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PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Date Published Sort ascending
MHRA-101468-PIP01-24	DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE baxdrostat	Treatment of Chronic Kidney Disease		Uro-Nephrology	W: decision granting a waiver in all age groups for the listed condition(s).	No	03/10/2024
MHRA-100239-PIP01-21-M01 (update)	Multivalent pneumococcal polysaccharide conjugate to carrier protein	Prevention of disease caused by Streptococcus pneumoniae	Not available at present	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	03/10/2024
MHRA-101422-PIP01-24	Single-stranded 5' capped mRNA encoding the HAs of the influenza virus strains A/H1N1, A/H3N2, and B/Victoria and the N-terminal domain (NTD) and receptor binding domain (RBD) of the SARS-CoV-2 spike glycoprotein (mRNA-1083)	Prevention of influenza and coronavirus disease 2019 (COVID-19)		Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	03/10/2024
MHRA-101378-PIP01-24	UPADACITINIB	Treatment of hidradenitis suppurativa	Rinvoq	Dermatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	03/10/2024
MHRA-100428-PIP01-22-M02 (update)	LENACAPAVIR SODIUM	Treatment of human immunodeficiency virus (HIV-1) infection	Sunlenca Sunlenca	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	03/10/2024
MHRA-101431-PIP01-24	SODIUM PHENYLBUTYRATE Ursodoxicoltaurine	Treatment of progressive supranuclear palsy	Relyvrio Albrioza	Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No	03/10/2024
MHRA-101388-PIP01-24-M01 (update)	DARIDOREXANT HYDROCHLORIDE	Treatment of insomnia.	QUVIVIQ	Psychiatry	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	03/10/2024
MHRA-101326-PIP01-24	Human IgG4 monoclonal antibody against BCMA and CD3	Treatment of multiple myeloma	Not available at present	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	03/10/2024
MHRA-101338-PIP01-24	elinzanetant	Treatment of vasomotor symptoms caused by endocrine therapy related to breast cancer		Endocrinology-Gynaecology-Fertility-metabolism	W: decision granting a waiver in all age groups for the listed condition(s).	No	03/10/2024
MHRA-101186-PIP01-23	FARICIMAB	Treatment of choroidal neovascularisation secondary to pathologic myopia	Vabysmo Vabysmo	Ophthamology	W: decision granting a waiver in all age groups for the listed condition(s).	No	03/10/2024
MHRA-101324-PIP01-23-M01 (update)	REGADENOSON	Diagnosis of myocardial perfusion disturbances	Rapiscan Rapiscan Rapiscan	Cardiovascular Diseases Diagnostic	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	03/10/2024
MHRA-101288-PIP01-23	Interleukin-2 Interleukin-1 beta, human Granulocyte colony-stimulating factor Tumor necrosis factor-alpha Interferon gamma	Treatment of squamous cell carcinoma of the head and neck (SCCHN)	Multikine	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	03/10/2024
MHRA-101007-PIP01-23	tiragolumab ATEZOLIZUMAB	Treatment of lung carcinoma (non-small cell carcinoma)	Not available at present	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	03/10/2024
MHRA-100968-PIP01-23	dirloctocogene samoparvovec	Treatment of congenital haemophilia A	Not available at present	Haematology-Hemostaseology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	03/10/2024
MHRA-101204-PIP01-23	Ravulizumab (ALXN1210)	Prevention of kidney injury in high-risk patients with chronic kidney disease undergoing cardiopulmonary bypass	Ultomiris Ultomiris Ultomiris Ultomiris	Uro-Nephrology	W: decision granting a waiver in all age groups for the listed condition(s).	No	03/10/2024
MHRA-100494-PIP01-22-M02 (update)	NIVOLUMAB	Treatment of malignant neoplasms of lymphoid tissue Treatment of malignant neoplasms of the central nervous system	OPDIVO OPDIVO OPDIVO OPDIVO	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	03/10/2024
MHRA-100502-PIP01-22-M02 (update)	Recombinant Influenza Hemagglutinin-strain A (H1N1 subtype) Recombinant Influenza Hemagglutinin-strain A (H3N2 subtype) Recombinant Influenza Hemagglutinin-strain B (Victoria lineage) Recombinant Influenza Hemagglutinin-strain B (Yamagata lineage)	Prevention of influenza disease	Supemtek	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	03/10/2024
MHRA-101127-PIP01-23	Zimberelimab	Treatment of lung cancer		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	03/10/2024
MHRA-101126-PIP01-23	Zimberelimab	Treatment of gastric and gastroesophageal junction adenocarcinoma. Treatment of oesophageal carcinoma.		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	03/10/2024
MHRA-101400-PIP01-24	nirogacestat hydrobromide	Treatment of soft tissue sarcoma	Not yet available in the United Kingdom (Ogsiveo in the United States and European Union). Ogsiveo	Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	03/10/2024

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