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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-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-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-101230-PIP01-23	teprotumumab	Treatment of thyroid eye disease	Not available at present TEPEZZA	Ophthamology	W: decision granting a waiver in all age groups for the listed condition(s).	No		30/04/2024
MHRA-101122-PIP01-23	ENFORTUMAB VEDOTIN	Treatment of head and neck epithelial malignant neoplasms	Padcev Padcev Padcev	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		30/04/2024
MHRA-101100-PIP01-23	Derivative of a benzoimidazole substituted pyrimidine (PF-07220060)	Treatment of breast malignant neoplasms		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		30/04/2024
MHRA-101085-PIP01-23	Humanised IgG1 monoclonal antibody against integrin beta-6 conjugated to monomethyl auristatin E via a valine-citrulline linker	Treatment of non-small cell lung cancer		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		30/04/2024
MHRA-101355-PIP01-24	(3S,10S,14S)-1-[4-[[(2S)-4-carboxy-2-[(2S)-4-carboxy-2-(6-[18F] fluoropyridin-3-amido)butanamido]butanamido]methyl]phenyl]-3-[(naphthalen-2-yl)methyl]-1,4,12-trioxo-2,5,11,13-tetraazahexadecane-10,14,16-tricarboxylic acid ([18F]PSMA-1007)	Visualisation of prostate specific membrane antigen in prostate cancer	Radelumin	Diagnostic Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		30/04/2024
MHRA-100986-PIP02-23	ENCORAFENIB	Treatment of lung cancer	Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		30/04/2024

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