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Displaying 761 - 773 of 773

PIPS Search Results
PIP Number	Active Substance Sort descending	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Compliance outcome	Date Published
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-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-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-100372-PIP01-21-M01 (update)	concizumab	Treatment of congenital haemophilia A Treatment of congenital haemophilia B	Alhemo Alhemo	Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024
MHRA-101162-PIP01-23-M01 (update)	LETERMOVIR	Prevention of cytomegalovirus infection	PREVYMIS PREVYMIS PREVYMIS PREVYMIS PREVYMIS PREVYMIS PREVYMIS PRVEYMIS PREVYMIS PREVYMIS PREVYMIS PREVYMIS PREVYMIS PREVYMIS PREVYMIS PREVYMIS PREVYMIS PREVYMIS PREVYMIS PREVYMIS PREVYMIS PREVYMIS PREVYMIS PREVYMIS PREVYMIS tablet PREVYMIS	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	30/04/2024
MHRA-101249-PIP01-23-M01 (update)	Tovorafenib	Treatment of paediatric low grade glioma		Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		01/05/2024
MHRA-101304-PIP01-23-M01 (update)	FILGOTINIB MALEATE	Treatment of ulcerative colitis	Jyseleca Jyseleca Jyseleca Jyseleca Jyseleca	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		01/05/2024
MHRA-100173-PIP01-21	PACLITAXEL	Treatment of soft tissue sarcoma	Paxorlea	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		17/11/2021

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