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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-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-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-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-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-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-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-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-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-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-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
MHRA-100234-PIP01-21	(S)-N-(1-amino-4-(dimethylamino)-1-oxobutan-2-yl)-5-(2,4-difluorophenoxy)-1-isobutyl-1H-indazole-6-carboxamide	Treatment of dilated cardiomyopathy due to lamin A/C gene mutations		Cardiovascular Diseases	W: decision granting a waiver in all age groups for the listed condition(s).	No	02/11/2022
MHRA-100355-PIP02-22	Fenebrutinib	Treatment of multiple sclerosis		Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	02/11/2022
MHRA-100372-PIP01-21	concizumab	Treatment of congenital haemophilia A Treatment of congenital haemophilia B	Not available at present	Haematology-Hemostaseology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	02/11/2022
MHRA-100470-PIP01-22	Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid carrier protein, Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid carrier protein, Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid carrier protein, Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid carrier protein, Neisseria meningitidis serogroup B fHbp subfamily A, Neisseria meningitidis serogroup B fHbp subfamily B,	Prevention of Invasive disease caused by Neisseria meningitidis group A, B, C, W and Y		Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	02/11/2022
MHRA-100069-PIP01-21	RIBOCICLIB	Treatment of neuroblastoma	KISQALI KISQALI	Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	02/11/2022
MHRA-100239-PIP01-21	multivalent pneumococcal polysaccharide conjugate vaccine	Prevention of disease caused by Streptococcus pneumoniae		Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	02/11/2022
MHRA-100347-PIP01-21	Respiratory Syncytial Virus Stabilised Prefusion F Subunit Vaccine (RSVpreF, PF-06928316)	Prevention of lower respiratory track disease caused by RSV via maternal immunisation.	Not available at present	Vaccines	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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