Information (PI) about the prevention of nasopharyngeal carriage of S. pneumoniae serotypes. Regulatory status The product received initial Australian Register of Therapeutic Goods (ARTG) Registration on 29 March 2010. An extension of indication (EOI) to include children and adolescents aged 6-17 years was approved in the European Union (EU) in December 2012 and in the USA in January 2013. The inclusion of information about nasopharyngeal carriage in the EU Summary of Product Characteristics (SmPC) was approved in November 2012. The approved text in the EU SmPC contains results from the ACTIV surveillance study conducted in France as a postmarketing requirement. At the time of writing this overview, no submission has been made in the USA to include nasopharyngeal carriage data in US Prescribing Information. Applications for the EOI and the inclusion of information about nasopharyngeal carriage in product labelling are under review by Health Canada. The following table summarises the international regulatory status of this product. Table 1. International regulatory status of Prevenar 13 Market Variation to Indication Status USA Invasive Disease Pediatric 6 weeks - Approved 24/2/10 5 years Otitis Media Pneumonia Pediatric 6 trial - 5 years Invasive Disease Adult 50+ Approved 30/12/11 Pneumonia-adult Europe Invasive disease, adult aged from 18 Approved 09/07/13 to 49 Years Invasive Disease Pediatric 6 - 5 Approved 9/12/09 years Otitis Media Pneumonia Pediatric 6 weeks - 5 years Invasive disease, adult aged 50 years Approved 24/10/11 and older Canada Invasive disease, pediatric aged from Approved 21/12/09 6 Weeks to 5 Years Invasive Disease Adult 50+ Approved 13/01/12 Invasive disease, aged from 18 Under review to 49 Years
Information (PI) about the prevention of nasopharyngeal carriage of S. pneumoniae serotypes. Regulatory status The product received initial Australian Register of Therapeutic Goods (ARTG) Registration on 29 March 2010. An extension of indication (EOI) to include children and adolescents aged 6-17 years was approved in the European Union (EU) in December 2012 and in the USA in January 2013. The inclusion of information about nasopharyngeal carriage in the EU Summary of Product Characteristics (SmPC) was approved in November 2012. The approved text in the EU SmPC contains results from the ACTIV surveillance study conducted in France as a postmarketing requirement. At the time of writing this overview, no submission has been made in the USA to include nasopharyngeal carriage data in US Prescribing Information. Applications for the EOI and the inclusion of information about nasopharyngeal carriage in product labelling are under review by Health Canada. The following table summarises the international regulatory status of this product. Table 1. International regulatory status of Prevenar 13 Market Variation to Indication Status USA Invasive Disease Pediatric 6 weeks - 5 years Otitis Media Pneumonia Pediatric 6 - 5 years Approved 24/2/10 Invasive Disease Adult 50+ Pneumonia-adult Approved 30/12/11 Europe Invasive disease, adult aged from 18 to 49 Years Approved 09/07/13 Invasive Disease Pediatric 6 - 5 years Otitis Media Pneumonia Pediatric 6 weeks - 5 years Approved 9/12/09 Invasive disease, adult aged 50 years and older Approved 24/10/11 Canada Invasive disease, pediatric aged from 6 Weeks to 5 Years Approved 21/12/09 Invasive Disease Adult 50+ Approved 13/01/12 Invasive disease, aged from 18 to 49 Years Under review trial