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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-100593-PIP01-22	aticaprant	Treatment of Major Depressive Disorder	Not available at present	Psychiatry	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	30/01/2024
MHRA-101016-PIP01-23	ublituximab	Treatment of multiple sclerosis	Briumvi Briumvi	Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	20/12/2023
MHRA-101079-PIP01-23-M01 (update)	ZANUBRUTINIB	Treatment of lymphoplasmacytic lymphoma Treatment of mature B-cell neoplasms (excluding lymphoplasmacytic lymphoma)	Brukinsa Brukinsa Brukinsa Brukinsa Brukinsa Brukinsa Brukinsa Brukinsa	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/12/2023
MHRA-100878-PIP01-23	vibegron	Treatment of myoneurogenic bladder disorders		Uro-Nephrology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	19/12/2023
MHRA-100995-PIP01-23	LysoPhosphatidic Acid receptor 1 (LPA1) antagonist (BMS-986278)	Treatment of fibrosing Interstitial Lung Diseases (ILD)		Pneumology - Allergology	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/12/2023
MHRA-100301-PIP04-23	Nipocalimab	Treatment of chronic inflammatory demyelinating polyradiculoneuropathy		Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/12/2023
MHRA-100301-PIP03-23	Nipocalimab	Treatment of Sjögren’s syndrome		Immunology -Rheumatology-Transplantation	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/12/2023
MHRA-100974-PIP01-23	BOTULINUM TOXIN TYPE A	Treatment of skin wrinkling	Not yet defined	Other: Aesthetics	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/12/2023
MHRA-100834-PIP01-23	SOTORASIB	Treatment of colorectal carcinoma	Lumykras Lumykras	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/12/2023
MHRA-100829-PIP01-22	Edaravone	Treatment of Amyotrophic lateral sclerosis	Not available at this moment	Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/12/2023
MHRA-100917-PIP01-23	efgartigimod alfa	Treatment of Bullous Pemphigoid	Vyvgart Vyvgart Vyvgart Vyvgart	Dermatology	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/12/2023
MHRA-100927-PIP01-23	Namilumab	Treatment of sarcoidosis	Not available at present	Immunology -Rheumatology-Transplantation	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/12/2023
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
MHRA-100874-PIP01-23	PEMBROLIZUMAB	Treatment of all conditions included in the category of malignant neoplasms (except nervous system, haematopoietic and lymphoid tissue) Treatment of Hodgkin lymphoma	Keytruda	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/12/2023
MHRA-100848-PIP01-23	messenger RNA encoding Cas9, single guide RNA targeting the human TTR gene	Treatment for transthyretin amyloidosis (ATTR)	Not available at present	Neurology Cardiovascular Diseases	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/12/2023
MHRA-100873-PIP01-23	Meningococcal Group A, C, W-135 and Y conjugate vaccine	Meningococcal meningitis	Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo	Vaccines	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/12/2023
MHRA-101019-PIP01-23	Treprostinil Palmitil	Treatment of pulmonary hypertension due to lung disease and/or hypoxia.	Not available at present	Pneumology - Allergology	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/12/2023
MHRA-100882-PIP01-23	Glucagon analogue linked to a human immunoglobulin Fc fragment	Treatment of congenital hyperinsulinism		Endocrinology-Gynaecology-Fertility-metabolism	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	19/12/2023
MHRA-100957-PIP01-23	deucravacitinib	Treatment of chronic idiopathic arthritis (including rheumatoid arthritis,psoriatic arthritis, ankylosing spondylitis & juvenile idiopathic arthritis)	SOTYKTU SOTYKTU SOTYKTU SOTYKTU SOTYKTU SOTYKTU SOTYKTU	Immunology -Rheumatology-Transplantation	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	19/12/2023
MHRA-100722-PIP01-22	Ritlecitinib	Treatment of vitiligo		Dermatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	19/12/2023

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