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Displaying 181 - 199 of 199

PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Compliance outcome	Date Published Sort ascending
MHRA-100844-PIP01-23-M01 (update)	IVACAFTOR	Treatment of cystic fibrosis.	Kalydeco Kalydeco Kalydeco Kalydeco Kalydeco Kalydeco Kalydeco	Other: Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	24/08/2023
MHRA-100177-PIP01-21-M02 (update)	INFLUENZA A/ (H1N1)-LIKE VIRUS ANTIGEN INFLUENZA A/ (H3N2)-LIKE VIRUS ANTIGEN INFLUENZA B/VICTORIA/2/87-LIKE VIRUS ANTIGEN INFLUENZA B/YAMAGATA/16/88-LIKE VIRUS ANTIGEN	Prevention of Influenza	FLUCELVAX TETRA Cell-based Quadrivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe FLUCELVAX TETRA	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	24/08/2023
MHRA-100775-PIP01-22-M02 (update)	(4R,5R)-1-[[4-[[4-[3,3-Dibutyl-7-(dimethylamino)-2,3,4,5-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl] phenoxy] methyl] phenyl] methyl]-4-aza-1-azoniabicyclo[2.2.2]octane Chloride Maralixibat chloride	Treatment of Alagille Syndrome (ALGS)	Livmarli (maralixibat chloride) LIVMARLI	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	01/08/2023
MHRA-100846-PIP01-23-M01 (update)	ENALAPRIL MALEATE	Treatment of heart failure		Cardiovascular Diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		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-100515-PIP01-22-M01 (update)	VORTIOXETINE	Treatment of Major Depressive Disorder	Brintellix Brintellix Brintellix	Psychiatry	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		30/06/2023
MHRA-100706-PIP01-22	METHYLPHENIDATE HYDROCHLORIDE	Treatment of attention-deficit hyperactivity disorder	Not available at present Methylphenidate hydrochloride Methylphenidate hydrochloride Methylphenidate hydrochloride Methylphenidate hydrochloride	Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	Yes		30/06/2023
MHRA-100845-PIP01-23-M02 (update)	CABOTEGRAVIR	Prevention of human immunodeficiency virus (HIV-1) infection	N/A VOCABRIA AND APRETUDE Apretude N/A N/A N/A Apretude Apretude	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	20/06/2023
MHRA-100884-PIP01-23-M01 (update)	SACUBITRIL VALSARTAN	Treatment of Heart failure	Entresto Entresto Entresto Entresto Entresto Entresto Entresto Entresto Entresto Entresto Entresto Entresto Entresto Entresto Entresto Entresto Entresto Entresto Entresto Entresto Entresto Entresto Entresto Entresto Entresto Entresto Entresto Neparvis Neparvis Neparvis Neparvis Neparvis Neparvis Neparvis Neparvis Neparvis Neparvis Neparvis Neparvis Neparvis Neparvis Neparvis Neparvis Neparvis	Cardiovascular Diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	25/05/2023
MHRA-100816-PIP01-22-M01 (update)	crovalimab	Treatment of paroxysmal nocturnal haemoglobinuria Treatment of atypical haemolytic uremic syndrome		Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		25/05/2023
MHRA-100855-PIP01-23-M01 (update)	DOPAMINE HYDROCHLORIDE	Treatment of vascular hypotensive disorders	Neoatricon	Cardiovascular Diseases Neonatology - Paediatric Intensive Care	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	25/05/2023
MHRA-100608-PIP01-22-M01 (update)	mitapivat	Treatment of pyruvate kinase deficiency	PYRUKYND PYRUKYND	Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	07/12/2022
MHRA-100522-PIP01-22-M01 (update)	CABOZANTINIB	Treatment of malignant solid tumours	Cometriq Cabometyx Cabometyx Cometriq	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	07/12/2022
MHRA-100450-PIP01-22-M01 (update)	ALPELISIB	PIK3CA Related Overgrowth Spectrum (PROS)	Piqray Piqray	Other: Congenital, Hereditary, Neonatal Disease and Abnormalities	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	29/07/2022
MHRA-100248-PIP01-21-M01 (update)	RISDIPLAM	Treatment of spinal muscular atrophy	Evrysdi Evrysdi	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	17/05/2022
MHRA-100217-PIP01-21-M01 (update)	ERIBULIN	Treatment of soft tissue sarcoma	Halaven Halaven	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	17/05/2022
MHRA-100049-PIP01-21-M02 (update)	IBRUTINIB	Treatment of mature B-cell neoplasm	Imbruvica Imbruvica Imbruvica Imbruvica Imbruvica Imbruvica Imbruvica Imbruvica Imbruvica Imbruvica Imbruvica Imbruvica Imbruvica Imbruvica Imbruvica	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	17/05/2022
MHRA-100157-PIP01-21-M01 (update)	EXENATIDE	Type 2 diabetes mellitus	Byetta Bydureon Bydureon BCise Byetta Byetta Bydureon Bydureon Byetta Bydureon	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	18/03/2022
MHRA-100039-PIP01-21-M01 (update)	Cotadutide	Treatment of non-alcoholic steatohepatitis (NASH)		Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	17/12/2021

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