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PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Date Published Sort ascending
MHRA-101085-PIP01-23	Humanised IgG1 monoclonal antibody against integrin beta-6 conjugated to monomethyl auristatin E via a valine-citrulline linker	Treatment of non-small cell lung cancer		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	30/04/2024
MHRA-101355-PIP01-24	(3S,10S,14S)-1-[4-[[(2S)-4-carboxy-2-[(2S)-4-carboxy-2-(6-[18F] fluoropyridin-3-amido)butanamido]butanamido]methyl]phenyl]-3-[(naphthalen-2-yl)methyl]-1,4,12-trioxo-2,5,11,13-tetraazahexadecane-10,14,16-tricarboxylic acid ([18F]PSMA-1007)	Visualisation of prostate specific membrane antigen in prostate cancer	Radelumin	Diagnostic Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	30/04/2024
MHRA-100986-PIP02-23	ENCORAFENIB	Treatment of lung cancer	Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	30/04/2024
MHRA-100985-PIP02-23	BINIMETINIB	Treatment of lung cancer	Mektovi Mektovi Mektovi Mektovi Mektovi Mektovi Mektovi Mektovi Mektovi Mektovi	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	30/04/2024
MHRA-101270-PIP01-23	SEMAGLUTIDE	Prevention of cardiovascular events in patients with atherosclerosis	Wegovy Wegovy Wegovy Wegovy Wegovy Wegovy Wegovy Wegovy Wegovy Wegovy Wegovy Wegovy Wegovy Wegovy Wegovy Wegovy Wegovy Wegovy Wegovy Wegovy Wegovy Wegovy Wegovy Wegovy	Endocrinology-Gynaecology-Fertility-metabolism	W: decision granting a waiver in all age groups for the listed condition(s).	No	30/04/2024
MHRA-101090-PIP01-23	tiragolumab	Treatment of hepatocellular carcinoma		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	30/04/2024
MHRA-101059-PIP01-23	[(2R)-2,3-bis[[(Z)-octadec-9-enoyl]oxy]propyl]-trimethylazanium chloride (R-DOTAP chloride) Palmitoyl-KSS-MHGDTPTLHEYMLDLQPETT (HPV-16 E7 1-20) / Palmitoyl-KSS-YMLDLQPETT (HPV-16 E7 11-20) / Palmitoyl-KSS-GQAEPDRAHYNIVTF (HPV-16 E7 43-57) / Palmitoyl-KSS-KKLLMGTLGIVCPICSQKP(HPV-16 E7 82-98) / Palmitoyl-KSS-LLMGTLGIV (HPV-16 E7 82-90) /Palmitoyl-KSS-ELQTTIHDIILECVYCKQQLL (HPV-16 E6 25-45)	Treatment of human papilloma virus (HPV) type 16 positive malignancies		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	30/04/2024
MHRA-100980-PIP01-23	1-((S)-4-((R)-7-(6-amino-4-methyl-3-(trifluoromethyl)pyridin-2-yl)-6-chloro-8-fluoro- 2-(((S)-1-methylpyrrolidin-2-yl)methoxy)quinazolin-4-yl)-3-methylpiperazin-1-yl)prop- 2-en-1-one adipate	Treatment of non-small cell lung cancer		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	30/04/2024
MHRA-100969-PIP01-23	V940 (mRNA-4157), Modified messenger ribonucleic acid encoding individual patient-specific tumour neoantigens	Treatment of lung cancer	Not available at present	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	30/04/2024
MHRA-101287-PIP01-23	SUMATRIPTAN NAPROXEN SODIUM	Treatment of migraine headaches	Suvexx 85 mg/500 mg film-coated tablets FI, DK, HU, NO, SE: Nomigrin EE, LT, LV: Migsun PL: Frimig Duo	Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No	30/04/2024
MHRA-101034-PIP01-23	Belrestotug GSK4428859A	Treatment of lung cancer		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	30/01/2024
MHRA-100978-PIP01-23	Genetically detoxified Pertussis Toxin (PTgen) and Pertussis Filamentous Haemagglutinin (FHA)	Prevention of Pertussis disease	Pertagen Pertagen Pertagen Pertagen aPgen	Vaccines	W: decision granting a waiver in all age groups for the listed condition(s).	No	30/01/2024
MHRA-100858-PIP01-23	sabatolimab	Treatment of myelodysplastic syndromes		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	30/01/2024
MHRA-101030-PIP01-23	Inhibitor of receptor-interacting serine/threonine-protein kinase 1 (RIPK1) (SAR443820)	Treatment of Amyotrophic lateral sclerosis		Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No	30/01/2024
MHRA-100544-PIP01-22-M02 (update)	sebetralstat	Treatment of hereditary angioedema		Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/01/2024
MHRA-100840-PIP01-23-M01 (update)	Odronextamab	Treatment of mature B cell malignancies		Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/01/2024
MHRA-100369-PIP01-21-M02 (update)	MIGALASTAT HYDROCHLORIDE	Treatment of Fabry disease	Galafold 123 mg capsules Galafold Galafold	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/01/2024
MHRA-101073-PIP01-23-M01 (update)	MIRABEGRON	Treatment of idiopathic overactive bladder	BETMIGA MYRBETRIQ / MYRBETRIQ GRANULES	Uro-Nephrology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/01/2024
MHRA-100669-PIP01-22-M02 (update)	RILPIVIRINE EMTRICITABINE TENOFOVIR ALAFENAMIDE	Treatment of human immunodeficiency virus (HIV-1) infection	Odefsey Odefsey Odefsey	Infectious diseases	W: decision granting a waiver in all age groups for the listed condition(s).	No	30/01/2024
MHRA-100512-PIP01-22-M01 (update)	DAPAGLIFLOZIN	Treatment of Type 1 Diabetes Mellitus	Forxiga Forxiga	Endocrinology-Gynaecology-Fertility-metabolism	W: decision granting a waiver in all age groups for the listed condition(s).	No	30/01/2024

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