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PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Date Published Sort ascending
MHRA-100432-PIP01-22	2-Amino-N-(4-hydroxybicyclo[2.2.2]octan-1-yl)-5-(4-((1R,5S)-3- (tetrahydro-2H-pyran-4-yl)-3-azabicyclo[3.1.0]hexan-1- yl)phenyl)nicotinamide fumarate dihydrate	Treatment of fibrodysplasia ossificans progressiva		Endocrinology-Gynaecology-Fertility-metabolism	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	07/12/2022
MHRA-100445-PIP01-22	RAVULIZUMAB	Treatment of Neuromyelitis Optica Spectrum Disorder	Ultomiris Ultomiris Ultomiris Ultomiris	Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	Yes	07/12/2022
MHRA-100030-PIP01-21	9-valent vaccine consisting of the O-antigen polysaccharides of the extraintestinal pathogenic Escherichia coli (ExPEC) serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B and O75 bioconjugated to the carrier exoprotein A (EPA), a genetically detoxified protein from Pseudomonas aeruginosa (ExPEC9V)	Prevention of infections caused by extraintestinal pathogenic Escherichia coli (ExPEC)		Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	07/12/2022
MHRA-100273-PIP01-21	5-Ethoxy-1-(6-(3-methyl-2-((5-methyl-2-(tetrahydro-2Hpyran- 4-yl)-1,2,3,4-tetrahydroisoquinolin-6- yl)methoxy)phenyl)pyridin-2-yl)-1H-pyrazole-4- carboxylic acid	Treatment of Chronic Kidney Disease		Uro-Nephrology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	07/12/2022
MHRA-100398-PIP01-21	ralmitaront	Treatment of schizophrenia		Psychiatry	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	07/12/2022
MHRA-100403-PIP01-21	Fusion protein composed of the first 2 immunoglobulin (Ig)-like domains of the human ROBO2 fused to human IgG1 Fc (PF-06730512)	Treatment of focal segmental glomerulosclerosis	Not available at present	Uro-Nephrology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	07/12/2022
MHRA-100257-PIP01-21	2-[(4-{6-[(4-cyano-2-fluorobenzyl)oxy]pyridin-2-yl}piperidin-1-yl)methyl]-1-[(2S)-oxetan-2-ylmethyl]-1H-benzimidazole-6-carboxylic acid tris(hydroxymethyl)aminomethane salt (1:1) PF-06882961	Treatment of Type 2 Diabetes Mellitus	Not available at present	Endocrinology-Gynaecology-Fertility-metabolism	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	07/12/2022
MHRA-100253-PIP01-21	Zuranolone	Treatment of post-partum depression		Psychiatry	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	07/12/2022
MHRA-100242-PIP01-21	Respiratory Syncytial Virus Stabilised Prefusion F Subunit Vaccine (RSVpreF, PF-06928316)	Prevention of lower respiratory tract disease caused by respiratory syncytial virus.		Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	07/12/2022
MHRA-100516-PIP01-22	Toripalimab	Malignant neoplasms (except CNS, haematopoietic and lymphoid tissue and melanoma).	Not available at present TUOYI	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	03/11/2022
MHRA-100480-PIP01-22	(S)-5-amino-3-(4-((5-fluoro-2-methoxybenzamido)methyl)phenyl)-1-(1,1,1-trifluoropropane-2-yl)-1H-pyrazole-4-carboxamide	Treatment of mature B-cell malignancies		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	02/11/2022
MHRA-100386-PIP01-21	patritumab deruxtecan	Treatment of lung cancer		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	02/11/2022
MHRA-100385-PIP01-21	datopotamab deruxtecan	Treatment of breast cancer		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	02/11/2022
MHRA-100384-PIP01-21	datopotamab deruxtecan	Treatment of lung cancer		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	02/11/2022
MHRA-100311-PIP01-21	Cetrelimab	Treatment of urothelial carcinoma		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	02/11/2022
MHRA-100326-PIP01-21	GEMCITABINE HYDROCHLORIDE	Treatment of urothelial carcinoma	Not available at present	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	02/11/2022
MHRA-100246-PIP01-21	MK-1026	Treatment of mature B-cell malignancies		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	02/11/2022
MHRA-100176-PIP01-21	favezelimab PEMBROLIZUMAB	Malignant neoplasms (except CNS, haematopoietic, lymphoid-tissue-& melanoma) Neoplasms of CNS		Oncology	W: decision granting a waiver in all age groups for the listed condition(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
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

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