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PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check Sort descending	Date Published
MHRA-100092-PIP01-21-M02 (update)	VENETOCLAX	Treatment of malignant neoplasms of the haematopoietic and lymphoid tissue Treatment of solid malignant tumours	Venclyxto Vencylxto Venclyxto Venclyxto Venclyxto Venclyxto Venclyxto Venclyxto	Haematology-Hemostaseology Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/11/2022
MHRA-100078-PIP01-21-M02 (update)	AVIBACTAM AZTREONAM	Treatment of infections caused by aerobic gram-negative bacteria		Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	07/12/2022
MHRA-100187-PIP01-21-M01 (update)	VONICOG ALFA	Treatment of von Willebrand Disease		Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	07/12/2022
MHRA-100211-PIP01-21-M01 (update)	VOLANESORSEN SODIUM	Treatment of familial chylomicronemia syndrome	WAYLIVRA WAYLIVRA	Gastroenterology-Hepatology Cardiovascular Diseases Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	07/12/2022
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-100288-PIP01-21-M01 (update)	DENOSUMAB	Treatment of osteoporosis	Prolia Prolia Prolia Prolia XGEVA XGEVA XGEVA XGEVA	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	07/12/2022
MHRA-100296-PIP01-21-M01 (update)	palovarotene	Treatment of fibrodysplasia ossificans progressiva	SOHONOS	Other: Musculo-skeletal	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	07/12/2022
MHRA-100323-PIP01-21-M01 (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.	No	07/12/2022
MHRA-100302-PIP01-21-M01 (update)	CRIZANLIZUMAB	Treatment of sickle cell disease	Adakveo® 10 mg/ml concentrate for solution for infusion	Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	07/12/2022
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.	No	07/12/2022
MHRA-100333-PIP01-21-M01 (update)	MIRABEGRON	Treatment of neurogenic detrusor overactivity	BETMIGA BETMIGA MYRBETRIQ / MYRBETRIQ GRANULES	Uro-Nephrology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	07/12/2022
MHRA-100361-PIP01-21-M01 (update)	GOLIMUMAB	Treatment of ulcerative colitis	Simponi 50 mg solution for injection in pre-filled pen Simponi 50 mg solution for injection in pre-filled syringe Simponi 100 mg solution for injection in pre-filled pen Simponi 45 mg/0.45 mL solution for injection in pre-filled pen Simponi Simponi Simponi Simponi Simponi Simponi Simponi Simponi	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	07/12/2022
MHRA-100408-PIP01-21-M01 (update)	Hepatitis B (rDNA) surface antigen adjuvanted	Prevention of hepatitis B virus infection	HEPLISAV B	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	07/12/2022
MHRA-100412-PIP01-22-M02 (update)	vadadustat	Treatment of anaemia due to chronic disorders	VAFSEO VAFSEO	Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	07/12/2022
MHRA-100441-PIP01-22-M01 (update)	Delandistrogene moxeparvovec	Treatment of Duchenne Muscular Dystrophy (DMD)	Elevidys	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	07/12/2022
MHRA-100444-PIP01-22-M01 (update)	ETELCALCETIDE	Treatment of hyperparathyroidism	Parsabiv Parsabiv	Uro-Nephrology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	07/12/2022
MHRA-100455-PIP01-22-M01 (update)	IXAZOMIB	Treatment of multiple myeloma Treatment of lymphoid malignancies (excluding multiple myeloma)	Ninlaro Ninlaro Ninlaro Ninlaro	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	07/12/2022
MHRA-100465-PIP01-22-M01 (update)	efanesoctocog alfa	Treatment of congenital haemophilia A		Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	07/12/2022
MHRA-100492-PIP01-22-M01 (update)	MOLGRAMOSTIM	Treatment of pulmonary alveolar proteinosis	Not available at present	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	07/12/2022
MHRA-100507-PIP01-22-M01 (update)	BREXPIPRAZOLE	Treatment of schizophrenia	RXULTI RXULTI	Psychiatry	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	07/12/2022

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