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PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check Sort descending	Date Published
MHRA-100335-PIP01-21	erdafitinib	Malignant neoplasms (except urothelial carcinoma, haematopoietic and lymphoid tissue)	BALVERSA BALVERSA ERFANDEL BALVERSA	Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	27/09/2022
MHRA-100382-PIP01-21	RAVULIZUMAB	Treatment of myasthenia gravis	Ultomiris Ultomiris Ultomiris Ultomiris	Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	27/09/2022
MHRA-100374-PIP01-21	Adeno-associated virus serotype 1 vector containing the human progranulin GRN gene	Treatment of frontotemporal dementia		Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No	27/09/2022
MHRA-100332-PIP01-21	sotatercept	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	27/09/2022
MHRA-100454-PIP01-22	adagrasib	Treatment of all solid and haematological malignancies		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	27/09/2022
MHRA-100473-PIP01-22	Recombinant COVID-19 subunit nanoparticle	Prevention of coronavirus disease 2019 (COVID-19)	not available at present	Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	27/09/2022
MHRA-100487-PIP01-22	exebacase	Treatment of Staphylococcus aureus bacteraemia		Infectious diseases	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	27/09/2022
MHRA-100162-PIP01-21-M01 (update)	SELEXIPAG	Treatment of pulmonary arterial hypertension (PAH)	Uptravi Uptravi Uptravi	Other: Pulmonary heart disease and diseases of pulmonary circulation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	27/09/2022
MHRA-100158-PIP01-21-M01 (update)	PEMBROLIZUMAB	Treatment of Hodgkin lymphoma	Keytruda Keytruda	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	27/09/2022
MHRA-100240-PIP01-21-M01 (update)	BOSUTINIB	Treatment of chronic myeloid leukaemia (CML)	Bosulif Bosulif	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	27/09/2022
MHRA-100258-PIP01-21-M01 (update)	Fully human IgG1 RB-1 YTE anti-RSV F monoclonal antibody (MK-1654)	Prevention of lower respiratory tract infection caused by respiratory syncytial virus	Not available yet	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	27/09/2022
MHRA-100238-PIP01-21-M01 (update)	AVELUMAB	Treatment of malignant neoplasms of the CNS, lymphoid tissue and other malignant neoplasms.	Bavencio Bavencio Bavencio Bavencio Bavencio	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	27/09/2022
MHRA-100260-PIP01-21-M01 (update)	CEMIPLIMAB	Treatment of all malignant neoplasms (except haematopoietic and lymphoid tissue)	Libtayo Libtayo	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	27/09/2022
MHRA-100182-PIP01-21-M01 (update)	Avalglucosidase alfa	Treatment of Pompe disease		Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	27/09/2022
MHRA-100233-PIP01-21-M01 (update)	CABOZANTINIB	Treatment of malignant solid tumours	Cabometyx Cometriq Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Aptimetyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cometriq Cabometyx Cometriq Cabometyx	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	27/09/2022
MHRA-100249-PIP01-21-M01 (update)	BUDESONIDE GLYCOPYRRONIUM BROMIDE FORMOTEROL FUMARATE DIHYDRATE	Treatment of asthma		Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	27/09/2022
MHRA-100341-PIP01-21-M01 (update)	ISAVUCONAZONIUM SULFATE	Treatment of invasive aspergillosis Treatment of mucormycosis	Cresemba Cresemba Cresemba	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	27/09/2022
MHRA-100328-PIP01-21-M01 (update)	METRELEPTIN	Treatment of lipodystrophy	Myalepta Powder for Solution for Injection Myalepta Myalepta	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	27/09/2022
MHRA-100370-PIP01-21-M01 (update)	EX VIVO EXPANDED AUTOLOGOUS HUMAN CORNEAL EPITHELIAL CELLS CONTAINING STEM CELLS	Treatment of limbal stem cell deficiency due to ocular burns	Holoclar Holoclar Holoclar	Ophthamology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	27/09/2022
MHRA-100377-PIP01-21-M01 (update)	ACALABRUTINIB	Treatment of mature B cell neoplasms	calquence calquence	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	27/09/2022

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