Labeled Indication definition

Labeled Indication means any Indication of a Product as set forth in the Product’s label as approved by the relevant Regulatory Authority. “Initial Labeled Indication” means any Labeled Indication upon a Product’s initial receipt of Regulatory Approval (regardless of the number of Indications described). “Additional Labeled Indication” means any Labeled Indication added to a Product’s label after the Initial Labeled Indication or expanding the scope of a previous Labeled Indication, which is approved by way of a supplemental Regulatory Approval (e.g., by way of sNDA or sBLA) [***].
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Examples of Labeled Indication in a sentence

  • Have utilized Geistlich biomaterials in accordance with a Labeled Indication, including use of the biomaterials with techniques appropriate for such biomaterials.

  • For the avoidance of doubt, JSC involvement in the preparation and submission of the MAA seeking Final Marketing Authorization, including whether to pursue the Narrow Labeled Indication or the Broad Labeled Indication, and any decisions made under this Section 3 in connection therewith shall be without prejudice to Daiichi Sankyo’s rights under Sections 7.2(b) or 16.2(c).

  • Regulatory Approval in the EU of the Product for an Additional Labeled Indication (†††) [***] [***] [***] [***] (††) For the avoidance of doubt, the total amount payable under Milestones 5 and 6 shall not exceed [***] for each Product per Target.

  • For the avoidance of doubt, JSC involvement in the preparation and submission of the MAA seeking Final Marketing Authorization, including whether to pursue the Narrow Labeled Indication or the Broad Labeled Indication, and any decisions made under this S ection 3 in connection therewith shall be without prejudice to Daiichi Sankyo’s rights under S ections 7.2(b) or 1 6.2(c).

  • This information will only be used internally within Freedom Community Alliance (FCA) whilst the applicant remains a client or resident unless the applicant has given specific written consent for it to be shared with another individual or organization.However, if FCA considers there is serious risk of harm to others or the applicant/resident, section 115 of the Crime and Disorder Act 1998 provides that the information may be shared as necessary to prevent such harm.

  • In their determination of the number of patients in each such population, the Parties shall make each determination as of the date set forth in the definition of the population (i.e., the Actual Labeled Indication Population shall each be determined [***], and the Narrow Labeled Indication Population shall be determined [***].

Related to Labeled Indication

  • First Indication means the first disease condition for which a particular Licensed Product has been approved by a Regulatory Authority.

  • Initial Indication means the use of a Product for the treatment of opioid addiction.

  • Therapeutic Product means a health product categorised as a therapeutic product in the First Schedule to the Act;

  • Diagnostic Product means any test or assay for diagnosing or detecting a disease, disorder, medical condition, or symptom.

  • Phase I Trial means a Clinical Trial, the principal purpose of which is preliminary determination of safety of an investigational product in healthy individuals or patients or that otherwise meets the requirements described in 21 C.F.R. §312.21(a), or similar Clinical Trial in a country other than the United States.

  • Second Indication means [***].

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Additional Indication means any indication other than the Initial Indication.

  • Clinical Trial means any human clinical trial of a Product.

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Biological Samples means any physical samples obtained from Study Participants in accordance with the Protocol for the purposes of the Study.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • cosmetic product means any substance or mixture intended to be placed in contact with the external parts of the human body (epi­ dermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours;

  • Phase 2 Clinical Trial means a human clinical trial, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory other than the United States.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Nicotine product means a product that contains nicotine and is not any of the following:

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • Massive Multiauthor Collaboration Site (or “MMC Site”) means any World Wide Web server that publishes copyrightable works and also provides prominent facilities for anybody to edit those works. A public wiki that anybody can edit is an example of such a server. A “Massive Multiauthor Collaboration” (or “MMC”) contained in the site means any set of copyrightable works thus published on the MMC site.

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • complex product means a product which is composed of multiple components which can be replaced permitting disassembly and re-assembly of the product.