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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-100574-PIP01-22	lixmabegagene relduparvovec	Treatment of GM1 gangliosidosis		Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	02/02/2023
MHRA-100556-PIP01-22	Anti-C1s Humanized IgG4 Monoclonal Antibody	Treatment of chronic inflammatory demyelinating polyradiculoneuropathy		Neurology Immunology -Rheumatology-Transplantation Haematology-Hemostaseology	W: decision granting a waiver in all age groups for the listed condition(s).	No	07/12/2022
MHRA-100458-PIP01-22	Modakafusp alfa	Treatment of multiple myeloma		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	07/12/2022
MHRA-100135-PIP02-22	anti-CD40L humanised monoclonal antibody (SAR441344)	Treatment of progressive Multiple Sclerosis		Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No	07/12/2022
MHRA-100476-PIP01-22	Anti-(alpha-synuclein) human monoclonal antibody	Treatment of Multiple System Atrophy Treatment of Parkinson's Disease		Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No	07/12/2022
MHRA-100481-PIP01-22	TUCATINIB	Treatment of solid tumours	Tukysa	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	07/12/2022
MHRA-100404-PIP01-21	insulin icodec SEMAGLUTIDE	Treatment of type 2 diabetes mellitus		Endocrinology-Gynaecology-Fertility-metabolism	W: decision granting a waiver in all age groups for the listed condition(s).	No	07/12/2022
MHRA-100365-PIP01-21	Batiraxcept	Treatment of Ovarian cancer Treatment of Fallopian tube cancer Treatment of Primary peritoneal cancer		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	07/12/2022
MHRA-100395-PIP01-21	TALAZOPARIB TOSYLATE	Treatment of breast malignant neoplasms Treatment of prostate malignant neoplasms	Talzenna Talzenna Talzenna Talzenna Talzenna Talzenna	Psychiatry Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	07/12/2022
MHRA-100366-PIP01-21	Cevostamab	Treatment of multiple myeloma		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	07/12/2022
MHRA-100383-PIP01-21	TRASTUZUMAB DERUXTECAN	Treatment of lung cancer	Enhertu Enhertu Enhertu	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	07/12/2022
MHRA-100401-PIP01-21	Humanised IgG2k Fc-modified bispecific antibody against CD3 and BCMA (PF-06863135)	Treatment of multiple myeloma		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	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-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

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