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PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area Sort descending	Decision Type	Compliance Check	Date Published
MHRA-101030-PIP01-23	Inhibitor of receptor-interacting serine/threonine-protein kinase 1 (RIPK1) (SAR443820)	Treatment of Amyotrophic lateral sclerosis		Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No	30/01/2024
MHRA-101287-PIP01-23	SUMATRIPTAN NAPROXEN SODIUM	Treatment of migraine headaches	Suvexx 85 mg/500 mg film-coated tablets FI, DK, HU, NO, SE: Nomigrin EE, LT, LV: Migsun PL: Frimig Duo	Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No	30/04/2024
MHRA-101115-PIP01-23	Sodium ({(2S)-1,4-bis[2-(4-chloro-3-fluorophenoxy)acetamido]bicyclo[2.2.2]octan-2-yl}oxy)methyl hydrogen phosphate-2-amino-2-(hydroxymethyl)propane-1,3-diol (1/1/1)	Treatment of Amyotrophic lateral sclerosis	Not available at present	Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No	30/04/2024
MHRA-100190-PIP01-21	Ordesekimab	Treatment of coeliac disease		Gastroenterology-Hepatology Immunology -Rheumatology-Transplantation	W: decision granting a waiver in all age groups for the listed condition(s).	No	29/07/2022
MHRA-100163-PIP01-21	Vupanorsen (PF-07285557)	Treatment of Hypertriglyceridemia Prevention of cardiovascular events	Not available at present	Cardiovascular Diseases	W: decision granting a waiver in all age groups for the listed condition(s).	No	18/03/2022
MHRA-100122-PIP01-21	olpasiran	Prevention of cardiovascular events		Cardiovascular Diseases	W: decision granting a waiver in all age groups for the listed condition(s).	No	29/07/2022
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-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-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-100572-PIP01-22	autologous bone marrow-derived mononuclear cell enriched white blood cells	Treatment of chronic limb-threatening ischemia		Cardiovascular Diseases	W: decision granting a waiver in all age groups for the listed condition(s).	No	02/02/2023
MHRA-100577-PIP01-22	ziltivekimab	Treatment of heart failure	Not available at present	Cardiovascular Diseases	W: decision granting a waiver in all age groups for the listed condition(s).	No	25/05/2023
MHRA-100684-PIP01-22	Clazakizumab	Prevention of cardiovascular events in patients with atherosclerosis	Not available at present	Cardiovascular Diseases	W: decision granting a waiver in all age groups for the listed condition(s).	No	30/06/2023
MHRA-100206-PIP01-21	EMPAGLIFLOZIN	Treatment of ischaemic heart disease	Jardiance Jardiance	Endocrinology-Gynaecology-Fertility-metabolism	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/05/2022
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-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-101270-PIP01-23	SEMAGLUTIDE	Prevention of cardiovascular events in patients with atherosclerosis	Wegovy Wegovy Wegovy Wegovy Wegovy Wegovy Wegovy Wegovy Wegovy Wegovy Wegovy Wegovy Wegovy Wegovy Wegovy Wegovy Wegovy Wegovy Wegovy Wegovy Wegovy Wegovy Wegovy Wegovy	Endocrinology-Gynaecology-Fertility-metabolism	W: decision granting a waiver in all age groups for the listed condition(s).	No	30/04/2024
MHRA-100135-PIP01-21	anti-CD40L humanized monoclonal antibody (SAR441344)	Treatment of Sjogren's Syndrome		Immunology -Rheumatology-Transplantation	W: decision granting a waiver in all age groups for the listed condition(s).	No	17/05/2022
MHRA-100295-PIP01-21	Adalimumab conjugated with (4S)-4-[2-(2-bromoacetamido)acetamido]-5-{3-[(4-{(4aR,4bS,5S,6aS,6bS,8R,9aR,10aS,10bS)-5-hydroxy-4a,6a-dimethyl-2-oxo-6b-[(phosphonooxy)acetyl]-4a,4b,5,6,6a,6b,9a,10,10a,10b,11,12-dodecahydro-2H,8H-naphtho[2',1':4,5]indeno[1,2-d][1,3]dioxol-8-yl}phenyl)methyl] anilino}-5-oxopentanoic acid; (ABBV-154).	Treatment of polymyalgia rheumatica		Immunology -Rheumatology-Transplantation	W: decision granting a waiver in all age groups for the listed condition(s).	No	27/09/2022
MHRA-100587-PIP01-22	lusvertikimab	Treatment of Sjögren’s syndrome		Immunology -Rheumatology-Transplantation	W: decision granting a waiver in all age groups for the listed condition(s).	No	25/05/2023
MHRA-100850-PIP01-23	deucravacitinib	Treatment of Sjogren's Syndrome	SOTYKTU SOTYKTU SOTYKTU SOTYKTU SOTYKTU	Immunology -Rheumatology-Transplantation	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/12/2023

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