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PIPS Search Results
PIP Number	Active Substance Sort descending	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Compliance outcome	Date Published
MHRA-100522-PIP01-22-M01 (update)	CABOZANTINIB	Treatment of malignant solid tumours	Cometriq Cabometyx Cabometyx Cometriq	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	07/12/2022
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-100249-PIP01-21-M02 (update)	BUDESONIDE GLYCOPYRRONIUM BROMIDE FORMOTEROL FUMARATE DIHYDRATE	Treatment of asthma	Trixeo Aerosphere Trixeo Aerosphere Trixeo Aerosphere BREZTRI AEROSPHERE	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
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
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-100352-PIP01-21-M02 (update)	AVAPRITINIB	Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms)	AYVAKYT AYVAKYT AYVAKYT AYVAKYT AYVAKYT AYVAKYT	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
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-100164-PIP01-21-M02 (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		30/06/2023
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-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-100035-PIP01-21	POVIDONE-IODINE ISOPROPYL ALCOHOL	Prevention of infection prior to invasive procedures	PurPrep	Other: Antiseptic	W: decision granting a waiver in all age groups for the listed condition(s).	No		21/10/2022
MHRA-100243-PIP01-21	DAPAGLIFLOZIN 2-{(3S)-7-fluoro-4-[(3-oxo-3,4-dihydro-2H-1,4-benzoxazin-6-yl)carbonyl]-3,4-dihydro-2H-1,4-benzoxazin-3-yl}-N-methylacetamide (AZD9977)	Prevention of cardiovascular events in patients with chronic heart failure		Cardiovascular Diseases	W: decision granting a waiver in all age groups for the listed condition(s).	No		21/10/2022
MHRA-100512-PIP01-22-M01 (update)	DAPAGLIFLOZIN	Treatment of Type 1 Diabetes Mellitus	Forxiga Forxiga	Endocrinology-Gynaecology-Fertility-metabolism	W: decision granting a waiver in all age groups for the listed condition(s).	No		30/01/2024
MHRA-100177-PIP01-21-M01 (update)	INFLUENZA B/YAMAGATA/16/88-LIKE VIRUS ANTIGEN INFLUENZA A/ (H3N2)-LIKE VIRUS ANTIGEN INFLUENZA B/VICTORIA/2/87-LIKE VIRUS ANTIGEN INFLUENZA A/ (H1N1)-LIKE VIRUS ANTIGEN	Prevention of influenza	FLUCELVAX TETRA FLUCELVAX TETRA FLUCELVAX QUADRIVALENT FLUCELVAX QUAD FLUCELVAX QUAD FLUCELVAX QUAD FLUCELVAX QUAD FLUCELVAX TETRA	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		21/10/2022
MHRA-100177-PIP01-21-M02 (update)	INFLUENZA A/ (H1N1)-LIKE VIRUS ANTIGEN INFLUENZA A/ (H3N2)-LIKE VIRUS ANTIGEN INFLUENZA B/VICTORIA/2/87-LIKE VIRUS ANTIGEN INFLUENZA B/YAMAGATA/16/88-LIKE VIRUS ANTIGEN	Prevention of Influenza	FLUCELVAX TETRA Cell-based Quadrivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe FLUCELVAX TETRA	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	24/08/2023
MHRA-100019-PIP01-21	2-(3-(4-(1H-INDAZOL-5-YLAMINO)QUINAZOLIN-2-YL)PHENOXY)-N-ISOPROPYLACETAMIDE-METHANE SULFONIC ACID SALT	Treatment of chronic Graft versus Host Disease (cGVHD)		Immunology -Rheumatology-Transplantation	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		24/10/2022
MHRA-100075-PIP01-21	leniolisib	Treatment of activated phosphoinositide 3-kinase delta syndrome (APDS)	Not available at present	Immunology -Rheumatology-Transplantation	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		02/11/2022

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