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PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Date Published Sort ascending
MHRA-101730-PIP01-24	Ifinatamab deruxtecan	Treatment of oesophageal cancer		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	02/05/2025
MHRA-100297-PIP01-21-M04 (update)	Human, recombinant, non-fucosylated IgG1k monoclonal antibody targeting OX-40 receptor on activated T cells (rocatinlimab)	Treatment of atopic dermatitis		Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/05/2025
MHRA-101660-PIP01-24	RUXOLITINIB PHOSPHATE	Treatment of prurigo nodularis	OPZELURA OPZELURA OPZELURA OPZELURA	Dermatology	W: decision granting a waiver in all age groups for the listed condition(s).	No	02/05/2025
MHRA-101412-PIP01-24	Pridopidine hydrochloride	Treatment of amyotrophic lateral sclerosis (ALS)	Nurzigma	Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No	02/05/2025
MHRA-101413-PIP01-24	BLINATUMOMAB	Treatment of acute lymphoblastic leukaemia	BLINCYTO	Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	02/05/2025
MHRA-101770-PIP01-24	SEMAGLUTIDE	Treatment of Chronic Kidney Disease	Ozempic Ozempic Ozempic Ozempic Ozempic	Uro-Nephrology	W: decision granting a waiver in all age groups for the listed condition(s).	No	02/05/2025
MHRA-100910-PIP01-23-M03 (update)	ABEMACICLIB	Treatment of glioma	Verzenios Verzenios	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/05/2025
MHRA-100156-PIP01-21-M02 (update)	FLUOCINOLONE ACETONIDE	Treatment of non-infectious uveitis Secondary prevention of non-infectious uveitis	ILUVIEN 190 micrograms intravitreal implant in applicator ILUVIEN 190 micrograms intravitreal implant in applicator ILUVIEN 190 Mikrogramm intravitreales Implantat im Applikator ILUVIEN 190 microgrammes, implant intravitréen avec applicateur ILUVIEN 190 mikrogramů intravitreální implantát v aplikátoru ILUVIEN Iluvien 190 mikrogrammaa, implantaatti silmän lasiaiseen, asetin ILUVIEN 190 microgrammes, implant intravitréen avec applicateur ILUVIEN 190 Mikrogramm intravitreales Implantat im Applikator ILUVIEN 190 microgrammi impianto intravitreale in applicatore ILUVIEN 190 microgrammes, implant intravitréen avec applicateur ILUVIEN 190 microgram, intravitreaal implant in applicator Iluvien 190 mikrogram intravitrealt implantat i applikator ILUVIEN, 190 mikrogramów, implant do ciałka szklistego w aplikatorze ILUVIEN 190 microgramas implante intravítreo em aplicador ILUVIEN 190 microgramos implante intravítreo en aplicador Iluvien 190 mikrogram intravitrealt implantat i applikator ILUVIEN 190 micrograms intravitreal implant in applicator	Ophthamology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/05/2025
MHRA-100093-PIP01-21-M05 (update)	UPADACITINIB	Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, spondyloarthritis and juvenile idiopathic arthritis).	Rinvoq Rinvoq Rinvoq Rinvoq Rinvoq Rinvoq Rinvoq Rinvoq Rinvoq Rinvoq Rinvoq Rinvoq Rinvoq Rinvoq Rinvoq	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/05/2025
MHRA-100579-PIP01-22-M04 (update)	Maribavir	Treatment of cytomegalovirus (CMV)	Livtencity Livtencity Livtencity Livtencity	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/05/2025
MHRA-101671-PIP01-24	PEGCETACOPLAN	Treatment of glomerulonephritis and nephrotic syndrome	ASPAVELI ASPAVELI	Uro-Nephrology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	02/05/2025
MHRA-100325-PIP01-21-M02 (update)	NALDEMEDINE	Treatment of opioid induced constipation	Rizmoic Rizmoic SYMPROIC SYMPROIC SYMPROIC Symproic Symproic	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/05/2025
MHRA-100209-PIP01-21-M02 (update)	survodutide	Treatment of obesity	Not available at present	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/05/2025
MHRA-101739-PIP01-24-M01 (update)	ASCORBIC ACID MACROGOL 3350 POTASSIUM CHLORIDE SODIUM ASCORBATE SODIUM CHLORIDE SODIUM SULPHATE	Bowel cleansing prior to clinical procedures	PLENVU PLENVU® powder for oral solution PLEINVUE™ Pulver zur Herstellung einer Lösung zum Einnehmen PLENVU® powder for oral solution PLENVU® powder for oral solution Plenvu prašak za oralnu otopinu PLENVU PLENVU® powder for oral solution PLENVU® powder for oral solution PLENVU, poudre pour solution buvable PLENVU® powder for oral solution PLENVU por belsőleges oldathoz PLENVU® powder for oral solution PLENVU® powder for oral solution PLENVU® powder for oral solution PLENVU Pleinvue™ powder for oral solution PLENVU PLENVU® powder for oral solution PLENVU PLENVU® powder for oral solution Plenvu pulbere pentru soluție orală PLENVU Plenvu prašek za peroralno raztopino PLENVU Powder Pleinvue polvo para solución oral PLENVU Plenvu, Pulver PLENVU PLENVU® powder for oral solution PLENVU PLENVU Powder for oral solution PLENVU Powder for oral solution PLENVU, POLVO PARA SOLUCIÓN ORAL PLENVU, POLVO PARA SOLUCIÓN ORAL PLENVU, POLVO PARA SOLUCIÓN ORAL PLENVU POLVO PARA SOLUCIÓN ORAL PLENVU, POLVO PARA SOLUCIÓN ORAL PLENVU, POLVO PARA SOLUCIÓN ORAL PLENVU, powder for oral solution PLENVU	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/05/2025
MHRA-101185-PIP01-23	gefurulimab	Treatment of myasthenia gravis		Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	02/05/2025
MHRA-101417-PIP01-24	Plozasiran (USAN)(synthetic double-stranded siRNA oligonucleotide directed against apolipoprotein C-III mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues)	Familial chylomicronaemia syndrome (FCS)	Redemplo	Cardiovascular Diseases	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	02/05/2025
MHRA-100734-PIP01-22	tideglusib	Treatment of myotonic dystrophy		Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	02/05/2025
MHRA-100851-PIP01-23 -M01 (update)	NEISSERIA MENINGITIDIS GROUP C POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN NEISSERIA MENINGITIDIS GROUP A POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN NEISSERIA MENINGITIDIS GROUP W-135 POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN NEISSERIA MENINGITIDIS GROUP Y POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN Recombinant Neisseria meningitidis serogroup B protein 1 Recombinant Neisseria meningitidis serogroup B protein 2 Recombinant Neisseria meningitidis serogroup B Protein-based active substance Recombinant Neisseria meningitidis serogroup B protein 3	Prevention of meningococcal disease (serogroups A, B, C, W and Y)		Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	09/04/2025
MHRA-100129-PIP01-21-M02 (update)	Cipaglucosidase alfa	Treatment of glycogen storage disease Type II (Pompe's disease)	Pombiliti Pombilti Pombiliti	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	08/04/2025
MHRA-101694-PIP01-24	Human IgG1 monoclonal antibody targeting amyloid transthyretin	Treatment of transthyretin-mediated amyloidosis		Neurology Cardiovascular Diseases	W: decision granting a waiver in all age groups for the listed condition(s).	No	08/04/2025

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