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PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Date Published Sort ascending
MHRA-100130-PIP01-21-M01 (update)	BUPIVACAINE	Postsurgical analgesia	EXPAREL liposomal EXPAREL EXPAREL EXPAREL EXPAREL EXPAREL EXPAREL	Pain	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	29/07/2022
MHRA-100058-PIP01-21-M01 (update)	romosozumab	Treatment of osteoporosis	EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	29/07/2022
MHRA-100046-PIP01-21-M02 (update)	cenobamate	Treatment of epilepsy	Ontozry Ontozry Xcopri	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	29/07/2022
MHRA-100037-PIP01-21-M01 (update)	ponesimod	Treatment of Multiple Sclerosis	Ponvory	Neurology Other: Autoimmune disease/disfunction	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	29/07/2022
MHRA-100224-PIP01-21	Etrasimod L-arginine	Treatment of ulcerative colitis	Not available at present	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	29/07/2022
MHRA-100195-PIP01-21-M01 (update)	BALOXAVIR MARBOXIL	Treatment of Influenza Prevention of Influenza	Xofluza Xofluza Xofluza Xofluza Xofluza	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	18/05/2022
MHRA-100426-PIP01-22-M01 (update)	ligelizumab	Treatment of chronic spontaneous urticaria		Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	17/05/2022
MHRA-100342-PIP01-21-M01 (update)	arimoclomol citrate	Treatment of Niemann-Pick Disease, type C	MIPLYFFA	Neurology	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-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-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-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-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-100207-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.	No	17/05/2022
MHRA-100205-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.	No	17/05/2022
MHRA-100167-PIP01-21-M01 (update)	SODIUM ZIRCONIUM CYCLOSILICATE	Treatment of hyperkalaemia	Lokelma Lokelma Lokelma Lokelma	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	17/05/2022
MHRA-100137-PIP01-21-M01 (update)	linaclotide	Treatment of functional constipation	Constella	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	17/05/2022
MHRA-100116-PIP01-21-M01 (update)	TEZACAFTOR ELEXACAFTOR IVACAFTOR	Treatment of Cystic Fibrosis	Kaftrio Kaftrio Trikafta Kaftrio Trikafta Trikafta Trikafta Kaftrio	Pneumology - Allergology Other: Congenital, hereditary and neonatal diseases and abnormalities	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	17/05/2022
MHRA-100108-PIP01-21-M01 (update)	BRIVARACETAM	Treatment of epilepsy with partial onset seizures.	Briviact Briviact Briviact Briviact Briviact BRIVLERA BRIVLERA Briviact Briviact	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	17/05/2022
MHRA-100099-PIP01-21-M01 (update)	BRIVARACETAM	Treatment of paediatric epilepsy syndromes Treatment of neonatal seizures	Briviact	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	17/05/2022

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