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PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check Sort descending	Date Published
MHRA-100097-PIP01-21-M01 (update)	eladocagene exuparvovec	Treatment of Aromatic L-Amino Acid Decarboxylase (AADC) Deficiency	Upstaza	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	17/12/2021
MHRA-100098-PIP01-21-M01 (update)	ATALUREN	Treatment of dystrophinopathy	Translarna Translarna Translarna Translarna Translarna Translarna Translarna Translarna	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	17/12/2021
MHRA-100131-PIP01-21	ATEZOLIZUMAB	Treatment of all malignant neoplasms (except CNS tumours, haematopoietic, lymphoid neoplasms)	Tecentriq Tecentriq Tecentriq Tecentriq	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	17/12/2021
MHRA-100128-PIP01-21-M01 (update)	bis-choline tetrathiomolybdate	Treatment of Wilson disease		Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	17/12/2021
MHRA-100148-PIP01-21-M01 (update)	LENVATINIB MESILATE	Treatment of all conditions included in the category of malignant neoplasms	Lenvima Kisplyx Lenvima Kisplyx Lenvima Kisplyx	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	17/12/2021
MHRA-100142-PIP01-21	Synthetic Hypericin	Treatment of cutaneous T-cell lymphoma	HyBryte	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	17/12/2021
MHRA-100154-PIP01-21-M01 (update)	Cotadutide	Treatment of Type 2 Diabetes Mellitus	Not available at present	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	17/12/2021
MHRA-100160-PIP01-21-M01 (update)	TOCILIZUMAB	Cytokine release syndrome due to (CAR) T cell therapy or T-cell- bispecific antibody therapy	RoActemra RoActemra	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	17/12/2021
MHRA-100080-PIP01-21	Anti-C1s Humanized IgG4 Monoclonal Antibody	Treatment of Immune Thrombocytopenic Purpura		Neurology Immunology -Rheumatology-Transplantation Haematology-Hemostaseology	W: decision granting a waiver in all age groups for the listed condition(s).	No	17/12/2021
MHRA-100079-PIP01-21-M01 (update)	gilteritinib (as fumarate)	Treatment of acute myeloid leukaemia	Xospata Xospata	Haematology-Hemostaseology Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	17/03/2022
MHRA-100076-PIP01-21-M01 (update)	TENOFOVIR DISOPROXIL FUMARATE	Treatment of human immunodeficiency virus (HIV-1) infection Treatment of chronic viral hepatitis B	Viread	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	18/03/2022
MHRA-100072-PIP01-21-M01 (update)	COVID-19 Vaccine (ChAdOx1-S [recombinant])	Prevention of coronavirus disease 2019 (COVID-19)	COVID-19 Vaccine AstraZeneca COVID-19 Vaccine AstraZeneca	Vaccines	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
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-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-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-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-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-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-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

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