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PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area Sort descending	Decision Type	Compliance Check	Date Published
MHRA-100347-PIP01-21	Respiratory Syncytial Virus Stabilised Prefusion F Subunit Vaccine (RSVpreF, PF-06928316)	Prevention of lower respiratory track disease caused by RSV via maternal immunisation.	Not available at present	Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	02/11/2022
MHRA-100242-PIP01-21	Respiratory Syncytial Virus Stabilised Prefusion F Subunit Vaccine (RSVpreF, PF-06928316)	Prevention of lower respiratory tract disease caused by respiratory syncytial virus.		Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	07/12/2022
MHRA-100030-PIP01-21	9-valent vaccine consisting of the O-antigen polysaccharides of the extraintestinal pathogenic Escherichia coli (ExPEC) serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B and O75 bioconjugated to the carrier exoprotein A (EPA), a genetically detoxified protein from Pseudomonas aeruginosa (ExPEC9V)	Prevention of infections caused by extraintestinal pathogenic Escherichia coli (ExPEC)		Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	07/12/2022
MHRA-100110-PIP02-22	Yellow fever virus, strain vYF-247	Prevention of yellow fever disease		Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	30/06/2023
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-100796-PIP01-22	Single-stranded 5' capped mRNA encoding the Respiratory syncytial virus glycoprotein F stabilized in the prefusion conformation	Prevention of lower respiratory tract illness (LRTI) caused by respiratory syncytial virus (RSV)	Not available at present	Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	19/12/2023
MHRA-100096-PIP01-21	Live, attenuated, dengue virus, serotype 1 (DENV1) Live, attenuated, chimeric dengue virus, serotype 2 (DENV2) Live, attenuated, dengue virus, serotype 3 (DENV3) Live, attenuated, dengue virus, serotype 4 (DENV4)	Prevention of dengue disease	Not available at present	Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	19/12/2023
MHRA-100754-PIP01-22	Live-attenuated La Reunion strain of chikungunya virus	Prevention of chikungunya virus disease		Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	19/12/2023
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-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-100673-PIP01-22	Fidrisertib	Treatment of fibrodysplasia ossificans progressiva		Other: Musculoskeletal	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	19/12/2023
MHRA-100678-PIP01-22	Humanised IgG2 monoclonal antibody against interleukin-6 (RO7200220)	Treatment of uveitic macular oedema	Not available at present	Ophthamology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	19/12/2023
MHRA-100150-PIP01-21	AZITHROMYCIN	Prevention of bronchopulmonary dysplasia (BPD)		Pneumology - Allergology Neonatology - Paediatric Intensive Care	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/05/2022
MHRA-100106-PIP01-21	3,5-diamino-6-chloro-N-(N-(4-(4-(2-(hexyl((2S,3R,4R,5R)-2,3,4,5,6-pentahydroxyhexyl)amino)ethoxy)phenyl)butyl)-carbamimidoyl)pyrazine-2-carboxaminde sodium chloride solution 4.2% (w/v)	Treatment of primary ciliary dyskinesia		Pneumology - Allergology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/05/2022
MHRA-100230-PIP01-21	Thienopyrimidine Derivative	Treatment of fibrosing interstitial lung disease		Pneumology - Allergology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/05/2022
MHRA-100062-PIP01-21	(14S)-8-[3-(2-{dispiro[2.0.2^(4).1^(3)]heptan-7-yl}ethoxy)-1H-pyrazol-1-yl]-12,12-dimethyl-2lambda^(6)-thia-3,9,11,18,23-penta-azatetracyclo[17.3.1.1^(11,14).0^(5,10)]tetracosa-1(22),5,7,9,19(23),20-hexaene-2,2,4-trione calcium salt hydrate TEZACAFTOR DEUTIVACAFTOR	Treatment of Cystic Fibrosis		Pneumology - Allergology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	29/07/2022
MHRA-100305-PIP01-21	Single chain urokinase plasminogen activator (scuPA)	Treatment of pleural effusion		Pneumology - Allergology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	29/07/2022
MHRA-100315-PIP01-21	Brensocatib	Treatment of non‐cystic fibrosis bronchiectasis		Pneumology - Allergology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	29/07/2022
MHRA-100141-PIP01-21	BENRALIZUMAB	Treatment of Eosinophilic Granulomatosis with Polyangitis (EGPA)	FASENRA FASENRA FASENRA FASENRA FASENRA FASENRA PEN	Pneumology - Allergology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	27/09/2022

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