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.
- Product Monograph
- A Product Monograph (PM) is a factual, scientific document on the drug product that, devoid of promotional material, describes the properties, claims, indications, and conditions of use for the drug, and that contains any other information that may be required for optimal, safe, and effective use of the drug. A PM includes appropriate information respecting the name of the drug, its therapeutic or pharmacologic classification, its actions and/or clinical pharmacology, and its indications and clinical uses.
The monograph also includes contraindications, warnings, precautions, adverse reactions, drug interactions and effects on laboratory tests, symptoms and treatment of overdosage, dosage and administration, storage and stability, pharmaceutical information, dosage forms, pharmacology, toxicology, microbiology, special handling instructions, information on clinical trials, information for the consumer, references, and the dates of the initial printing and current revision.
- Brand Name
- The Brand Name is the proprietary name of the drug under which it is marketed.
- Medicinal Ingredient
- A component that has medicinal properties, and supplies pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.
- The company in whose name the drug submission was filed, whose name appears on the product label, and who has been given approval to sell a drug. Note that the manufacturer is not necessarily the company that fabricated the drug product.
- Paediatric Extension
- Pursuant to subsection C.08.004.1 of the Food and Drug Regulations, a manufacturer of an innovative drug is allowed a period of eight years of market exclusivity after issuance of a Notice of Compliance. An extended period of six months may be added when information regarding paediatric use is provided. Extending the term of data protection in this manner is intended to encourage the submission of paediatric research results to provide health benefits to children. See Health Canada's Guidance Document: Data Protection under C.08.004.1 of the Food and Drug Regulations.
- Therapeutic Classification
- Assigned to the drug product according to its main therapeutic use.
- Is it Indicated in Paediatrics?
- Whether the drug product has been authorized by Health Canada for use in children under 18 years of age.
- Section of the PM that describes situations in which the drug should not be used because the risk outweighs any potential therapeutic benefit. When a "Yes" appears in this column, the contraindication may be either applicable to children, or may be referring to use of the drug in children.
- Warnings and Precautions
- Section of the PM that contains information about all serious effects that may pose a hazard to the patient, as well as precautions to be exercised by the physician or by the patient in order to ensure safe and effective use of the drug.
- Adverse Reactions
- Section of the PM that contains information on all types of adverse drug reactions including those identified during clinical trials and as a result of post-market surveillance.
- Action and Clinical Pharmacology
- Section of the PM which summarizes the salient features of the drug's mechanisms of action, pharmacodynamics and pharmacokinetics. Any clinically significant pharmacokinetic features should also be presented here, including any information on special populations and conditions.
- Clinical Trials
- Section of the PM that contains the pivotal studies in support of the drug's efficacy and safety.
- Date of Revision
- The date located on the first page of the PM which identifies which version of the PM was used to collect the data in this table.
- Control No.
- The 6-digit number located on the first page of the PM which identifies which version of the Product Monograph was used to collect the data in this table.
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: