Displaying 101 - 120 of 1021
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-102138-PIP01-25
  • 3-(1-(2-((S)-2-(3-Cyclopropyl-4-fluorophenyl)-3-(3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl)-4-methyl-4,5,6,7-tetrahydro-2H-pyrazolo[4,3-c]pyridine-5-carbonyl)-7-((S)-2,2-dimethyltetrahydro-2Hpyran-4-yl)indolizin-3-yl)cyclopropyl)-1,2,4-oxadiazol-5(4H)-one
  • (AZD5004)
  • Treatment of Type 2 Diabetes Mellitus
  • Endocrinology-Gynaecology-Fertility-metabolism
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-102069-PIP01-25
  • acetyl-L-leucine ((s)-(acetylamino)-4-methylpentanoic acid)
  • Treatment of ataxia telangiectasia
  • T.b.d.
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100224-PIP01-21-M03 (update)
  • Etrasimod L-arginine
  • Treatment of ulcerative colitis
  • Velsipity
  • Velsipity
  • Velsipity
  • Velsipity
  • Velsipity
  • Velsipity
  • Velsipity
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100525-PIP02-25
  • TILDRAKIZUMAB
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, ankylosing spondylarthritis, psoriatic arthritis, juvenile idiopathic arthritis)
  • Ilumetri
  • Ilumetri
  • Ilumetri
  • Ilumetri
  • Ilumetri
  • Ilumetri
  • Ilumetri
  • Ilumetri
  • Ilumetri
  • Ilumetri
  • Ilumetri
  • ILUMYA
  • Ilumetri
  • Ilumetri
  • ILUMYA
  • Ilumetri
  • Immunology -Rheumatology-Transplantation
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101698-PIP01-24
  • NNC0487-0111
  • Treatment of obesity
  • Endocrinology-Gynaecology-Fertility-metabolism
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101931-PIP01-25
  • bitopertin
  • Treatment of erythropoietic protoporphyria
  • Treatment of X-linked protoporphyria
  • Not available at present
  • Haematology-Hemostaseology
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100135-PIP03-25
  • frexalimab
  • Treatment of Multiple Sclerosis
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100266-PIP01-21-M01 (update)
  • EXAGAMGLOGENE AUTOTEMCEL
  • Treatment of sickle cell disease
  • Casgevy
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100267-PIP01-21-M01 (update)
  • EXAGAMGLOGENE AUTOTEMCEL
  • Treatment of beta-thalassemia intermedia and major
  • Casgevy
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-101098-PIP01-23-M01 (update)
  • Remibrutinib
  • Treatment of Multiple Sclerosis
  • Neurology
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102111-PIP01-25
  • Remibrutinib
  • Treatment of myasthenia gravis
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101861-PIP01-25
  • Axatilimab
  • Treatment of chronic graft-versus-host disease
  • NIKTIMVO
  • Immunology -Rheumatology-Transplantation
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100897-PIP01-23-M02 (update)
  • Nemolizumab
  • Treatment of atopic dermatitis
  • Nemluvio
  • Nemluvio
  • Nemluvio
  • Nemluvio
  • Nemluvio
  • Nemluvio
  • Nemluvio
  • Nemluvio
  • Nemluvio
  • Nemluvio
  • Nemluvio
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102238-PIP01-25-M01 (update)
  • ozanimod hydrochloride
  • Treatment of ulcerative colitis
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100654-PIP01-22 -M01 (update)
  • triheptanoin
  • Treatment of long-chain fatty acid oxidation disorders (LC-FAOD)
  • Dojolvi
  • Dojolvi
  • Dojolvi
  • Dojolvi
  • Dojolvi
  • Dojolvi
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102316-PIP01-26-M01 (update)
  • ERAVACYCLINE
  • Treatment of complicated intra-abdominal infection
  • Xerava
  • Xerava
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100718-PIP01-22-M03 (update)
  • deucravacitinib
  • Treatment of psoriasis
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102115-PIP01-25
  • Olomorasib
  • Treatment of all conditions included in the category of malignant neoplasms (except nervous system, haematopoietic and lymphoid tissue neoplasms)
  • Treatment of malignant neoplasms of the central nervous system
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102216-PIP01-25
  • bimekizumab
  • Treatment of Palmoplantar Pustulosis
  • Bimzelx
  • Bimzelx
  • Bimzelx
  • Bimzelx
  • Dermatology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100931-PIP01-23-M05 (update)
  • mirikizumab
  • Treatment of ulcerative colitis. Treatment of Crohn's Disease.
  • Omvoh
  • Omvoh
  • Omvoh
  • Omvoh
  • Omvoh
  • Omvoh
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No