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PIPS Search Results
PIP Number	Active Substance Sort ascending	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Compliance outcome	Date Published
MHRA-100714-PIP01-22-M01 (update)	Gepotidacin	Treatment of uncomplicated urogenital gonorrhoea (GC)		Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/06/2023
MHRA-100720-PIP01-22-M01 (update)	Gepotidacin	Treatment of uncomplicated urinary tract infections		Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/06/2023
MHRA-100720-PIP01-22-M02 (update)	Gepotidacin	Treatment of uncomplicated urinary tract infection	Not available at present	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	24/08/2023
MHRA-100709-PIP01-22-M01 (update)	rozanolixizumab	Treatment of myasthenia gravis		Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/06/2023
MHRA-100447-PIP01-22-M02 (update)	Tirzepatide	Treatment of Type 2 Diabetes Mellitus	Mounjaro Mounjaro	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/06/2023
MHRA-100799-PIP01-22-M01 (update)	BEDAQUILINE FUMARATE	Treatment of multi-drug resistant tuberculosis	Sirturo	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/06/2023
MHRA-100553-PIP01-22-M01 (update)	REMIMAZOLAM BESYLATE	Sedation General Anaesthesia	Byfavo 20mg Anerem Byfavo Byfavo Byfavo	Anaesthesiology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	30/06/2023
MHRA-100701-PIP01-22-M01 (update)	Outer Membrane Vesicles (OMV) from N. meningitidis Strain NZ 98/254 Recombinant Neisseria meningitis group B Protein 936-741 Meningococcal group W-135 oligosaccharides conjugated to Corynebacterium diphtheriae CRM197 protein Meningococcal group A oligosaccharides conjugated to Corynebacterium diphtheriae CRM197 protein Meningococcal group C oligosaccharides conjugated to Corynebacterium diphtheriae CRM197 protein Recombinant Neisseria meningitis group B Protein 287- 953 Recombinant Neisseria meningitis group B Protein 961c Meningococcal group Y oligosaccharides conjugated to Corynebacterium diphtheriae CRM197 protein	Prevention of meningococcal meningitis		Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/06/2023
MHRA-100645-PIP01-22-M01 (update)	AMIKACIN SULFATE	Treatment of Pseudomonas aeruginosa lung infection/colonisation in cystic fibrosis patients Treatment of non-tuberculous mycobacterial lung infection	Arikayce Arikayce Arikayce liposomal	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/06/2023
MHRA-100805-PIP01-22-M01 (update)	ATIDARSAGENE AUTOTEMCEL	Treatment of metachromatic leukodystrophy (MLD)	Libmeldy Libmeldy Libmeldy	Other: Lysosomal storage Disorder	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/06/2023
MHRA-100544-PIP01-22-M01 (update)	sebetralstat	Treatment of hereditary angioedema		Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/06/2023
MHRA-100544-PIP01-22-M02 (update)	sebetralstat	Treatment of hereditary angioedema		Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/01/2024
MHRA-100515-PIP01-22-M01 (update)	VORTIOXETINE	Treatment of Major Depressive Disorder	Brintellix Brintellix Brintellix	Psychiatry	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		30/06/2023
MHRA-100687-PIP01-22-M01 (update)	OBINUTUZUMAB	Treatment of systemic lupus erythematosus	Gazyvaro Gazyvaro	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		24/08/2023
MHRA-100681-PIP01-22	Lomitapide	Treatment of (heterozygous or homozygous) familial hypercholesterolaemia	Lojuxta hard capsule	Other: Hypercholesterolaemia (HoFH)	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/06/2023
MHRA-100845-PIP01-23-M01 (update)	CABOTEGRAVIR	Prevention of human immunodeficiency virus (HIV-1) infection	VOCABRIA and CABENUVA Apretude APRETUDE Apretude VOCABRIA/APRETUDE	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		20/06/2023
MHRA-100845-PIP01-23-M02 (update)	CABOTEGRAVIR	Prevention of human immunodeficiency virus (HIV-1) infection	N/A VOCABRIA AND APRETUDE Apretude N/A N/A N/A Apretude Apretude	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	20/06/2023
MHRA-100901-PIP01-23-M01 (update)	CABOTEGRAVIR	Treatment of human immunodeficiency virus (HIV-1) infection	Vocabria	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100901-PIP01-23-M02 (update)	CABOTEGRAVIR	Treatment of human immunodeficiency virus (HIV-1) infection	Vocabria Vocabria / Cabenuva Vocabria Vocabria Vocabria Vocabria Vocabria Vocabria Vocabria Vocabria / Cabenuva Vocabria / Cabenuva Vocabria	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	19/12/2023
MHRA-100567-PIP01-22-M01 (update)	Dinutuximab beta	Treatment of neuroblastoma	Qarziba Qarziba	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023

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