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PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Date Published Sort ascending
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
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-100317-PIP01-21	Ralinepag	Treatment of pulmonary arterial hypertension		Cardiovascular Diseases	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	07/12/2022
MHRA-100432-PIP01-22	2-Amino-N-(4-hydroxybicyclo[2.2.2]octan-1-yl)-5-(4-((1R,5S)-3- (tetrahydro-2H-pyran-4-yl)-3-azabicyclo[3.1.0]hexan-1- yl)phenyl)nicotinamide fumarate dihydrate	Treatment of fibrodysplasia ossificans progressiva		Endocrinology-Gynaecology-Fertility-metabolism	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	07/12/2022
MHRA-100445-PIP01-22	RAVULIZUMAB	Treatment of Neuromyelitis Optica Spectrum Disorder	Ultomiris Ultomiris Ultomiris Ultomiris	Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	Yes	07/12/2022
MHRA-100030-PIP01-21	9-valent vaccine consisting of the O-antigen polysaccharides of the extraintestinal pathogenic Escherichia coli (ExPEC) serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B and O75 bioconjugated to the carrier exoprotein A (EPA), a genetically detoxified protein from Pseudomonas aeruginosa (ExPEC9V)	Prevention of infections caused by extraintestinal pathogenic Escherichia coli (ExPEC)		Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	07/12/2022
MHRA-100398-PIP01-21	ralmitaront	Treatment of schizophrenia		Psychiatry	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	07/12/2022
MHRA-100403-PIP01-21	Fusion protein composed of the first 2 immunoglobulin (Ig)-like domains of the human ROBO2 fused to human IgG1 Fc (PF-06730512)	Treatment of focal segmental glomerulosclerosis	Not available at present	Uro-Nephrology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	07/12/2022

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