Product Monograph definition

Product Monograph means a factual, scientific document on the Product approved by Health Canada that, devoid of promotional material, describes the properties, claims, indications and conditions of use of the drug and contains any other information that may be required for optimal, safe and effective use of the drug.
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Product Monograph means a written description of particular elements on an identified topic which presents information supporting the safety, efficacy or quality of a medicinal ingredient or a NHP that NNHPD has reviewed and determined to be acceptable;
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Examples of Product Monograph in a sentence

  • Moreover, the inducement of the act of direct infringement by the Product Monograph will clearly be with Apotex’s knowledge, thus satisfying the third and last prong of the test for inducing infringement.

  • A complete listing of possible serious conditions that may develop during treatment with ribavirin is presented in Appendix A (PEGETRON® Product Monograph).

  • It is not in dispute that the Product Monograph states that “APO-ABIRATERONE (abiraterone acetate) is indicated in combination with prednisone for the treatment of metastatic prostate cancer (castration- resistant prostate cancer, mCRPC) in patients […]” This contemplates all of the essential elements of the patented combination.

  • It argues that infringement requires that both components of the claimed combination contribute meaningful anti-cancer effects, but the Product Monograph contemplates PN only for its palliative effects.

  • As often is the case in matters decided pursuant to the Regulations, the question of whether Apotex will induce infringement turns mainly on the content of the proposed product monograph for APO-ABIRATERONE (the Product Monograph) because this document indicates how Apotex proposes to market the drug.

  • Third, the influence must knowingly be exercised by the inducer, that is, the inducer knows that this influence will result in the completion of the act of infringement … [54] The first prong (an act of direct infringement) will be satisfied when someone combines APO-ABIRATERONE with PN as proposed in the Product Monograph at the time of administration.

  • The key to the second prong of the test is the act that the Product Monograph induces.

  • Before the Investigation begins, and from time to time throughout the course of the Investigation, as determined by ACS, ACS shall provide CroMedica and all Investigators with a current Investigator Brochure and Product Monograph for the study compound.

  • The fact that an anti-cancer effect of PN may be incidental to its palliative effects does not alter the fact that direct infringement will inevitably result from the use of the combination as contemplated in the Product Monograph.

  • Apotex argues that the Federal Court erred when it concluded that the Product Monograph was sufficient to satisfy the second prong of the test (influence to the point that, without it, direct infringement would not take place).