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PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Compliance outcome	Date Published Sort ascending
MHRA-100164-PIP01-21-M02 (update)	Nirmatrelvir RITONAVIR	Treatment of coronavirus disease 2019 (COVID-19) Prevention of Coronavirus Disease 2019 (COVID-19)	Paxlovid Paxlovid Paxlovid Paxlovid Paxlovid Paxlovid	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/06/2023
MHRA-100717-PIP01-22-M01 (update)	RISDIPLAM	Treatment of spinal muscular atrophy	Evrysdi Evrysdi Evrysdi Evrysdi Evrysdi Evrysdi Evrysdi Evrysdi	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/06/2023
MHRA-100130-PIP01-21-M02 (update)	BUPIVACAINE	Postsurgical analgesia	EXPAREL liposomal EXPAREL EXPAREL EXPAREL EXPAREL	Pain	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/06/2023
MHRA-100351-PIP01-21-M01 (update)	DOLUTEGRAVIR RILPIVIRINE	Treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection.	JULUCA JULUCA JULUCA JULUCA JASUPA Juluca 50mg/25mg film-coated tablets JULUCA 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		30/06/2023
MHRA-100959-PIP01-23-M01 (update)	DOSTARLIMAB	Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid malignancies).	Jemperli Jemperli Jemperli	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	30/06/2023
MHRA-100475-PIP01-22-M01 (update)	Neisseria meningitidis serogroup A polysaccharide conjugated to tetanus toxoid Neisseria meningitidis serogroup C polysaccharide conjugated to tetanus toxoid Neisseria meningitidis serogroup Y polysaccharide conjugated to tetanus toxoid Neisseria meningitidis serogroup W polysaccharide conjugated to tetanus toxoid	Prevention of invasive meningococcal disease	MenQuadfi MenQuadfi	Vaccines	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-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-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-100349-PIP01-21-M02 (update)	Rezafungin acetate	Treatment of invasive candidiasis	Rezzayo 200 mg powder for concentrate for solution for infusion	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/06/2023
MHRA-100323-PIP01-21-M02 (update)	SAXAGLIPTIN	Treatment of Type 2 Diabetes Mellitus	Onglyza Onglyza Onglyza Onglyza Onglyza	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-100709-PIP01-22-M02 (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-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-100250-PIP01-21-M02 (update)	VERICIGUAT	Treatment of left ventricular failure	Verquvo Verquvo Verquvo Verquvo	Cardiovascular Diseases	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-100614-PIP01-22-M01 (update)	VONICOG ALFA	Treatment of von Willebrand Disease	veyvondi veyvondi Vonvendi veyvondi Vonvendi veyvondi Vonvendi veyvondi	Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/06/2023
MHRA-100535-PIP01-22-M02 (update)	FLUTICASONE FUROATE UMECLIDINIUM BROMIDE VILANTEROL TRIFENATATE	Treatment of asthma	Trelegy Ellipta Trelegy Ellipta Trelegy Ellipta/ Elebrato Ellipta Trelegy Ellipta	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/06/2023

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