Clinical Indication definition

Clinical Indication. For Children (aged 6 years and over) and Adolescents with Attention Deficit Hyperactivity Disorder (ADHD) The Shared Care Agreement (SCA) is intended to facilitate the accessibility and safe prescribing of complex treatments across the secondary/primary care interface. It does not contain all of the relevant product information, which should be sought using the current British National Formulary and Manufacturer’s Summary of Product Characteristics.
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Clinical Indication. For Children (aged 6 years and over) and Adolescents with Attention Deficit Hyperactivity Disorder (ADHD)
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Clinical Indication. Renal Anaemia
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Examples of Clinical Indication in a sentence

  • Where CMC Costs or Development Costs have not been incurred specifically in the development of the Licensed Product for a specific indication, such CMC Costs and Development Costs will be allocated to the account specified for the First Clinical Indication.

  • Any item number where the term “flag” is used in the Clinical Indication column highlights a potential exception that will require further justification.

  • To ensure its optimal execution nation-wide, CONAC opted for a two way approach:• a large dissemination of the methods of fighting corruption outlined in the document;• the follow-up of actions and results obtained.

  • Materials and Methods CT exams were classified into 5 different BMI categories based on Clinical Indication.

  • The Midwifery Council Number should be supplied in its full format e.g. 15-12345.Indication for Ultrasound ScanThe Clinical Indication Code that the Woman has been referred for.

  • Table 11: Clinical Indication for Transfusion (4325 patients) Indication for TransfusionNational(N=4325)Acute blood loss (R1) Transfusion Episode Number of units transfusedOne unit transfusions were given to 27% of inpatients and 13% of outpatients whereas 2 or 3 unit transfusions were given to 86% of day patients and 70% of inpatients.Fewer single unit transfusions were given to patients as part of a chronic transfusion programme (inpatients 24%, 22/91 and day patients 10%, 104/1014).

  • The updated Clinical Indication Codes came out last week, and are on JPAC.

  • A gene panel includes a Description box detailing the GMS Clinical Indication (where relevant) and linking to the eligibility statement for the 100,000 Genomes Project.

  • The Clinical Indication (e.g. R59 Early onset or syndromic epilepsy) is listed in the Description box, and the Clinical Indication code (R59) is listed in the ‘Relevant disorder’ field of a finalised GMS panel.

  • Systematic Review of the Risks of Carotid Endarterectomy in Relation to the Clinical Indication for and Timing of Surgery.


More Definitions of Clinical Indication

Clinical Indication means an area of treatment of a condition in the Disease Area. Examples of Clinical Indications are, without limitation: [***].
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Related to Clinical Indication

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

  • geographical indication , in relation to goods, means an indication which identifies such goods as agricultural goods, natural goods or manufactured goods as originating, or manufactured in the territory of a country, or a region or locality in that territory, where a given quality, reputation or other characteristic of such goods is essentially attributable to its geographical origin and in case where such goods are manufactured goods one of the activities of either the production or of processing or preparation of the goods concerned takes place in such territory, region or locality, as the case may be.

  • Collaboration Product means any pharmaceutical product in finished form that contains a Collaboration Compound, either as the sole active ingredient or in combination with one or more other active ingredients, and all present and future formulations, dosages and dosage forms thereof.

  • Diagnostic Product means an assemblage of reagents, including but not limited to reagents packaged in the form of a kit, useful in performing a Licensed Service.

  • Licensed Compound means a TAK-385 Licensed Compound or a TAK-448 Licensed Compound.

  • Licensed Product means any pharmaceutical product containing a Licensed Compound (alone or with other active ingredients), in all forms, presentations, formulations and dosage forms.

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

  • Licensed Compounds means: (a) Research Program Active Compounds; (b) Novartis Active Compounds; (c) salts, hydrates, solvates, esters, metabolites, intermediates, stereoisomers and polymorphs of Research Program Active Compounds or Novartis Active Compounds; and (d) prodrugs of Research Program Active Compounds or Novartis Active Compounds (any of the foregoing, a “Licensed Compound”).

  • Product Candidate means each biological and drug candidate, compound or other device or product being developed, labeled, manufactured, marketed, sold and/or distributed by the Company or a Company Subsidiary, or regarding which the Company or a Company has rights, and including any such biological and drug candidate, compound or product that has received Marketing Approval.

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

  • New Product means the Synology-branded hardware product and Synology-branded accessories contained in the original packaging Customer bought from an authorized Synology distributor or reseller. You may see our “New Product” at Product Support Status.

  • Clinical Study means a Xxxxx 0 Xxxxx, Xxxxx 2 Study, Phase 3 Study, Post-Marketing Study, Supplemental Study or other study (including a non-interventional study) in humans to obtain information regarding the product, including information relating to the safety, tolerability, pharmacological activity, pharmacokinetics, dose ranging or efficacy of the product.

  • Lead Compound means any compound of lead other than galena which, when treated in the manner described below, yields to an aqueous solution of hydrochloric acid a quantity soluble lead compound exceeding, when calculated as lead monoxide, five percent of the dry weight of the portion taken analysis.

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

  • Commercialization or “Commercialize” means any and all activities undertaken at any time for a particular Licensed Product and that relate to the manufacturing, marketing, promoting, distributing, importing or exporting for sale, offering for sale, and selling of the Licensed Product, and interacting with Regulatory Authorities regarding the foregoing.

  • Hemp product means the same as that term is defined in § 3.2-4112.

  • 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.

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • 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).

  • Collaboration Target means the Initial Collaboration Targets set forth on Exhibit F and any Additional Target or Substitute Target that is selected in accordance with Section 3.3 of this Agreement.

  • U.S. Territory means American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, the Commonwealth of Puerto Rico, or the U.S. Virgin Islands.

  • Development Candidate means a Compound that meets the Development Candidate Criteria for the initiation of a Development Program for the treatment of CF, and which is the subject of a notice from Vertex to CFFT that Vertex intends to commence formal pre-clinical development of the Compound in the Field pursuant to the provisions of Section 3.1 hereof.

  • Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.

  • 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.

  • 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.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.