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PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Compliance outcome	Date Published Sort ascending
MHRA-100721-PIP01-22	Recombinant fusion protein linking iduronate 2-sulfatase to engineered Fc with binding site for transferrin receptor (DNL310)	Treatment of mucopolysaccharidosis II (Hunter syndrome)		Endocrinology-Gynaecology-Fertility-metabolism	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		24/08/2023
MHRA-100641-PIP01-22-M02 (update)	DURVALUMAB	Treatment of all conditions included in the category of malignant neoplasms (except central nervous system, haematopoietic and lymphoid tissue)	IMFINZI IMFINZI	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		14/08/2023
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-100740-PIP01-22	Xevinapant	Treatment of head and neck epithelial malignant neoplasms	Not available at present	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		30/06/2023
MHRA-100148-PIP01-21-M03 (update)	LENVATINIB MESILATE	Treatment of all conditions included in the category of malignant neoplasms except haematopoietic and lymphoid tissue neoplasms, papillary thryoid cancer, follicular thyroid cancer and osteosarcoma	Lenvima Lenvima Kisplyx Kisplyx	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/06/2023
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-100717-PIP01-22-M01 (update)	RISDIPLAM	Treatment of spinal muscular atrophy	Evrysdi Evrysdi Evrysdi Evrysdi Evrysdi Evrysdi Evrysdi Evrysdi	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/06/2023
MHRA-100029-PIP01-21-M01 (update)	RECOMBINANT REPLICATION-INCOMPETENT ADENOVIRUS SEROTYPE 26 VECTOR ENCODING THE SARS-COV-2 SPIKE PROTEIN PER.C6 CELL LINE COVID-19 vaccine (Ad26.COV2-S [recombinant])	Prevention of coronavirus disease-2019 (COVID-19)	COVID-19 vaccine Janssen Jcovden (previously COVID-19 Vaccine Janssen)	Infectious diseases Vaccines	W: decision granting a waiver in all age groups for the listed condition(s).	No		30/06/2023
MHRA-100699-PIP01-22-M01 (update)	DIROXIMEL FUMARATE	Treatment of Multiple Sclerosis	Vumerity Vumerity Vumerity	Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No		30/06/2023
MHRA-100733-PIP01-22	Botulinum toxin type E	Treatment of skin wrinkling		Dermatology	W: decision granting a waiver in all age groups for the listed condition(s).	No		30/06/2023
MHRA-100684-PIP01-22	Clazakizumab	Prevention of cardiovascular events in patients with atherosclerosis	Not available at present	Cardiovascular Diseases	W: decision granting a waiver in all age groups for the listed condition(s).	No		30/06/2023
MHRA-100323-PIP01-21-M02 (update)	SAXAGLIPTIN	Treatment of Type 2 Diabetes Mellitus	Onglyza Onglyza Onglyza Onglyza Onglyza	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		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-100250-PIP01-21-M02 (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		30/06/2023
MHRA-100645-PIP01-22-M01 (update)	AMIKACIN SULFATE	Treatment of Pseudomonas aeruginosa lung infection/colonisation in cystic fibrosis patients Treatment of non-tuberculous mycobacterial lung infection	Arikayce Arikayce Arikayce liposomal	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/06/2023
MHRA-100535-PIP01-22-M02 (update)	FLUTICASONE FUROATE UMECLIDINIUM BROMIDE VILANTEROL TRIFENATATE	Treatment of asthma	Trelegy Ellipta Trelegy Ellipta Trelegy Ellipta/ Elebrato Ellipta Trelegy Ellipta	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/06/2023
MHRA-100805-PIP01-22-M01 (update)	ATIDARSAGENE AUTOTEMCEL	Treatment of metachromatic leukodystrophy (MLD)	Libmeldy Libmeldy Libmeldy	Other: Lysosomal storage Disorder	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/06/2023
MHRA-100802-PIP01-22-M01 (update)	roxadustat	Treatment of anaemia due to chronic disorders	EVRENZO EVRENZO EVRENZO EVRENZO EVRENZO EVRENZO EVRENZO EVRENZO	Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/06/2023
MHRA-100727-PIP01-22-M01 (update)	ALPELISIB	Treatment of PIK3CA related overgrowth spectrum	Vijoice Piqray Vijoice	Other: Congenital, Hereditary, Neonatal Disease and Abnormalities	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/06/2023
MHRA-100716-PIP01-22-M01 (update)	RUXOLITINIB PHOSPHATE	Treatment of chronic Graft versus Host Disease	Jakavi Jakavi Jakavi Jakavi Jakavi Jakavi Jakavi Jakavi Jakavi Jakavi Jakavi Jakavi	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	30/06/2023

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