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Displaying 501 - 520 of 1097

PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Compliance outcome	Date Published Sort ascending
MHRA-100343-PIP01-21-M02 (update)	MACITENTAN	Treatment of pulmonary arterial hypertension Treatment of systemic sclerosis Treatment of idiopathic pulmonary fibrosis	Opsumit	Cardiovascular Diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-101023-PIP01-23-M02 (update)	ganaxolone	Treatment of cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder		Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	19/12/2023
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-100195-PIP01-21-M03 (update)	BALOXAVIR MARBOXIL	Treatment of Influenza Prevention of Influenza	Xofluza Xofluza Xofluza Xofluza Xofluza Xofluza Xofluza Xofluza Xofluza Xofluza Xofluza	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	19/12/2023
MHRA-100865-PIP01-23-M01 (update)	RILPIVIRINE	Treatment of human immunodeficiency virus (HIV-1) infection	REKAMBYS	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	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-100099-PIP01-21-M03 (update)	BRIVARACETAM	Treatment of paediatric epilepsy syndromes Treatment of neonatal seizures	Briviact (in Italy: Nubriveo) Briviact Briviact Briviact Briviact	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	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-100098-PIP01-21-M02 (update)	ATALUREN	Treatment of dystrophinopathy	Translarna	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	19/12/2023
MHRA-100465-PIP01-22-M02 (update)	efanesoctocog alfa	Treatment of congenital haemophilia A		Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		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

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