Displaying 521 - 540 of 891
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-100669-PIP01-22-M02 (update)
  • RILPIVIRINE
  • EMTRICITABINE
  • TENOFOVIR ALAFENAMIDE
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • Odefsey
  • Odefsey
  • Odefsey
  • Infectious diseases
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100512-PIP01-22-M01 (update)
  • DAPAGLIFLOZIN
  • Treatment of Type 1 Diabetes Mellitus
  • Forxiga
  • Forxiga
  • Endocrinology-Gynaecology-Fertility-metabolism
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100547-PIP01-22-M02 (update)
  • PEGINTERFERON BETA-1A
  • Treatment of multiple sclerosis.
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100276-PIP01-21-M03 (update)
  • BRODALUMAB
  • Treatment of psoriasis
  • Kyntheum
  • Kyntheum
  • Lumicef
  • Siliq
  • Kyntheum
  • Kyntheum
  • Kyntheum
  • Dermatology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100117-PIP01-21-M03 (update)
  • ISATUXIMAB
  • Treatment of malignant neoplasms of the haematopoietic and lymphoid tissue
  • Sarclisa
  • Sarclisa
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-100950-PIP01-23
  • lutetium-177 (177Lu) rhPSMA 10.1
  • Treatment of prostate cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100872-PIP01-23
  • pudexacianinium chloride
  • Visualisation of ureter
  • Uro-Nephrology
  • Gastroenterology-Hepatology
  • Diagnostic
  • Endocrinology-Gynaecology-Fertility-metabolism
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101058-PIP01-23
  • SIROLIMUS
  • Treatment of Tuberous Sclerosis
  • Pascomer
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted
MHRA-100866-PIP01-23
  • obecabtagene autoleucel
  • Treatment of acute lymphoblastic leukaemia (ALL)
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100593-PIP01-22
  • aticaprant
  • Treatment of Major Depressive Disorder
  • Not available at present
  • Psychiatry
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101024-PIP01-23-M01 (update)
  • gadoquatrane
  • Diagnosis by evaluation of any known or suspected clinical condition with contrast enhanced magnetic resonance imaging
  • Diagnostic
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100162-PIP01-21-M02 (update)
  • SELEXIPAG
  • Treatment of pulmonary arterial hypertension (PAH)
  • Uptravi
  • Uptravi
  • Uptravi
  • Other: Pulmonary heart disease and diseases of pulmonary circulation
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100932-PIP01-23-M02 (update)
  • Defatted powder of peanuts
  • Treatment of peanut allergy
  • Palforzia
  • Palforzia
  • Palforzia
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100188-PIP01-21-M02 (update)
  • lebrikizumab
  • treatment of atopic dermatitis
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101028-PIP01-23-M01 (update)
  • Cholera vaccine, recombinant, live, oral (strain CVD 103-HgR)
  • Prevention of cholera
  • Vaxchora
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100642-PIP01-22-M02 (update)
  • Tremelimumab
  • Treatment of all conditions included in the category of malignant neoplasms (except central nervous system, haematopoietic and lymphoid tissue).
  • IMJUDO
  • Tremelimumab AstraZeneca
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100141-PIP01-21-M01 (update)
  • BENRALIZUMAB
  • Treatment of Eosinophilic granulomatosis with polyangiitis (EGPA)
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA PEN
  • FASENRA
  • FASENRA PEN
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101188-PIP01-23-M01 (update)
  • fosdenopterin
  • Treatment of patients with molybdenum cofactor deficiency (MoCD) Type A
  • Nulibry
  • Other: Other alimentary tract and metabolism products, Various alimentary tract and metabolism products
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101071-PIP01-23-M01 (update)
  • pegzilarginase
  • Treatment of hyperargininaemia
  • Loargys
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100606-PIP01-22-M01 (update)
  • sparsentan
  • Treatment of focal segmental glomerulosclerosis
  • Filspari
  • Filspari
  • Uro-Nephrology
PM: decision on the application for modification of an agreed paediatric investigation plan. No