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Displaying 741 - 760 of 773

PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Compliance outcome	Date Published Sort descending
MHRA-100195-PIP01-21-M04 (update)	BALOXAVIR MARBOXIL	Treatment of Influenza Prevention of Influenza	Xofluxa Xofluza Xofluza Xofluza Xofluza Xofluza Xofluza Xofluza Xofluza Xofluza Xofluza	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		30/04/2024
MHRA-100099-PIP01-21-M04 (update)	BRIVARACETAM	Treatment of paediatric epilepsy syndromes Treatment of neonatal seizures	Briviact (in Italy: Nubriveo)	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024
MHRA-101078-PIP01-23-M01 (update)	OLAPARIB	Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic, and lymphoid tissue).	Lynparza Lynparza Lynparza Lynparza Lynparza Lynparza 100 mg film-coated tablets Lynparza 150 mg film-coated tablets	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024
MHRA-101141-PIP01-23-M01 (update)	mavacamten	Treatment of hypertrophic cardiomyopathy	CAMZYOS CAMZYOS CAMZYOS CAMZYOS CAMZYOS CAMZYOS CAMZYOS CAMZYOS CAMZYOS CAMZYOS CAMZYOS CAMZYOS	Cardiovascular Diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024
MHRA-101293-PIP01-23-M01 (update)	METHOXYFLURANE	Treatment of acute pain	Penthrox	Pain	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	30/04/2024
MHRA-101234-PIP01-23-M01 (update)	ALIROCUMAB	Treatment of elevated cholesterol	Praluent Praluent Praluent Praluent Praluent Praluent Praluent Praluent Praluent Praluent Praluent Praluent Praluent Praluent Praluent	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	30/04/2024
MHRA-100343-PIP01-21-M03 (update)	MACITENTAN	Treatment of pulmonary arterial hypertension Treatment of systemic sclerosis Treatment of idiopathic pulmonary fibrosis.	Opsumit	Cardiovascular Diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		30/04/2024
MHRA-100105-PIP01-21-M01 (update)	ALPRAZOLAM	Treatment of epileptic seizures		Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024
MHRA-100203-PIP01-21-M02 (update)	Avacopan	Antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis	Tavneos	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024
MHRA-100718-PIP01-22-M02 (update)	deucravacitinib	Treatment of psoriasis	SOTYKTU SOTYKTU SOTYKTU SOTYKTU SOTYKTU SOTYKTU SOTYKTU SOTYKTU SOTYKTU SOTYKTU SOTYKTU SOTYKTU SOTYKTU	Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024
MHRA-101027-PIP01-23-M01 (update)	ANIFROLUMAB	Treatment of Systemic Lupus Erythematosus	Saphnelo Saphnelo	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024
MHRA-100916-PIP01-23-M01 (update)	ELUXADOLINE	Treatment of diarrhoea irritable bowel syndrome.	Viberzi Viberzi Viberzi Viberzi Truberzi	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024
MHRA-101123-PIP01-23-M01 (update)	BREXUCABTAGENE AUTOLEUCEL	Treatment of acute lymphoblastic leukaemia	Brexucabtagene autoleucel Brexucabtagene autoleucel Brexucabtagene autoleucel	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024
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		30/04/2024
MHRA-100695-PIP01-22-M04 (update)	Etranacogene dezaparvovec	Treatment of haemophilia B	Hemgenix Hemgenix Hemgenix Hemgenix	Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024
MHRA-100807-PIP01-22-M02 (update)	RIMEGEPANT SULFATE	Treatment of migraine headaches	Vydura Vydura Vydura Vydura Vydura Nurtec ODT Nurtec ODT Nurtec ODT Nurtec ODT	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024
MHRA-100284-PIP01-21-M02 (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.	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-100779-PIP01-22-M02 (update)	GUSELKUMAB	Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and juvenile idiopathic arthritis)	TREMFYA TREMFYA TREMFYA TREMFYA TREMFYA	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024
MHRA-100143-PIP01-21-M02 (update)	TENOFOVIR ALAFENAMIDE FUMARATE	Treatment of chronic viral hepatitis B	Vemlidy Vemlidy Vemlidy	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024

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