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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-100330-PIP01-21	Autologous CD34+ hematopoietic stem and progenitor cells (HSPCs) genetically modified with the lentiviral vector IDUA LVV, encoding for the human α-L-iduronidase (IDUA) gene (OTL-203)	Treatment of Mucopolysaccharidosis type I, Hurler syndrome (MPS-IH)		Other: Metabolic disorders	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	29/07/2022
MHRA-100448-PIP01-22	RUXOLITINIB PHOSPHATE	Treatment of vitiligo	OPZELURA	Dermatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	29/07/2022
MHRA-100037-PIP01-21-M01 (update)	ponesimod	Treatment of Multiple Sclerosis	Ponvory	Neurology Other: Autoimmune disease/disfunction	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	29/07/2022
MHRA-100046-PIP01-21-M02 (update)	cenobamate	Treatment of epilepsy	Ontozry Ontozry Xcopri	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	29/07/2022
MHRA-100058-PIP01-21-M01 (update)	romosozumab	Treatment of osteoporosis	EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	29/07/2022
MHRA-100130-PIP01-21-M01 (update)	BUPIVACAINE	Postsurgical analgesia	EXPAREL liposomal EXPAREL EXPAREL EXPAREL EXPAREL EXPAREL EXPAREL	Pain	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	29/07/2022
MHRA-100143-PIP01-21-M01 (update)	TENOFOVIR ALAFENAMIDE FUMARATE	Treatment of chronic viral hepatitis B	Vemlidy	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	29/07/2022
MHRA-100117-PIP01-21-M01 (update)	ISATUXIMAB	Treatment of malignant neoplasms of the haematopoietic and lymphoid tissue	Sarclisa Sarclisa	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	29/07/2022
MHRA-100123-PIP01-21-M01 (update)	SARILUMAB	Treatment of chronic idiopathic arthritis	Kevzara Kevzara Kevzara Kevzara Kevzara	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	29/07/2022
MHRA-100145-PIP01-21-M01 (update)	BRIGATINIB	Non small cell lung cancer Anaplastic large cell lymphoma Inflammatory myofibroblastic tumours	Alunbrig Alunbrig Alunbrig Alunbrig Alunbrig Alunbrig Alunbrig Alunbrig Alunbrig Alunbrig Alunbrig Alunbrig Alunbrig Alunbrig	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	29/07/2022
MHRA-100170-PIP01-21-M01 (update)	CANAGLIFLOZIN HEMIHYDRATE	Treatment of Type 2 Diabetes Mellitus	Invokana	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	29/07/2022
MHRA-100166-PIP01-21-M01 (update)	ENTRECTINIB	Treatment of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms).	Rozlytrek Rozlytrek Rozlytrek Rozlytrek Rozlytrek Rozlytrek Rozlytrek Rozlytrek Rozlytrek Rozlytrek Rozlytrek Rozlytrek Rozlytrek Rozlytrek Rozlytrek	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	29/07/2022
MHRA-100183-PIP01-21-M01 (update)	AZILSARTAN MEDOXOMIL	Treatment of hypertension	Edarbi Edarbi	Cardiovascular Diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	29/07/2022
MHRA-100212-PIP01-21-M01 (update)	Finerenone	Treatment of Chronic Kidney Disease	Kerendia Kerendia	Uro-Nephrology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	29/07/2022
MHRA-100222-PIP01-21-M01 (update)	romosozumab	Treatment of osteoporosis	EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	29/07/2022
MHRA-100188-PIP01-21-M01 (update)	lebrikizumab	Treatment of atopic dermatitis		Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	29/07/2022
MHRA-100221-PIP01-21-M01 (update)	BARICITINIB	Treatment of atopic dermatitis	Olumiant Olumiant	Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	29/07/2022
MHRA-100250-PIP01-21-M01 (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	29/07/2022
MHRA-100252-PIP01-21-M01 (update)	GEMTUZUMAB OZOGAMICIN	Treatment of acute myeloid leukaemia	Mylotarg Mylotarg 16/06/2019 Mylotarg Mylotarg Mylotarg Mylotarg Mylotarg Mylotarg Mylotarg Mylotarg Mylotarg	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	29/07/2022
MHRA-100259-PIP01-21-M01 (update)	DULAGLUTIDE	Treatment of Type 2 Diabetes Mellitus	Trulicity Trulicity	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	29/07/2022

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