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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-100078-PIP01-21-M02 (update)	AVIBACTAM AZTREONAM	Treatment of infections caused by aerobic gram-negative bacteria		Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	07/12/2022
MHRA-100317-PIP01-21	Ralinepag	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	07/12/2022
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-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-100092-PIP01-21-M02 (update)	VENETOCLAX	Treatment of malignant neoplasms of the haematopoietic and lymphoid tissue Treatment of solid malignant tumours	Venclyxto Vencylxto Venclyxto Venclyxto Venclyxto Venclyxto Venclyxto Venclyxto	Haematology-Hemostaseology Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/11/2022
MHRA-100236-PIP01-21-M02 (update)	Pneumococcal Polysaccharide Serotype 6A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 14 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 3 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 12F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 23F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 33F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 5 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 7F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 6B conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 19A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 19F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 8 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 11A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 15B conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 1 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 22F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 4 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 9V conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 10A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 18C conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate	Prevention of disease caused by Streptococcus pneumoniae	Prevnar 20 Apexxnar	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	10/11/2022
MHRA-100236-PIP01-21-M01 (update)	Pneumococcal Polysaccharide Serotype 6A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 14 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 3 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 12F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 23F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 33F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 5 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 7F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 6B conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 19A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 19F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 8 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 15B conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 1 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 22F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 11A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 4 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 9V conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 10A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 18C conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate	Disease caused by Streptococcus pneumoniae		Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	10/11/2022
MHRA-100200-PIP01-21-M01 (update)	REGORAFENIB	Treatment of all malignant neoplasms (except haematopoietic and lymphoid tissue)	Stivarga Stivarga	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	04/11/2022
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

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