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PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Compliance outcome	Date Published Sort ascending
MHRA-100383-PIP01-21	TRASTUZUMAB DERUXTECAN	Treatment of lung cancer	Enhertu Enhertu Enhertu	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	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-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-100447-PIP01-22-M01 (update)	tirzepatide	Treatment of Type 2 Diabetes Mellitus	Not available at present	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	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-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-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-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-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-100340-PIP01-21-M01 (update)	LANADELUMAB	Prevention of hereditary angioedema attacks	TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO	Other: Genetic disease	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		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-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-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-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-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-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-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-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-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-100401-PIP01-21	Humanised IgG2k Fc-modified bispecific antibody against CD3 and BCMA (PF-06863135)	Treatment of multiple myeloma		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		07/12/2022

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