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Displaying 421 - 440 of 669
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Sort descending Decision Type Compliance Check Compliance outcome Date Published
MHRA-100645-PIP01-22-M01 (update)
  • AMIKACIN SULFATE
  • Treatment of Pseudomonas aeruginosa lung infection/colonisation in cystic fibrosis patients
  • Treatment of non-tuberculous mycobacterial lung infection
  • Arikayce
  • Arikayce
  • Arikayce liposomal
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100102-PIP01-21-M02 (update)
  • INDACATEROL ACETATE
  • MOMETASONE FUROATE
  • Treatment of asthma
  • Atectura Breezhaler
  • Atectura Breezhaler
  • Atectura Breezhaler
  • Atectura Breezhaler and its duplicate authorization Bemrist Breezhaler
  • Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler
  • Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler
  • Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler
  • Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler
  • Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler
  • Atectura Breezhaler
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/08/2023
MHRA-100933-PIP01-23
  • camlipixant
  • Treatment of unexplained or chronic refractory cough
  • Pneumology - Allergology
W: decision granting a waiver in all age groups for the listed condition(s). No 19/12/2023
MHRA-100894-PIP01-23
  • depemokimab
  • Treatment of Eosinophilic granulomatosis with polyangiitis (EGPA)
  • Pneumology - Allergology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 19/12/2023
MHRA-101019-PIP01-23
  • Treprostinil Palmitil
  • Treatment of pulmonary hypertension due to lung disease and/or hypoxia.
  • Not available at present
  • Pneumology - Allergology
W: decision granting a waiver in all age groups for the listed condition(s). No 19/12/2023
MHRA-100995-PIP01-23
  • LysoPhosphatidic Acid receptor 1 (LPA1) antagonist (BMS-986278)
  • Treatment of fibrosing Interstitial Lung Diseases (ILD)
  • Pneumology - Allergology
W: decision granting a waiver in all age groups for the listed condition(s). No 19/12/2023
MHRA-100249-PIP01-21-M02 (update)
  • BUDESONIDE
  • GLYCOPYRRONIUM BROMIDE
  • FORMOTEROL FUMARATE DIHYDRATE
  • Treatment of asthma
  • Trixeo Aerosphere
  • Trixeo Aerosphere
  • Trixeo Aerosphere
  • BREZTRI AEROSPHERE
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
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 19/12/2023
MHRA-100932-PIP01-23-M01 (update)
  • Peanut Flour
  • Treatment of peanut allergy
  • Palforzia
  • PALFORZIA
  • Palforzia
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100339-PIP01-21
  • Autologous selected renal cells
  • Treatment of Chronic Kidney Disease
  • Not available at present
  • Uro-Nephrology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 04/05/2022
MHRA-100212-PIP01-21-M01 (update)
  • Finerenone
  • Treatment of Chronic Kidney Disease
  • Kerendia
  • Kerendia
  • Uro-Nephrology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022
MHRA-100403-PIP01-21
  • Fusion protein composed of the first 2 immunoglobulin (Ig)-like domains of the human ROBO2 fused to human IgG1 Fc (PF-06730512)
  • Treatment of focal segmental glomerulosclerosis
  • Not available at present
  • Uro-Nephrology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 07/12/2022
MHRA-100273-PIP01-21
  • 5-Ethoxy-1-(6-(3-methyl-2-((5-methyl-2-(tetrahydro-2Hpyran- 4-yl)-1,2,3,4-tetrahydroisoquinolin-6- yl)methoxy)phenyl)pyridin-2-yl)-1H-pyrazole-4- carboxylic acid
  • Treatment of Chronic Kidney Disease
  • Uro-Nephrology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 07/12/2022
MHRA-100333-PIP01-21-M01 (update)
  • MIRABEGRON
  • Treatment of neurogenic detrusor overactivity
  • BETMIGA
  • BETMIGA
  • MYRBETRIQ / MYRBETRIQ GRANULES
  • Uro-Nephrology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100444-PIP01-22-M01 (update)
  • ETELCALCETIDE
  • Treatment of hyperparathyroidism
  • Parsabiv
  • Parsabiv
  • Uro-Nephrology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100566-PIP01-22-M01 (update)
  • MIRABEGRON
  • Treatment of neurogenic detrusor overactivity
  • BETMIGA
  • BETMIGA
  • MYRBETRIQ / MYRBETRIQ GRANULES
  • Uro-Nephrology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100628-PIP01-22
  • Sibeprenlimab
  • Treatment of primary immunoglobulin A nephropathy
  • Uro-Nephrology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 25/05/2023
MHRA-100606-PIP01-22
  • sparsentan
  • Treatment of focal segmental glomerulosclerosis
  • Not available at present
  • Uro-Nephrology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 25/05/2023
MHRA-100646-PIP01-22-M01 (update)
  • TOLVAPTAN
  • Treatment of dilutional hyponatraemia
  • Treatment of polycystic kidney disease
  • Samsca
  • Jinarc
  • Samsca
  • Jinarc
  • Uro-Nephrology
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100212-PIP01-21-M02 (update)
  • FINERENONE
  • Treatment of Chronic Kidney Disease
  • Kerendia
  • Kerendia
  • Uro-Nephrology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/08/2023