Archived: Product Monograph Template - Notice of Compliance with Conditions
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[Title Page]
Product Monograph
Including Patient Medication Information
<Scheduling Symbol> <Brand Name>
<Proper name>
<Dosage Form(s), Strength(s) and Route(s) of Administration>
<Pharmaceutical Standard (if applicable)>
<Therapeutic Classification>
[For market authorizations without conditions]
"<Brand name> indicated for:
- < >
has been issued marketing authorization without conditions."
<Sponsor Name>
<Sponsor Address>
Date of Initial Approval:
<MON DD, YYYY>
Date of Revision:
<MON DD, YYYY>
Submission Control No: <control number>
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 authorized 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 will be identified in the left margin by the symbol NOC/c. These sections may include, but are not limited to, the following:
- Indications;
- Action and Clinical Pharmacology;
- 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 Canada Vigilance Program 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.
Recent Major Label Changes
<Section Heading>, <Subsection heading> <(Section or Subsection number)> <MON, YYYY>
<Section Heading>, <Subsection heading> <(Section or Subsection number)> <MON, YYYY>
Table of Contents
[To update, right-click anywhere in the Table of Contents and select "Update Field", "Update entire table", click OK.]
- Part I: Health Professional Information
- 1 Indications
- 2 Contraindications
- 3 Serious Warnings and Precautions Box
- 4 Dosage and Administration
- 5 Overdosage
- 6 Dosage Forms, Strengths, Composition and Packaging
- 7 Warnings and Precautions
- 8 Adverse Reactions
- 9 Drug Interactions
- 10 Action and Clinical Pharmacology
- 11 Storage, Stability and Disposal
- 12 Special Handling Instructions
- Part II: Scientific Information
- 13 Pharmaceutical Information
- 14 Clinical Trials
- 15 Microbiology
- 16 Non-clinical Toxicology
- 17 Supporting Product Monographs
- Patient Medication Information
[For market authorizations without conditions]
"<Brand name> indicated for:
- < >
has been issued marketing authorization without conditions."
Part I: Health Professional Information
1 Indications
<Brand name (proper name)> is indicated for:
- <text>
- <text>
[Include a brief discussion of any promising clinical information.]
<text>
1.1 Pediatrics
[One of the following or similar statements should be used:]
Pediatrics <(age range)> : Based on the data submitted and reviewed by Health Canada, the safety and efficacy of <Brand name> in pediatric patients has been established; therefore, Health Canada has authorized an indication for pediatric use. <(cross-reference to relevant sections)>
[or]
Pediatrics <(age range)> :No data are available to Health Canada; therefore,Health Canada has not authorized an indication for pediatric use.
[or]
Pediatrics <(age range)> : Based on the data submitted and reviewed by Health Canada, the safety and efficacy of <Brand name> in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use. <(cross-reference to relevant sections)>
1.2 Geriatrics
[One of the following or similar statements may be used:]
Geriatrics <(> x years of age )>: No data are available to Health Canada; therefore, Health Canada has not authorized an indication for geriatric use.
[or]
Geriatrics <(> x years of age)>: Evidence from clinical studies and experience suggests that use in the geriatric population is associated with differences in safety or effectiveness.
2 Contraindications
<Proper name> is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see Dosage Forms, Strengths, Composition and Packaging.
- <text>
- <text>
3 Serious Warnings and Precautions Box
[Delete this section if there is no Serious Warnings and Precautions box.]
- <text>
- <text>
4 Dosage and Administration
4.1 Dosing Considerations
[Briefly list all situations that may affect dosing of the drug:]
- <text>
- <text>
4.2 Recommended Dose and Dosage Adjustment
[Include dosages for each indication, route of administration and/or dosage form:]
<text>
[In the absence of a Health Canada authorized pediatric indication, the following or similar statement should be used:]
Health Canada has not authorized an indication for pediatric use. <(cross-reference to relevant sections, if applicable)>
4.3 Administration
<text and/or table>
4.4 Reconstitution
Oral Solutions: <text and/or table>
Parenteral Products: <table and text>
| Vial Size | Volume of Diluent to be Added to Vial | Approximate Available Volume | Nominal Concentration per mL |
|---|---|---|---|
| n/a | n/a | n/a | n/a |
[Include any specific precautions, storage periods and incompatibilities.]
4.5 Missed Dose
<text>
5 Overdosage
<text>
6 Dosage Forms, Strengths, Composition and Packaging
| Route of Administration | Dosage Form / Strength/Composition | Non-medicinal Ingredients |
|---|---|---|
| <oral> | <tablet 5 mg, 10 mg> | [List all non-medicinal ingredients in alphabetical order.] |
<text>
7 Warnings and Precautions
[If applicable, include the following statement:]
Please see the Serious Warnings and Precautions Box at the beginning of Part I: Health Professional Information.
[Subheadings to be included as applicable, in alphabetical order:]
General
<text>
Carcinogenesis and Mutagenesis
<text>
Cardiovascular
<text>
Dependence/Tolerance
<text>
Driving and Operating Machinery
[This subheading should include the following or similar statement:]
Due caution should be exercised when driving or operating a vehicle or potentially dangerous machinery.
Ear/Nose/Throat
<text>
Endocrine and Metabolism
<text>
Gastrointestinal
<text>
Genitourinary
<text>
Hematologic
<text>
Hepatic/Biliary/Pancreatic
<text>
Immune
<text>
Monitoring and Laboratory Tests
<text>
Neurologic
<text>
Ophthalmologic
<text>
Peri-Operative Considerations
<text>
Psychiatric
<text>
Renal
<text>
Respiratory
<text>
Sensitivity/Resistance
<text>
Sexual Health
Reproduction
<text>
Function
<text>
Fertility
<text>
Skin
<text>
7.1 Special Populations
7.1.1 Pregnant Women
<text>
[The extent of exposure in pregnancy during clinical trials should be included:
- Wide: > 1,000 pregnancies
- Limited: < 1,000 pregnancies
- Very Limited: individual cases only
- No experience]
7.1.2 Breast-feeding
<text>
[In the absence of human data, pertinent animal data should be included along with the following or similar statement:]
It is unknown if the drug is excreted in human milk. Because many drugs are excreted in human milk precaution should be exercised.
7.1.3 Pediatrics
[In the absence of a Health Canada authorized pediatric indication, one of the following or similar statements should be used:]
Pediatrics <(age range)> :No data are available to Health Canada; therefore,Health Canada has not authorized an indication for pediatric use.
[or]
Pediatrics <(age range)>: Based on the data submitted and reviewed by Health Canada, the safety and efficacy of <Brand name> in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use. <(cross-reference to relevant sections)>
<text>
7.1.4 Geriatrics
<text>
8 Adverse Reactions
8.1 Adverse Reaction Overview
<text>
8.2 Clinical Trial Adverse 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 reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates.
[Include a brief description of data sources.]
<text>
| n/a | <drug name> n = <#> (%) |
<placebo> n = <#> (%) |
|---|---|---|
| [use MedDRA terms for headings, as applicable] Cardiovascular <text> |
n/a | n/a |
[A brief narrative should follow the table to explain or supplement the information provided in the table:]
<text>
8.3 Less Common Clinical Trial Adverse Reactions
[Present as a list, categorized by System Organ Class, alphabetically:]
- Cardiovascular: <text>
- Gastrointestinal: <text>
8.4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data
<table>
8.5 Clinical Trial Adverse Reactions (Pediatrics)
<text>
8.6 Post-Market Adverse Reactions
<text and/or table>
9 Drug Interactions
9.1 Serious Drug Interactions Box
[Delete this section if there is no Serious Drug Interactions box.]
[Serious (e.g., life-threatening) drug interactions should be highlighted in this box. Not to exceed 20 lines.]
- <text>
- <text>
9.2 Overview
<text>
9.3 Drug-Drug Interactions
The drugs listed in this table are based on either drug interaction case reports or studies, or potential interactions due to the expected magnitude and seriousness of the interaction (i.e., those identified as contraindicated).
[or]
Interactions with other drugs have not been established.
9.4 Drug-Food Interactions
| <Proper /Common name> | Source of Evidence | Effect | Clinical comment |
|---|---|---|---|
| <drug A> | <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 | |||
<text>
9.5 Drug-Herb Interactions
<text>
9.6 Drug-Laboratory Test Interactions
<text>
9.7 Drug-Lifestyle Interactions
<text>
10 Action and Clinical Pharmacology
10.1 Mechanism of Action
<text>
10.2 Pharmacodynamics
<text>
10.3 Pharmacokinetics
Table <#> - Summary of <proper name> Pharmacokinetic Parameters in <specific patient population>
| n/a | Cmax | Tmax | t½ (h) | AUC0-∞ | CL | Vd |
|---|---|---|---|---|---|---|
| Single dose mean | n/a | n/a | n/a | n/a | n/a | n/a |
Absorption: <text>
Distribution: <text>
Metabolism: <text>
Elimination : <text>
Special Populations and Conditions
Pediatrics: <text>
Geriatrics: <text>
Sex : <text>
Pregnancy and Breast-feeding: <text>
Genetic Polymorphism: <text>
Ethnic origin: <text>
Hepatic Insufficiency: <text>
Renal Insufficiency: <text>
Obesity: <text>
11 Storage , Stability and Disposal
<text>
12 Special Handling Instructions
<text>
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."
13 Pharmaceutical Information
Drug Substance
Proper name: <text>
Chemical name: <text>
Molecular formula and molecular mass: <text>
Structural formula: <image>
Physicochemical properties: <text>
14 Clinical Trials
14.1 Trial Design and Study Demographics
| Study # | Trial design | Dosage, route of administration and duration | Study subjects (n) | Mean age (Range) | Sex |
|---|---|---|---|---|---|
| n/a | n/a | n/a | n/a | n/a | n/a |
[Provide a brief narrative describing the demographic characteristics of the study population:]
<text>
14.2 Study Results
| Primary Endpoints | Associated value and statistical significance for Drug at specific dosages | Associated value and statistical significance for Placebo or active control |
|---|---|---|
| n/a | n/a | n/a |
[Include Comparative Bioavailability Studies (if required). See format in Standard Template.]
15 Microbiology
<text>
<table>
16 Non-clinical Toxicology
[Narrative where possible. Include a table only where presentation is made more concise.]
<text>
17 Supporting Product Monographs
[Where there are no supporting product monographs, this section should be omitted.]
[numbered list:]
<Brand name> <(dosage form, strength)>, submission control <number>, Product Monograph, <sponsor>. <(MON, DD, YYYY)>
Read This for Safe and Effective Use of Your Medicine
Patient Medication Information
<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>.
What is <Brand name> used for?
[Briefly summarize the indication(s) and refer to the reader to the NOC/c summary box below for additional detail.]
[Provide a bullet listing of the indications from Part I.]
- <text>
[If the Indications section includes lifestyle recommendations as part of the therapy, they should be included here.]
"For the following indication(s) <Brand name> has been approved without conditions. This means it has passed Health Canada's review and can be bought and sold in Canada."
[Provide a bullet listing of the indications from Part I.]
- <text>
What is a Notice of Compliance with Conditions (NOC/c)?
A Notice of Compliance with Conditions (NOC/c) is a type of approval to sell a drug 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.
- < text>
- < text>
How does <Brand name> work?
[At the grade 6-8 reading level, explain the mechanism of action, in one or two sentences. Indicate how long it takes to work and how to know if it is working.]
<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:
[To maintain brevity, this is the only information required in this section.]
< 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>
[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.
< 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.]
| 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> |
n/a | n/a | n/a |
| < Condition: symptom / effect> | n/a | n/a | n/a |
| Common < Condition: symptom / effect> |
n/a | n/a | n/a |
| < Condition: symptom / effect> | n/a | n/a | n/a |
| Rare < Condition: symptom / effect> |
|||
| < Condition: symptom / effect> | n/a | n/a | n/a |
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.
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
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 Patient 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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