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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-101023-PIP01-23-M01 (update)	ganaxolone	Treatment of cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder	ZTALMY ZTALMY	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100868-PIP01-23-M01 (update)	AFAMELANOTIDE	Treatment of erythropoietic protoporphyria (EPP)	SCENESSE SCENESSE SCENESSE SCENESSE SCENESSE SCENESSE	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100601-PIP01-22-M02 (update)	elasomeran imelasomeran DAVESOMERAN	Prevention of coronavirus disease 2019 (COVID-19)	Spikevax Spikevax Spikevax bivalent Original/Omicron BA.1 Spikevax Spikevax bivalent Original/Omicron BA.1 Spikevax bivalent Original/Omicron BA.4-5 Spikevax bivalent Original/Omicron BA.1 Spikevax bivalent Original/Omicron BA.1 Spikevax bivalent Original/Omicron BA.4-5 Spikevax bivalent Original/Omicron BA.4-5	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100137-PIP01-21-M02 (update)	linaclotide	Treatment of functional constipation	Constella Constella Constella Constella Constella	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100779-PIP01-22-M01 (update)	GUSELKUMAB	Treatment of chronic idiopathic arthritis (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and juvenile idiopathic arthritis)	TREMFYA TREMFYA TREMFYA TREMFYA TREMFYA	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100289-PIP01-21-M03 (update)	GALCANEZUMAB	Prevention of migraine headache	Emgality Emgality Emgality Emgality Emgality Emgality	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	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

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