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PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Date Published Sort ascending
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-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-100110-PIP02-22	Yellow fever virus, strain vYF-247	Prevention of yellow fever disease		Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	30/06/2023
MHRA-100737-PIP01-22	Clazakizumab	Prevention and treatment of rejection of transplanted kidney		Immunology -Rheumatology-Transplantation	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	30/06/2023
MHRA-100371-PIP01-21	Ex vivo expanded autologous human keratinocytes containing epidermal stem cells genetically modified with a gamma-retroviral (RV) vector expressing the full-length LAMB3 cDNA	Treatment of Junctional Epidermolysis Bullosa (JEB)	HOLOGENE 5	Dermatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	30/06/2023
MHRA-100792-PIP01-22	OBINUTUZUMAB	Prevention of cytokine release syndrome induced by anti CD20/CD3 antibodies	Gazyvaro	Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	30/06/2023
MHRA-100466-PIP01-22	zilovertamab vedotin	Treatment of malignant neoplasms of haematopoietic and lymphoid tissue Treatment of all conditions included in the category of malignant neoplasms (except nervous system, haematopoietic, and lymphoid tissue)	not available at present	Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	30/06/2023
MHRA-100126-PIP01-21-M01 (update)	Adeno-associated viral vector serotype 9 containing the human mini-dystrophin gene	Duchenne Muscular Dystrophy	fordadistrogene movaparvovec	Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	15/06/2023
MHRA-100598-PIP01-22	Cobolimab	Treatment of lung cancer	Not available at present	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	25/05/2023
MHRA-100587-PIP01-22	lusvertikimab	Treatment of Sjögren’s syndrome		Immunology -Rheumatology-Transplantation	W: decision granting a waiver in all age groups for the listed condition(s).	No	25/05/2023

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