Appendix G Product Monograph Template - Notice of Compliance with Conditions

[Title Page]

Product Monograph

<Scheduling Symbol> <BRAND NAME>

<Proper name>

<Dosage Form(s) and Strength>

<Pharmaceutical standard (if applicable)>

<Therapeutic Classification>

<Brand Name> , < indicated for <...>, has been issued marketing authorization with conditions, pending the results of studies to verify its clinical benefit. Patients should be advised of the nature of the authorization."

<Sponsor Name>
<Sponsor Address>

Date of Preparation:
<MON DD, YYYY>
or
Date of Revision:
<MON DD, YYYY>

This product has been approved under the Notice of Compliance with Conditions (NOC/c) policy for one or all of its indicated uses.

What is a Notice of Compliance with Conditions (NOC/c)?

An NOC/c is a form of market approval granted to a product on the basis of promising evidence of clinical effectiveness following review of the submission by Health Canada.

Products approved under Health Canada's NOC/c policy are intended for the treatment, prevention or diagnosis of a serious, life-threatening or severely debilitating illness. They have demonstrated promising benefit, are of high quality and possess an acceptable safety profile based on a benefit/risk assessment. In addition, they either respond to a serious unmet medical need in Canada or have demonstrated a significant improvement in the benefit/risk profile over existing therapies. Health Canada has provided access to this product on the condition that sponsors carry out additional clinical trials to verify the anticipated benefit within an agreed upon time frame.

What will be different about this Product Monograph?

The following Product Monograph will contain boxed text at the beginning of each major section clearly stating the nature of the market authorization. Sections for which NOC/c status holds particular significance be will be identified in the left margin by the symbol NOC/c. These sections may include, but are not limited to, the following:

  • Indications and Clinical Uses;
  • Action;
  • Warnings and Precautions;
  • Adverse Reactions;
  • Dosage and Administration; and
  • Clinical Trials.

Adverse Drug Reaction Reporting and Re-Issuance of the Product Monograph

Health care providers are encouraged to report Adverse Drug Reactions associated with normal use of these and all drug products to Health Canada's Health Product Safety Information Division at 1-866-234-2345. The Product Monograph will be re-issued in the event of serious safety concerns previously unidentified or at such time as the sponsor provides the additional data in support of the product's clinical benefit. Once the latter has occurred, and in accordance with the NOC/c policy, the conditions associated with market authorization will be removed.

Table of Contents

[To update, right-click anywhere in the Table of Contents and select "Update Field", "Update entire table", click OK.]

<PROPRIETARY OR BRAND NAME>

< Proper name >

Part I: Health Professional Information

<Brand Name> , indicated for <...>, has been issued marketing authorization with conditions, pending the results of studies to verify its clinical benefit. Patients should be advised of the nature of the authorization.

Summary product information

Route of Administration Pharmaceutical Form/Strength Clinically Relevant Nonmedicinal Ingredients
< oral> <tablet 5 mg, 10 mg> <ethanol, gluten, etc>
For a complete listing see Dosage Forms, Composition and Packaging section.

Indications and clinical use

<Brand Name (proper name)> is indicated for:

  • treatment of <text>
  • prevention of <text>
  • diagnosis of <text>

[Brief discussion of any promising clinical information - if applicable]

[Distribution restrictions - if applicable]

[When the product is not recommended - if applicable]

Geriatrics (> x years of age):
<text>

Pediatrics (x - y years of age) or (< years of age):
<text>

Contraindications

  • Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see the Dosage Forms, Composition and Packaging section of the product monograph. [if applicable]
  • <text>
  • <text>

Warnings and precautions

Serious Warnings and Precautions
[Clinically significant or serious life-threatening warnings should be placed in the warning box.  Generally not to exceed 20 lines]

  • <text>
  • <text>

headings to be included as applicable]
General
<text>

Carcinogenesis and Mutagenesis
<text>

Cardiovascular
<text>

Dependence/Tolerance
<text>

Ear/Nose/Throat
<text>

Endocrine and Metabolism
<text>

Gastrointestinal
<text>

Genitourinary
<text>

Hematologic
<text>

Hepatic/Biliary/Pancreatic
<text>

Immune
<text>

Neurologic
<text>

Ophthalmologic
<text>

Peri-Operative Considerations
<text>

Psychiatric
<text>

Renal
<text>

Respiratory
<text>

Sensitivity/Resistance
<text>

Sexual Function/Reproduction
<text>

Skin
<text>

Special Populations:

Pregnant Women:  <text>
[The extent of exposure in pregnancy during clinical trials should be included:
Wide: > 1000 pregnancies
Limited: < 1000 pregnancies
Very Limited: individual cases only
No experience]

Nursing Women: <text>

Pediatrics (x - y years of age) or (< years of age): <text>

Geriatrics (> x years of age): <text>

Monitoring and Laboratory Tests
<text>

Adverse reactions

Adverse Drug Reaction Overview
[An overview of the ADR information that may affect prescribing decisions. It should contain: serious and important ADRs; the most frequent ADRs; and ADRs that most commonly result in clinical intervention.]

Clinical Trial Adverse Drug Reactions

Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates.

[Include description of data sources]

Table <#> -  <Title of Table>
<drug name>
n= <#>
(%)
<placebo>
n= <#>
(%)
Digestive [use MedDRA terms for headings, as applicable]
<text>
<text>
Gastrointestinal
<text>

[Narrative to follow table to explain or supplement the information provided in the table]

Less Common Clinical Trial Adverse Drug Reactions (<1%)
[Presented as a list and categorized by body system]
Cardiovascular: <text>
Digestive: <text>
Gastrointestinal: <text>

Abnormal Hematologic and Clinical Chemistry Findings
<table>

Post-Market Adverse Drug Reactions
<narrative>

Drug interactions

Serious Drug Interactions

[Serious, life-threatening drug interactions should be highlighted in this box. Not to exceed 20 lines].

  • <text>
  • <text>

Overview
<narrative>
[should include the following information: interactions suspected based on the pharmacokinetic or pharmacologic profile of the drug (e.g., cytochrome P450 interactions); drug class statements if the interaction has not yet been documented, but would be clinically significant; potential interaction with alcohol]

Drug-Drug Interactions

Table <# >- Established or Potential Drug-Drug Interactions
<Proper name> Reference Effect Clinical comment
< drug name> <level of evidence, see legend> 9 <drug A> conc [Caution is warranted and therapeutic concentration monitoring is recommended]

Legend: C = Case Study, CT = Clinical Trial, T = Theoretical

Drug-Food Interactions
<narrative>

Drug-Herb Interactions
<narrative>

Drug-Laboratory Interactions
<narrative>

Drug-Lifestyle Interactions
<narrative>

Dosage and administration

Dosing Considerations
[include all situations that may affect dosing of the drug]

  • <text>
  • <text>

Recommended Dose and Dosage Adjustment
[Include for each indication, route of administration or dosage form]
<narrative>

Missed Dose
<narrative>

Administration
<narrative>

Reconstitution:

  • Oral Solutions : <text>
Parenteral Products:
Vial Size Volume of Diluent to be Added to Vial Approximate Available Volume Nominal Concentration per mL

<any specific precautions, storage periods and incompatibilities>

Overdosage

<narrative>

Action and clinical pharmacology

Mechanism of Action
<narrative>
[For anti-infective products: a brief description of action against micro-organisms]

Pharmacodynamics
<narrative>

Pharmacokinetics

Table <#> Summary of <proper name>'s Pharmacokinetic Parameters in a <specific patient population>
Cmax t½ (h) AUC0-4 Clearance Volume of distribution
Single dose mean

Absorption: <text>

Distribution: <text>

Metabolism: <text>

Excretion: <text>

Special Populations and Conditions: [as applicable]

Pediatrics: <text>

Geriatrics: <text> 

Gender: <text>

Race: <text>

Hepatic Insufficiency: <text>

Renal Insufficiency: <text>

Genetic Polymorphism: <text>

Storage and Stability
<narrative>

Special Handling Instructions
<narrative>

Dosage Frms, Composition and Packaging
<narrative>

Part II: Scientific information

<Brand Name>, indicated for <...>, has been issued marketing authorization with conditions, pending the results of studies to verify its clinical benefit. Patients should be advised of the nature of the authorization.

Pharmaceutical Information

Drug Substance

  • Proper name: <text>
  • Chemical name: <text>
  • Molecular formula and molecular mass: <text>
  • Structural formula: <image>
  • Physicochemical properties: <text>

Clinical Trials

Study demographics and trial design

Table <#>- Summary of patient demographics for clinical trials in specific indication
Study # Trial design Dosage, route of administration and duration Study subjects (n=number) Mean age (Range) Gender

[Provide a brief narrative describing the demographic characteristics of the study population].

Study results

Table <#>- Results of study <#> in specific indication
Primary Endpoints Associated value and statistical significance for Drug at specific dosages Associated value and statistical significance for Placebo or active control

[Comparative Bioavailability Studies (if required).  See format, see Standard Template.]

Detailed Pharmacology

<narrative>

Microbiology

<narrative>

Toxicology

[numbered list]

Part III: Consumer Information

<Brand Name >, for use in/as <..>,  has been approved with conditions, pending the results of studies to verify its clinical benefit. For more information, patients are advised to contact their health care provider.

What is a Notice of Compliance with Conditions (NOC/c)?
An NOC/c is a form of market approval granted to a product on the basis of promising evidence of clinical effectiveness following review of the submission by Health Canada.

Products approved under Health Canada's NOC/c policy are intended for the treatment, prevention or diagnosis of a serious, life-threatening or severely debilitating illness. They have demonstrated promising benefit, are of high quality and possess an acceptable safety profile based on a benefit/risk assessment. In addition, they either respond to a serious unmet medical need in Canada or have demonstrated a significant improvement in the benefit/risk profile over existing therapies. Health Canada has provided access to this product on the condition that sponsors carry out additional clinical trials to verify the anticipated benefit within an agreed upon time frame.

<Brand name>
<Proper Name>

This leaflet is part III of a three-part "Product Monograph" published when <brand name> was approved for sale in Canada and is designed specifically for Consumers. This leaflet is a summary and will not tell you everything about <brand name>. Contact your doctor or pharmacist if you have any questions about the drug.

About this medication

What the medication is used for:
<narrative> and/or

  •    <text>
  •    <text>

What it does:
<text>

When it should not be used:
<text>

What the medicinal ingredient is:
<proper name>

What the important nonmedicinal ingredients are:
<alphabetical listing>
For a full listing of nonmedicinal ingredients see Part 1 of the product monograph.

What dosage forms it comes in:
<dosage form(s) and strength(s)>

Warnings and precautions

Serious Warnings and Precautions

  • <text>
  • <text>

BEFORE you use <brand name> talk to your doctor or pharmacist if:

  • <Activities (Warnings and Precautions, e,g, under Occupational Hazards) >
  • <Current conditions  (Contraindications, Warnings and Precautions)>
  • <Past diseases (Contraindications, Warnings and Precautions)>
  • <Reproductive issues (Contraindications, Warnings and Precautions)>
  • <Anticipated medical procedures (Warnings and Precautions)>
  • <Contraindicated or interacting drugs (Contraindications, Drug Interactions)>
  • <Any allergies to this drug or its ingredients or components of the container (Contraindications)>

Interactions with this medication

Drugs that may interact with <brand name> include: <text> .

Proper use of this medication

Usual dose:
<text>

Overdose
<text>

Missed Dose:
<text>

Side effects and what to do about them

<text>

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor or pharmacist Stop taking drug and call your doctor or pharmacist
Only if severe In all cases
Common <symptom / effect>
<symptom / effect>
 
Uncommon <symptom / effect>
<symptom / effect>
 

This is not a complete list of side effects.  For any unexpected effects while taking <Brand Name>, contact your doctor or pharmacist.

How to store it

<text>

Reporting Suspected Side Effects

To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs .  If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:

toll-free telephone: 866-234-2345
toll-free fax 866-678-6789
By email: cadrmp@hc-sc.gc.ca

By regular mail:
National AR Centre
Marketed Health Products Safety and Effectiveness
Information Division
Marketed Health Products Directorate
Tunney's Pasture, AL 0701C
Ottawa ON  K1A 0K9

NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.

More Information

This document plus the full product monograph, prepared for health professionals can be found at:
http://www.website.document
or by contacting the sponsor, <Sponsor Name>, at:
1-800-XXX-XXXX

This leaflet was prepared by <Sponsor Name>

Last revised: <MON DD, YYYY>.

Report a problem or mistake on this page
Please select all that apply:

Thank you for your help!

You will not receive a reply. For enquiries, contact us.

Date modified: