Notice: Therapeutic Products with Paediatric Labelling
February 12, 2015
Our file Number: 14-114323-793
This Notice serves to inform healthcare professionals and the Canadian public of a report published on Health Canada's website that will provide information on therapeutic products which have paediatric information available in their labelling.
Children ages 0-18 years have unique health and safety needs, and respond differently to health products than the general population. However, because it is often difficult to obtain scientific data on children, many health products are not formulated specifically for use by this population, and may not have sufficient information in their labelling to guide or support their use.
In an effort to bridge this knowledge gap and identify those drug products with data available for the paediatric population, Health Canada is publishing an administrative list of all marketed therapeutic products that have paediatric information related to safety and efficacy available in their labelling. The type of information being captured in this table will describe whether a particular product is authorized for use in children and whether the product's labelling contains paediatric safety information. It also identifies which innovative drugs have been granted an extended period of data protection following the inclusion of results of paediatric clinical trials in their labelling.
The table includes both prescription pharmaceuticals regulated under Division 8 of the Food and Drug Regulations as well as biological drug products and vaccines regulated under Division 4 which contain paediatric information in their Product Monograph (PM).
The Table is an administrative list of drug products and vaccines created on the original date of this notice. The Drug Product Database provides access to the most up-to-date version of the PM for drug products marketed in Canada.
Note: When "Yes" appears in the respective column, it is important to consult the section of the PM to view the exact text.
Any questions or concerns related to a specific drug product listed in the table should be directed to the manufacturer.
Questions or concerns related to this Notice should be directed to the addresses below:
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