Displaying 181 - 200 of 692
PIPS Search Results
PIP Number Active Substance Sort descending Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-100271-PIP01-21-M01 (update)
  • LINAGLIPTIN
  • Treatment of Type 2 Diabetes Mellitus
  • Trajenta
  • Trajenta
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 02/02/2023
MHRA-100213-PIP01-21-M01 (update)
  • RAVULIZUMAB
  • Treatment of Paroxysmal Nocturnal Haemoglobinuria
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 17/05/2022
MHRA-100214-PIP01-21-M01 (update)
  • RAVULIZUMAB
  • Treatment of atypical Haemolytic Uremic Syndrome
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Uro-Nephrology
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 17/05/2022
MHRA-100382-PIP01-21
  • RAVULIZUMAB
  • Treatment of myasthenia gravis
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 27/09/2022
MHRA-100445-PIP01-22
  • RAVULIZUMAB
  • Treatment of Neuromyelitis Optica Spectrum Disorder
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes 07/12/2022
MHRA-100213-PIP01-21-M03 (update)
  • RAVULIZUMAB
  • Treatment of paroxysmal nocturnal haemoglobinuria (PNH)
  • Ultomiris
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 25/05/2023
MHRA-100214-PIP01-21-M03 (update)
  • RAVULIZUMAB
  • atypical haemolytic uremic syndrome (aHUS)
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 25/05/2023
MHRA-100216-PIP01-21-M01 (update)
  • TRALOKINUMAB
  • Treatment of atopic dermatitis
  • Adtralza
  • Adtralaza
  • Adtralza
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/05/2022
MHRA-100216-PIP01-21-M02 (update)
  • TRALOKINUMAB
  • Treatment of atopic dermatitis
  • Adtralza
  • Adtralza
  • Adtralza
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100217-PIP01-21-M01 (update)
  • ERIBULIN
  • Treatment of soft tissue sarcoma
  • Halaven
  • Halaven
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted 17/05/2022
MHRA-100229-PIP01-21-M01 (update)
  • NINTEDANIB
  • Treatment of fibrosing Interstitial Lung Diseases (ILD)
  • Ofev
  • Vargatef
  • Ofev
  • Vargatef
  • Pneumology - Allergology
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/05/2022
MHRA-100247-PIP01-21-M01 (update)
  • BEROTRALSTAT DIHYDROCHLORIDE
  • Treatment of hereditary angioedema
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/05/2022
MHRA-100248-PIP01-21-M01 (update)
  • RISDIPLAM
  • Treatment of spinal muscular atrophy
  • Evrysdi
  • Evrysdi
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 17/05/2022
MHRA-100717-PIP01-22-M01 (update)
  • RISDIPLAM
  • Treatment of spinal muscular atrophy
  • Evrysdi
  • Evrysdi
  • Evrysdi
  • Evrysdi
  • Evrysdi
  • Evrysdi
  • Evrysdi
  • Evrysdi
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100262-PIP01-21-M01 (update)
  • DALBAVANCIN HYDROCHLORIDE
  • Treatment of acute bacterial skin and skin structure infections (ABSSSI)
  • Xydalba
  • Xydalba
  • Dalvance
  • Xydalba
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 17/05/2022
MHRA-100264-PIP01-21-M01 (update)
  • spesolimab
  • Treatment of Generalised Pustular Psoriasis
  • Prevention of Generalised Pustular Psoriasis
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/05/2022
MHRA-100320-PIP01-21-M01 (update)
  • REMDESIVIR
  • Treatment of coronavirus disease 2019 (COVID-19)
  • VEKLURY
  • VEKLURY
  • VEKLURY
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/05/2022
MHRA-100604-PIP01-22-M01 (update)
  • REMDESIVIR
  • Treatment of coronavirus disease 2019 (COVID-19)
  • VEKLURY
  • VEKLURY
  • VEKLURY
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 02/02/2023
MHRA-100327-PIP01-21-M01 (update)
  • SELPERCATINIB
  • Treatment of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms).
  • Retsevmo
  • Retsevmo
  • Retevmo
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 17/05/2022
MHRA-100327-PIP01-21-M02 (update)
  • SELPERCATINIB
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms).
  • Retsevmo
  • Retsevmo
  • Retevmo
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023