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Displaying 81 - 100 of 669
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Sort ascending Decision Type Compliance Check Compliance outcome Date Published
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 19/12/2023
MHRA-100225-PIP01-21-M02 (update)
  • PARATHYROID HORMONE
  • Treatment of hypoparathyroidism
  • Natpar
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/01/2024
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 30/01/2024
MHRA-100369-PIP01-21-M02 (update)
  • MIGALASTAT HYDROCHLORIDE
  • Treatment of Fabry disease
  • Galafold 123 mg capsules
  • Galafold
  • Galafold
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/01/2024
MHRA-101270-PIP01-23
  • SEMAGLUTIDE
  • Prevention of cardiovascular events in patients with atherosclerosis
  • Wegovy
  • Wegovy
  • Wegovy
  • Wegovy
  • Wegovy
  • Wegovy
  • Wegovy
  • Wegovy
  • Wegovy
  • Wegovy
  • Wegovy
  • Wegovy
  • Wegovy
  • Wegovy
  • Wegovy
  • Wegovy
  • Wegovy
  • Wegovy
  • Wegovy
  • Wegovy
  • Wegovy
  • Wegovy
  • Wegovy
  • Wegovy
  • Endocrinology-Gynaecology-Fertility-metabolism
W: decision granting a waiver in all age groups for the listed condition(s). No 30/04/2024
MHRA-101232-PIP01-23
  • palopegteriparatide
  • Treatment of hypoparathyroidism
  • Yorvipath
  • Yorvipath
  • Endocrinology-Gynaecology-Fertility-metabolism
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 30/04/2024
MHRA-101044-PIP01-23-M01 (update)
  • INCLISIRAN SODIUM
  • Treatment of elevated cholesterol
  • Leqvio
  • Leqvio
  • Leqvio
  • Leqvio
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-101262-PIP01-23-M01 (update)
  • DIENOGEST
  • ETHINYLESTRADIOL
  • Prevention of pregnancy
  • Not available at present
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-100163-PIP01-21
  • Vupanorsen (PF-07285557)
  • Treatment of Hypertriglyceridemia
  • Prevention of cardiovascular events
  • Not available at present
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No 18/03/2022
MHRA-100183-PIP01-21-M01 (update)
  • AZILSARTAN MEDOXOMIL
  • Treatment of hypertension
  • Edarbi
  • Edarbi
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022
MHRA-100250-PIP01-21-M01 (update)
  • VERICIGUAT
  • Treatment of left ventricular failure
  • Verquvo
  • Verquvo
  • Verquvo
  • Verquvo
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022
MHRA-100308-PIP01-21-M01 (update)
  • AZILSARTAN MEDOXOMIL
  • Treatment of hypertension
  • Edarbi
  • Edarbi
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022
MHRA-100122-PIP01-21
  • olpasiran
  • Prevention of cardiovascular events
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No 29/07/2022
MHRA-100332-PIP01-21
  • sotatercept
  • Treatment of pulmonary arterial hypertension
  • Cardiovascular Diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 27/09/2022
MHRA-100431-PIP01-22
  • derivative of pyrrolopyrimidine
  • Prevention of cardiovascular events in patients with heart failure
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No 27/09/2022
MHRA-100243-PIP01-21
  • DAPAGLIFLOZIN
  • 2-{(3S)-7-fluoro-4-[(3-oxo-3,4-dihydro-2H-1,4-benzoxazin-6-yl)carbonyl]-3,4-dihydro-2H-1,4-benzoxazin-3-yl}-N-methylacetamide (AZD9977)
  • Prevention of cardiovascular events in patients with chronic heart failure
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No 21/10/2022
MHRA-100234-PIP01-21
  • (S)-N-(1-amino-4-(dimethylamino)-1-oxobutan-2-yl)-5-(2,4-difluorophenoxy)-1-isobutyl-1H-indazole-6-carboxamide
  • Treatment of dilated cardiomyopathy due to lamin A/C gene mutations
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No 02/11/2022
MHRA-100343-PIP01-21-M01 (update)
  • MACITENTAN
  • Treatment of pulmonary arterial hypertension
  • systemic sclerosis
  • idiopathic pulmonary fibrosis
  • Opsumit
  • Opsumit
  • Opsumit
  • Opsumit
  • Opsumit
  • Opsumit
  • Opsumit
  • Zependo
  • Opsumit
  • Opsumit
  • Opsumit
  • Opsumit
  • Opsumit
  • Zependo
  • Opsumit
  • Opsumit
  • Opsumit
  • Opsumit
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/11/2022
MHRA-100317-PIP01-21
  • Ralinepag
  • Treatment of pulmonary arterial hypertension
  • Cardiovascular Diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 07/12/2022
MHRA-100329-PIP01-21-M01 (update)
  • EDOXABAN TOSYLATE
  • Treatment of venous thromboembolism
  • Prevention of arterial thromboembolism
  • Prevention of Venous thromboembolism
  • Lixiana film-coated tablets
  • Lixiana
  • Cardiovascular Diseases
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022