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Displaying 921 - 940 of 991

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PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Date Published Sort ascending
MHRA-100279-PIP01-21	Humanized monoclonal antibody of IgG1 sub-type targeting the human SEMA3A polypeptide	Diabetic retinopathy		Ophthamology	W: decision granting a waiver in all age groups for the listed condition(s).	No	04/05/2022
MHRA-100339-PIP01-21	Autologous selected renal cells	Treatment of Chronic Kidney Disease	Not available at present	Uro-Nephrology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	04/05/2022
MHRA-100390-PIP01-21-M01 (update)	Highly purified single-stranded, 5'-capped mRNA encoding full length SARS-CoV2 spike protein (BNT162b2)	Prevention of coronavirus disease 2019 (COVID-19)	Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) Comirnaty 30 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	27/04/2022
MHRA-100391-PIP01-21-M01 (update)	TOZINAMERAN	Prevention of coronavirus disease 2019 (COVID-19)	Comirnaty Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) Comirnaty 30 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	27/04/2022
MHRA-100392-PIP01-21-M01 (update)	TOZINAMERAN	Prevention of coronavirus disease 2019 (COVID-19)	Comirnaty Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) Comirnaty 30 micrograms/dose concentrate for dispersio n for injection COVID-19 mRNA Vaccine (nucleoside modified)	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	27/04/2022
MHRA-100164-PIP01-21	(1R,2S,5S)-N-((1S)-1-Cyano-2-((3S)-2-oxopyrrolidin-3-yl)ethyl)-3-((2S)-3,3-dimethyl-2-(2,2,2-trifluoroacetamido)butanoyl)-6,6-dimethyl-3-azabicyclo[3.1.0]hexane-2-carboxamide	Treatment of coronavirus disease 2019 (COVID-19) Prevention of coronavirus disease 2019 (COVID-19)	Not available at present	Infectious diseases	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	18/03/2022
MHRA-100168-PIP01-21-M01 (update)	Naloxegol (as naloxegol oxalate)	Treatment of opioid-induced constipation	Moventig Moventig Moventig Moventig Moventig Moventig Moventig Moventig Moventig Moventig Moventig Moventig	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	18/03/2022
MHRA-100163-PIP01-21	Vupanorsen (PF-07285557)	Treatment of Hypertriglyceridemia Prevention of cardiovascular events	Not available at present	Cardiovascular Diseases	W: decision granting a waiver in all age groups for the listed condition(s).	No	18/03/2022
MHRA-100156-PIP01-21-M01 (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 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® (fluocinolone acetonide intravitreal implant) 0.19 mg ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg ILUVIEN fluocinolone acetonide 190 micrograms intravitreal implant in applicator	Ophthamology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	18/03/2022
MHRA-100155-PIP01-21	efgartigimod alfa	Treatment of Chronic Inflammatory Demyelinating Polyneuropathy		Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No	18/03/2022
MHRA-100119-PIP01-21-M01 (update)	TEZACAFTOR IVACAFTOR	Treatment of Cystic Fibrosis	Symkevi Symkevi Symkevi	Pneumology - Allergology Other: Congenital, hereditary and neonatal diseases and abnormalities	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	18/03/2022
MHRA-100118-PIP01-21-M01 (update)	OCRELIZUMAB	Treatment of Multiple Sclerosis	Ocrevus Ocrevus Ocrevus	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	18/03/2022
MHRA-100107-PIP01-21	1-(3-methylbutanoyl)-l-aspartyl-l-threonyl-l-histidyl-l-phenylalanyl-l-prolyl-(l-cystinyl-l-isoleucyl-[(n6-(s)-4-carboxy-4-palmitamidobutanoyl)-l-lysinyl]-l-phenylalanyl-l-glutamyl-l-prolyl-l-arginyl-l-serinyl-l-lysinyl-l-glycinyl-l-cystinyl)-l-lysinamide, disulfide, acetate	Treatment of polycythaemia vera		Haematology-Hemostaseology	W: decision granting a waiver in all age groups for the listed condition(s).	No	18/03/2022
MHRA-100090-PIP01-21-M01 (update)	DUPILUMAB	Treatment of atopic dermatitis	Dupixent Dupixent	Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	18/03/2022
MHRA-100089-PIP01-21-M01 (update)	dupilumab	Treatment of eosinophilic oesophagitis	Dupixent Dupixent Dupixent	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	18/03/2022
MHRA-100084-PIP01-21-M01 (update)	MIDOSTAURIN	Treatment of acute myeloid leukaemia Malignant mastocytosis Mast cell leukaemia	Rydapt® 25 mg soft capsules Rydapt® 25 mg soft capsules Rydapt® 25 mg soft capsules Rydapt® 25 mg soft capsules	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	18/03/2022
MHRA-100112-PIP01-21	savolitinib	Treatment of renal neoplasms	Not available	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	18/03/2022
MHRA-100086-PIP01-21-M01 (update)	UPADACITINIB	Treatment of atopic dermatitis	Rinvoq	Immunology -Rheumatology-Transplantation Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	18/03/2022
MHRA-100093-PIP01-21-M01 (update)	UPADACITINIB	Treatment of chronic idiopathic arthritis	Rinvoq Rinvoq Rinvoq Rinvoq Rinvoq Rinvoq	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	18/03/2022
MHRA-100078-PIP01-21-M01 (update)	AZTREONAM AVIBACTAM	Treatment of infections caused by aerobic gram-negative bacteria	Not available at present	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	18/03/2022

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