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PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Date Published Sort ascending
MHRA-100431-PIP01-22	derivative of pyrrolopyrimidine	Prevention of cardiovascular events in patients with heart failure		Cardiovascular Diseases	W: decision granting a waiver in all age groups for the listed condition(s).	No	27/09/2022
MHRA-100185-PIP01-21	Anti-C1s Humanized IgG4 Monoclonal Antibody	Treatment of cold agglutinin disease		Neurology Immunology -Rheumatology-Transplantation Haematology-Hemostaseology	W: decision granting a waiver in all age groups for the listed condition(s).	No	27/09/2022
MHRA-100125-PIP01-21	PEMBROLIZUMAB vibostolimab	Malignant neoplasms (except CNS, haematopoietic, lymphoid tissue melanoma) Malignant CNS neoplasms		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	27/09/2022
MHRA-100136-PIP01-21	PEMBROLIZUMAB quavonlimab	All conditions of malignant neoplasms (except haematopoietic, lymphoid tissue and melanoma).		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	27/09/2022
MHRA-100490-PIP01-22-M01 (update)	nirsevimab (MEDI8897)	Prevention of lower respiratory tract infection caused by respiratory syncytial virus (RSV).	Beyfortus	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	27/09/2022
MHRA-100164-PIP01-21-M01 (update)	Nirmatrelvir RITONAVIR	Treatment of coronavirus disease 2019 (COVID-19) Prevention of coronavirus disease 2019 (COVID-19)	Paxlovid Paxlovid Paxlovid Paxlovid Paxlovid Paxlovid	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	27/09/2022
MHRA-100149-PIP01-21-M01 (update)	NVX-CoV2373	Prevention of coronavirus disease 2019 (COVID-19)	Approved invented name: Nuvaxovid dispersion for injection, Covid-19 Vaccine (recombinant, adjuvanted) Nuvaxovid Nuvaxovid Nuvaxovid (Please note that details provided herein specifically relate to Singapore) Nuvaxovid Nuvaxovid (Please note that details provided herein specifically relate to Singapore) Nuvaxovid Nuvaxovid Nuvaxovid Nuvaxovid Nuvaxovid Nuvaxovid Nuvaxovid Nuvaxovid TBD - Approval not yet granted TBD - Approval not yet granted Nuvaxovid (Note: PLGB registration, applicable to Great Britain only)	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	27/09/2022
MHRA-100352-PIP01-21-M01 (update)	AVAPRITINIB	Treatment of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms)	AYVAKYT AYVAKYT AYVAKYT AYVAKYT	Oncology	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
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-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-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-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-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-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-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-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-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-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-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

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