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PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check Sort ascending	Date Published
MHRA-100424-PIP01-22	zilebesiran sodium	Treatment of hypertension		Cardiovascular Diseases	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	24/08/2023
MHRA-100966-PIP01-23	COVID-19 Vaccine (recombinant, adjuvanted)	Prevention of coronavirus disease 2019 (COVID-19)	Not available at present	Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	24/08/2023
MHRA-100578-PIP01-22	Cagrilintide SEMAGLUTIDE	Treatment of obesity	Not available at present	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-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-100164-PIP01-21-M02 (update)	Nirmatrelvir RITONAVIR	Treatment of coronavirus disease 2019 (COVID-19) Prevention of Coronavirus Disease 2019 (COVID-19)	Paxlovid Paxlovid Paxlovid Paxlovid Paxlovid Paxlovid	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	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-100130-PIP01-21-M02 (update)	BUPIVACAINE	Postsurgical analgesia	EXPAREL liposomal EXPAREL EXPAREL EXPAREL EXPAREL	Pain	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-100351-PIP01-21-M01 (update)	DOLUTEGRAVIR RILPIVIRINE	Treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection.	JULUCA JULUCA JULUCA JULUCA JASUPA Juluca 50mg/25mg film-coated tablets JULUCA JULUCA JULUCA JULUCA JULUCA JULUCA JULUCA JULUCA JULUCA JULUCA JULUCA JULUCA JULUCA	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	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-100475-PIP01-22-M01 (update)	Neisseria meningitidis serogroup A polysaccharide conjugated to tetanus toxoid Neisseria meningitidis serogroup C polysaccharide conjugated to tetanus toxoid Neisseria meningitidis serogroup Y polysaccharide conjugated to tetanus toxoid Neisseria meningitidis serogroup W polysaccharide conjugated to tetanus toxoid	Prevention of invasive meningococcal disease	MenQuadfi MenQuadfi	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/06/2023
MHRA-100720-PIP01-22-M01 (update)	Gepotidacin	Treatment of uncomplicated urinary tract infections		Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/06/2023
MHRA-100714-PIP01-22-M01 (update)	Gepotidacin	Treatment of uncomplicated urogenital gonorrhoea (GC)		Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/06/2023
MHRA-100709-PIP01-22-M01 (update)	rozanolixizumab	Treatment of myasthenia gravis		Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/06/2023
MHRA-100447-PIP01-22-M02 (update)	Tirzepatide	Treatment of Type 2 Diabetes Mellitus	Mounjaro Mounjaro	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/06/2023
MHRA-100349-PIP01-21-M02 (update)	Rezafungin acetate	Treatment of invasive candidiasis	Rezzayo 200 mg powder for concentrate for solution for infusion	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/06/2023

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