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PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check Sort descending	Compliance outcome	Date Published
MHRA-100065-PIP01-21-M01 (update)	TICAGRELOR	Prevention of thromboembolic events	Brilique Brilique Brilique Brilique	Cardiovascular Diseases Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	03/11/2021
MHRA-100064-PIP01-21-M01 (update)	Neisseria meningitidis serogroup A polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis serogroup C polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis serogroup W-135 polysaccharide conjugated to tetanus toxoid and Neisseria meningitidis serogroup Y polysaccharide conjugated to tetanus toxoid	Prevention of invasive meningococcal disease	MenQuadfi MenQuadfi	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		03/11/2021
MHRA-100046-PIP01-21-M01 (update)	cenobamate	Treatment of epilepsy	ONTORZY Xcopri	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	03/11/2021
MHRA-100039-PIP01-21-M01 (update)	Cotadutide	Treatment of non-alcoholic steatohepatitis (NASH)		Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	17/12/2021
MHRA-100203-PIP01-21-M01 (update)	Avacopan	Treatment of antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis	Tavneos	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	17/12/2021
MHRA-100147-PIP01-21-M01 (update)	OSELTAMIVIR PHOSPHATE	Treatment and prevention of influenza	Tamiflu Tamiflu Tamiflu	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		18/03/2022
MHRA-100157-PIP01-21-M01 (update)	EXENATIDE	Type 2 diabetes mellitus	Byetta Bydureon Bydureon BCise Byetta Byetta Bydureon Bydureon Byetta Bydureon	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	18/03/2022
MHRA-100049-PIP01-21-M02 (update)	IBRUTINIB	Treatment of mature B-cell neoplasm	Imbruvica Imbruvica Imbruvica Imbruvica Imbruvica Imbruvica Imbruvica Imbruvica Imbruvica Imbruvica Imbruvica Imbruvica Imbruvica Imbruvica Imbruvica	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	17/05/2022
MHRA-100213-PIP01-21-M01 (update)	RAVULIZUMAB	Treatment of Paroxysmal Nocturnal Haemoglobinuria	Ultomiris Ultomiris Ultomiris Ultomiris	Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	17/05/2022
MHRA-100214-PIP01-21-M01 (update)	RAVULIZUMAB	Treatment of atypical Haemolytic Uremic Syndrome	Ultomiris Ultomiris Ultomiris Ultomiris Ultomiris Ultomiris Ultomiris Ultomiris Ultomiris Ultomiris	Uro-Nephrology Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	17/05/2022
MHRA-100217-PIP01-21-M01 (update)	ERIBULIN	Treatment of soft tissue sarcoma	Halaven Halaven	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	17/05/2022
MHRA-100248-PIP01-21-M01 (update)	RISDIPLAM	Treatment of spinal muscular atrophy	Evrysdi Evrysdi	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	17/05/2022
MHRA-100262-PIP01-21-M01 (update)	DALBAVANCIN HYDROCHLORIDE	Treatment of acute bacterial skin and skin structure infections (ABSSSI)	Xydalba Xydalba Dalvance Xydalba	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	17/05/2022
MHRA-100327-PIP01-21-M01 (update)	SELPERCATINIB	Treatment of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms).	Retsevmo Retsevmo Retevmo	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	17/05/2022
MHRA-100412-PIP01-22-M01 (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.	Yes	Partial Compliance Check Granted	17/05/2022
MHRA-100129-PIP01-21-M01 (update)	Cipaglucosidase alfa	Treatment of glycogen storage disease Type II (Pompe's disease)	Pombiliti	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		29/07/2022
MHRA-100175-PIP01-21-M01 (update)	AGOMELATINE	Treatment of major depressive episodes	Valdoxan Valdoxan	Psychiatry	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		29/07/2022
MHRA-100237-PIP01-21-M01 (update)	Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain Split influenza virus, inactivated containing antigens equivalent to the A/H3N2-like strain Split influenza virus, inactivated containing antigens equivalent to the B-like strain (Victoria lineage) Split influenza virus, inactivated containing antigens equivalent to the B-like strain (Yamagata lineage)	Prevention of influenza infection	Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain Quadrivalent Influenza Vaccine (Split Virion, Inactivated) High-Dose (called Efluelda throughout rest of Europe) Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Quadrivalent Influenza Vaccine (Split Virion, Inactivated) High Dose	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		29/07/2022
MHRA-100450-PIP01-22-M01 (update)	ALPELISIB	PIK3CA Related Overgrowth Spectrum (PROS)	Piqray Piqray	Other: Congenital, Hereditary, Neonatal Disease and Abnormalities	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	29/07/2022
MHRA-100521-PIP01-22-M01 (update)	Evinacumab	Treatment of elevated cholesterol	Evkeeza Evkeeza Evkeeza	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	29/07/2022

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