvuranlat
  • Treatment of biliary tract cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No