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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-101094-PIP01-23	Givinostat	Treatment of Duchenne muscular dystrophy		Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	Yes	Partial Compliance Check Granted	30/04/2024
MHRA-100971-PIP01-23	Sipavibart (AZD3152)	Prevention of coronavirus disease 2019 (COVID-19)		Infectious diseases	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		30/04/2024
MHRA-100689-PIP01-22	Dersimelagon	Treatment of systemic sclerosis		Other: Autoimmune and immune dysfunction diseases	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		30/04/2024
MHRA-100680-PIP01-22	Influenza recombinant H7 haemagglutinin	Prevention of influenza infection		Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		30/04/2024
MHRA-100103-PIP01-21	Rozanolixizumab	Treatment of myelin oligodendrocyte glycoprotein antibody-associated disease	Not available at present	Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		30/04/2024
MHRA-100920-PIP01-23	Pneumococcal Polysaccharide Serotype 3 – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 6A – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 7F – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 19A – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 22F – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 33F – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 8 – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 9N – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 10A – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 11A – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 12F – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 17F – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 15A – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 15C – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 16F – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 23A – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 23B – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 24F – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 31 – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 35B – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 20A – Diphtheria CRM197 Conjugate	Prevention of disease caused by Streptococcus pneumoniae		Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		30/04/2024
MHRA-100594-PIP01-22	N-[4-(6-fluoro-3,4-dihydro-1H-isoquinolin-2-yl)-2,6-dimethyl-phenyl]-3,3-dimethylbutanamide	Treatment of focal onset seizures		Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		30/04/2024
MHRA-101232-PIP01-23	palopegteriparatide	Treatment of hypoparathyroidism	Yorvipath Yorvipath	Endocrinology-Gynaecology-Fertility-metabolism	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		30/04/2024
MHRA-101230-PIP01-23	teprotumumab	Treatment of thyroid eye disease	Not available at present TEPEZZA	Ophthamology	W: decision granting a waiver in all age groups for the listed condition(s).	No		30/04/2024
MHRA-101122-PIP01-23	ENFORTUMAB VEDOTIN	Treatment of head and neck epithelial malignant neoplasms	Padcev Padcev Padcev	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		30/04/2024
MHRA-101100-PIP01-23	Derivative of a benzoimidazole substituted pyrimidine (PF-07220060)	Treatment of breast malignant neoplasms		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		30/04/2024
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

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