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PIPS Search Results
PIP Number	Active Substance Sort descending	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Compliance outcome	Date Published
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-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-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-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-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-100558-PIP01-22	milvexian	Prevention of thromboembolism in patients with cardiovascular disease	Not available at present	Cardiovascular Diseases	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		30/04/2024
MHRA-100562-PIP01-22	strontium-82 chloride/ rubidium-82 chloride	Visualisation of myocardial perfusion for diagnostic purposes	Ruby-Fill Ruby-Fill Ruby-Fill	Cardiovascular Diseases Diagnostic	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024
MHRA-100698-PIP01-22	Nemvaleukin Alfa	Treatment of all conditions included in the category of malignant neoplasms (except CNS, haematopoietic and lymphoid tissue) Treatment of malignant neoplasms of the lymphoid tissue		Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		30/04/2024
MHRA-100789-PIP01-22	Fazirsiran	Treatment of congenital alpha-1 antitrypsin deficiency	Not available at present	Gastroenterology-Hepatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		30/04/2024
MHRA-100797-PIP01-22	Single-stranded 5' capped mRNA encoding the HAs of the influenza virus strains A and B (mRNA-1010)	Prevention of influenza disease	Not available at present	Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		30/04/2024
MHRA-100913-PIP01-23	mRNA that encodes for the NTD and RBD epitopes of the spike glycoprotein of SARS-CoV-2 (mRNA-1283)	Prevention of coronavirus disease 2019 (COVID-19)	Not available at present	Infectious diseases Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		30/04/2024
MHRA-101115-PIP01-23	Sodium ({(2S)-1,4-bis[2-(4-chloro-3-fluorophenoxy)acetamido]bicyclo[2.2.2]octan-2-yl}oxy)methyl hydrogen phosphate-2-amino-2-(hydroxymethyl)propane-1,3-diol (1/1/1)	Treatment of Amyotrophic lateral sclerosis	Not available at present	Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No		30/04/2024
MHRA-101118-PIP01-23	5’-capped mRNA encoding HPV16 oncoprotein E6 5’-capped mRNA encoding HPV16 oncoprotein E7	Treatment of head and neck squamous cell carcinoma	Not available at present	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		30/04/2024
MHRA-100301-PIP05-23	Nipocalimab	Treatment of Idiopathic inflammatory myopathies		Immunology -Rheumatology-Transplantation	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		30/04/2024
MHRA-101008-PIP01-23-M01 (update)	AMBRISENTAN	Pulmonary Arterial Hypertension	Volibris Volibris	Cardiovascular Diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024
MHRA-101044-PIP01-23-M01 (update)	INCLISIRAN SODIUM	Treatment of elevated cholesterol	Leqvio Leqvio Leqvio Leqvio	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024
MHRA-100297-PIP01-21-M03 (update)	Human, recombinant, non-fucosylated IgG1k monoclonal antibody targeting OX-40 receptor on activated T cells (rocatinlimab)	Treatment of atopic dermatitis		Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024
MHRA-100485-PIP01-22-M02 (update)	AMG 176 (4S,7aR,9aR,10S,11E,14S,15R)-6'-chloro-10-methoxy-14,15-dimethyl-3',4',7a,8,9,9a,10,13,14,15-decahydro-2'H,7H-spiro[1,19-ethenocyclobuta[i][1,4]oxazepino[3,4f][1,2,7]thiadiazacyclohexadecine-4,1'-naphthalen]-18(17H)-one 16,16-dioxide	Treatment of acute myeloid leukaemia	Tapotoclax	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024
MHRA-100989-PIP01-23-M01 (update)	DERMATOPHAGOIDES FARINAE DERMATOPHAGOIDES PTERONYSSINUS	Treatment of asthma Treatment of allergic rhinitis	ACARIZAX and associated names ACARIZAX ACARIZAX ACARIZAX ACARIZAX AMITEND ACARIZAX AITARO ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACCARIZAX	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		30/04/2024
MHRA-101212-PIP01-23-M01 (update)	CEFEPIME DIHYDROCHLORIDE MONOHYDRATE enmetazobactam	Treatment of infections caused by gram-negative organisms	EXBLIFEP	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	30/04/2024

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