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PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Compliance outcome	Date Published Sort ascending
MHRA-100046-PIP01-21-M04 (update)	cenobamate	Treatment of epilepsy	Ontozry Ontozry Xcopri Ontozry	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024
MHRA-100564-PIP01-22-M02 (update)	TEDIZOLID PHOSPHATE	Treatment of acute bacterial skin and skin structure infections	Sivextro Sivextro Sivextro	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024
MHRA-100479-PIP01-22-M02 (update)	POSACONAZOLE	Prevention of invasive fungal infections Treatment of invasive fungal infections	Noxafil Noxafil Noxafil Noxafil Noxafil Noxafil Noxafil Noxafil Noxafil Noxafil	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024
MHRA-100468-PIP01-22-M02 (update)	EPTINEZUMAB	Prevention of migraine headaches	Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024
MHRA-100462-PIP01-22-M02 (update)	FENFLURAMINE HYDROCHLORIDE	Treatment of Dravet Syndrome	Fintepla Fintepla Fintepla Fintepla Fintepla	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024
MHRA-100442-PIP01-22-M02 (update)	TALIMOGENE LAHERPAREPVEC	Treatment of melanoma	Imlygic Imlygic Imlygic	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	30/04/2024
MHRA-100351-PIP01-21-M02 (update)	DOLUTEGRAVIR RILPIVIRINE	Treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection.	Juluca 50mg/25mg film-coated tablets JULUCA JULUCA JULUCA JULUCA JULUCA JASUPA JULUCA JULUCA JULUCA JULUCA JULUCA JULUCA JULUCA JULUCA JULUCA JULUCA JULUCA JULUCA	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024
MHRA-100068-PIP01-21-M02 (update)	VEDOLIZUMAB	Treatment of Pouchitis	Entyvio Entyvio		PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024
MHRA-101044-PIP01-23-M01 (update)	INCLISIRAN SODIUM	Treatment of elevated cholesterol	Leqvio Leqvio Leqvio Leqvio	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024
MHRA-101008-PIP01-23-M01 (update)	AMBRISENTAN	Pulmonary Arterial Hypertension	Volibris Volibris	Cardiovascular Diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024
MHRA-100300-PIP01-21-M03 (update)	DARUNAVIR COBICISTAT	Treatment of human immunodeficiency virus (HIV-1) infection		Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024
MHRA-100301-PIP05-23	Nipocalimab	Treatment of Idiopathic inflammatory myopathies		Immunology -Rheumatology-Transplantation	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		30/04/2024
MHRA-101118-PIP01-23	5’-capped mRNA encoding HPV16 oncoprotein E6 5’-capped mRNA encoding HPV16 oncoprotein E7	Treatment of head and neck squamous cell carcinoma	Not available at present	Oncology	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-100913-PIP01-23	mRNA that encodes for the NTD and RBD epitopes of the spike glycoprotein of SARS-CoV-2 (mRNA-1283)	Prevention of coronavirus disease 2019 (COVID-19)	Not available at present	Infectious diseases Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		30/04/2024
MHRA-100797-PIP01-22	Single-stranded 5' capped mRNA encoding the HAs of the influenza virus strains A and B (mRNA-1010)	Prevention of influenza disease	Not available at present	Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		30/04/2024
MHRA-100789-PIP01-22	Fazirsiran	Treatment of congenital alpha-1 antitrypsin deficiency	Not available at present	Gastroenterology-Hepatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		30/04/2024
MHRA-100698-PIP01-22	Nemvaleukin Alfa	Treatment of all conditions included in the category of malignant neoplasms (except CNS, haematopoietic and lymphoid tissue) Treatment of malignant neoplasms of the lymphoid tissue		Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		30/04/2024
MHRA-100562-PIP01-22	strontium-82 chloride/ rubidium-82 chloride	Visualisation of myocardial perfusion for diagnostic purposes	Ruby-Fill Ruby-Fill Ruby-Fill	Cardiovascular Diseases Diagnostic	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024
MHRA-100558-PIP01-22	milvexian	Prevention of thromboembolism in patients with cardiovascular disease	Not available at present	Cardiovascular Diseases	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		30/04/2024

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