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Displaying 41 - 60 of 199
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-101513-PIP01-24-M02 (update)
  • ERTUGLIFLOZIN L-PYROGLUTAMIC ACID
  • Treatment of Type 2 Diabetes Mellitus
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-100332-PIP01-21-M01 (update)
  • sotatercept
  • Treatment of pulmonary arterial hypertension
  • Not available at present
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
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. Yes Full Compliance Check Granted
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. Yes Full Compliance Check Granted
MHRA-100324-PIP01-21-M01 (update)
  • Loncastuximab tesirine
  • Treatment of mature B-cell neoplasms
  • Zynlonta
  • Zynlonta
  • Zynlonta
  • Zynlonta
  • Zynlonta
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100323-PIP01-21-M02 (update)
  • SAXAGLIPTIN
  • Treatment of Type 2 Diabetes Mellitus
  • Onglyza
  • Onglyza
  • Onglyza
  • Onglyza
  • Onglyza
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100300-PIP01-21-M03 (update)
  • DARUNAVIR
  • COBICISTAT
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100297-PIP01-21-M05 (update)
  • Rocatinlimab
  • Treatment of atopic dermatitis
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100288-PIP01-21-M02 (update)
  • DENOSUMAB
  • Treatment of osteoporosis
  • Prolia
  • Prolia
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100284-PIP01-21-M03 (update)
  • MEXILETINE HYDROCHLORIDE
  • Treatment of myotonic disorders
  • Namuscla
  • Namuscla
  • Other: Muscle disorders
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100283-PIP01-21-M03 (update)
  • USTEKINUMAB
  • Treatment of Crohn's disease
  • Stelara
  • Stelara
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100274-PIP01-21-M02 (update)
  • ELIGLUSTAT
  • Treatment of Gaucher Disease Type 2
  • Treatment of Gaucher Disease Type 1 and Type 3
  • CERDELGA
  • Other: Lysosomal Storage Disorder
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100272-PIP01-21-M01 (update)
  • EMPAGLIFLOZIN
  • Treatment of Type 2 Diabetes Mellitus
  • Jardiance
  • Jardiance
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
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 Full Compliance Check Granted
MHRA-100268-PIP01-21-M03 (update)
  • INOTUZUMAB OZOGAMICIN
  • Treatment of B cell acute lymphoblastic leukaemia
  • Besponsa
  • Besponsa
  • Haematology-Hemostaseology
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100262-PIP01-21-M02 (update)
  • DALBAVANCIN HYDROCHLORIDE
  • Treatment of acute bacterial skin and skin structure infections (ABSSSI)
  • Xydalba
  • Xydalba
  • Xydalba
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100259-PIP01-21-M01 (update)
  • DULAGLUTIDE
  • Treatment of Type 2 Diabetes Mellitus
  • Trulicity
  • Trulicity
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100247-PIP01-21-M02 (update)
  • BEROTRALSTAT DIHYDROCHLORIDE
  • Treatment of hereditary angioedema
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100240-PIP01-21-M04 (update)
  • BOSUTINIB
  • Treatment of chronic myeloid leukemia
  • Bosulif
  • Bosulif
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100235-PIP01-21-M03 (update)
  • Sotrovimab
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Xevudy
  • Xevudy
  • Xevudy
  • Xevudy
  • Xevudy
  • Xevudy
  • Xevudy
  • Xevudy
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted