Appendix F Template - NOC/c Product Monograph

[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>

Submission Control No: <control number> [optional]

This product has been approved under the Notice of Compliance with Conditions (NOC/c) 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 trials to verify its clinical benefit. Patients should be advised of the nature of the authorization. For further information for <Brand name> please refer to Health Canada's Notice of Compliance with conditions - drug products web site:"

[For market authorizations without conditions]
"<Brand name> indicated for:
- < >
has been issued marketing authorization without conditions."

Summary Product Information
Route of Administration Dosage 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.

NOC/c 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]

[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>

NOC/c 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>

NOC/c 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>

NOC/c 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>

Serious Drug Interactions

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

  • <text>
  • <text>

Drug Interactions

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> Ref Effect Clinical comment

<drug name>

<level of evidence, see legend>

<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>

NOC/c 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:
Reconstitution
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>

For management of a suspected drug overdose, contact your regional Poison Control Centre.

NOC/c 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-∞ 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 Forms, Composition and Packaging

<Narrative>

Part II: Scientific Information

"<Brand name>, indicated for:
- < >
has been issued marketing authorization with conditions, pending the results of trials to verify its clinical benefit. Patients should be advised of the nature of the authorization. For further information for <Brand name> please refer to Health Canada's Notice of Compliance with conditions - drug products web site:"

[For market authorizations without conditions]
"<Brand name> indicated for:
- < >
has been issued marketing authorization without conditions."

Pharmaceutical Information

Drug Substance

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

NOC/c 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

[Table Format Wherever Possible]

References

[numbered list]

Read this for safe and effective use of your medicine

Patient Medication Information

A Notice of Compliance with Conditions (NOC/c) is a type of approval to sell a drug in Canada.

"<Brand name> is used in/as:

- < >

It has been approved with conditions. This means it has passed Health Canada's review and can be bought and sold in Canada, but the manufacturer has agreed to complete more studies to make sure the drug works the way it should. For more information, talk to your healthcare professional."

"<Brand name> is used in/as:

- < >

It has been approved without conditions. This means it has passed Health Canada's review and can be bought and sold in Canada."

Health Canada only gives an NOC/c to a drug that treats, prevents, or helps identify a serious or life-threatening illness. The drug must show promising proof that it works well, is of high quality, and is reasonably safe. Also, the drug must either respond to a serious medical need in Canada, or be much safer than existing treatments.

Drug makers must agree in writing to clearly state on the label that the drug was given an NOC/c, to complete more testing to make sure the drug works the way it should, to actively monitor the drug's performance after it has been sold, and to report their findings to Health Canada.

<Brand Name>
<Proper Name in final dosage form>

Read this carefully before you start taking <Brand name> and each time you get a refill. This leaflet is a summary and will not tell you everything about this drug. Talk to your healthcare professional about your medical condition and treatment and ask if there is any new information about <Brand name>.

Serious Warnings and Precautions

  • <text>
  • <text>

What is <Brand name> used for?

  • <text>
  • <text>

How does <Brand name> work?
<text>

What are the ingredients in <Brand name>?
Medicinal ingredients: [List all medicinal ingredients from Part I.]
Non-medicinal ingredients: [List all non-medicinal ingredients in alphabetical order from Part I.]

<Brand name> comes in the following dosage forms:
<dosage form(s) and strength(s)>

Do not use <Brand name> if:
[Enter one point for each contraindication from Part I.]

  • <text>
  • <text>

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take <Brand name>. Talk about any health conditions or problems you may have, including if you:

[Enter one point for each warning and precaution from Part I.]

  • <text>
  • <text>

Other warnings you should know about:
[Enter general information that would not appear in the serious warnings and precautions box or other existing headings. Otherwise this heading is not required.]
<text>

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with <Brand name>:

  • <list>

How to take <Brand name>:
<text>

Usual dose:
<text>

Overdose:
<text>

If you think you have taken too much <Brand name>, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

[The boxed message may be modified to provide the most appropriate advice according to current standards of care for this drug product.]

Missed Dose:

<text>

What are possible side effects from using <Brand name>?

These are not all the possible side effects you may feel when taking <Brand name>. If you experience any side effects not listed here, contact your healthcare professional. Please also see Warnings and Precautions.

<text>

[Self-limiting side effects should be described in the text section only. Serious side effects must be listed in the serious side effects table. Each side effect should appear only once, in text or in the table, as duplication generally is not wanted in Part III.]

Serious side effects and what to do about them
Symptom / effect Talk to your healthcare professional Stop taking drug and get immediate medical help
Only if severe In all cases

Very common
< Condition: symptom / effect>

< Condition: symptom / effect>

Common
< Condition: symptom / effect>

< Condition: symptom / effect>

Rare
< Condition: symptom / effect>

< Condition: symptom / effect>

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.

3 ways to report:

  • Online at MedEffect;
  • By calling 1-866-234-2345 (toll-free);
  • By completing a Consumer Side Effect Reporting Form and sending it by:
    • Fax to 1-866-678-6789 (toll-free), or
    • Mail to: Canada Vigilance Program
      Health Canada, Postal Locator 0701E
      Ottawa, ON
      K1A 0K9

Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:
<text>

Keep out of reach and sight of children.

If you want more information about <Brand name>:

  • Talk to your healthcare professional
  • Find the full product monograph that is prepared for healthcare professionals and includes this consumer medication information by visiting the Health Canada website; the manufacturer's website <website>, or by calling 1-800-<phone number>.

This leaflet was prepared by <Sponsor Name>

Last Revised <MON-DD-YYYY>

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