Therapeutic Indication definition

Therapeutic Indication means treatment of all cancers within the field of Oncology.
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Therapeutic Indication means (i) treatment of any disease for GX-H9, (ii) treatment of any disease for GX-G6, (iii) treatment of any disease for GX-G3, (iv) with respect to GX- G8, treatment of chemically induced diarrhea (CID), and (v) with respect to GX-P2, treatment of rheumatoid arthritis (RA) and lupus (not including psoriasis).
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Therapeutic Indication means the treatment, prevention or palliation of any disease or non-aesthetic medical condition, including but not limited to, cervical dystonia, plantar fasciitis, chronic migraine, upper and lower limb spasticity, hyperhidrosis, urinary incontinence, overactive bladder, strabismus, facial spasm, blepharospasm, and focal dystonia.
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Examples of Therapeutic Indication in a sentence

  • Other than what is necessary to enable I-Mab to perform pre-clinical/clinical development, manufacturing, sale and distribution of the Licensed Product for the Therapeutic Indication within the Territory, I-Mab shall not perform such licensed activities outside of the Territory without Genexine’s prior written consent.

  • For clarity, Genexine has the right to license the Platform Patents to a third party in the Territory, provided, however, that, I-Mab shall be the sole and exclusive licensee in the Territory to use and otherwise exploit the Licensed Intellectual Properties to engage in pre-clinical/clinical development, manufacturing, sale and distribution of the Licensed Product for the Therapeutic Indication.

  • For clarity, Genexine has the right to license the Licensed Intellectual Properties to a third party in the Territory, provided, however, that Tasgen shall be the sole and exclusive licensee in the Territory to use and otherwise exploit the Licensed Intellectual Properties to engage in pre-clinical/clinical development, manufacturing, sale and distribution of the Licensed Products for the Therapeutic Indication.

  • NoYesEmployment with company/institution If ‘YES’, please provide details below: Company/ InstitutionRole/FunctionProduct, Therapeutic Indication, ManufacturerTime Period MM/YYYY – MM/YYYY <Please add more rows if needed> 2.2 Consultancy <’Consultancy’ means provision of advice (including training on a one-to-one basis, preparation of HTA reports or HTA submission) to a company/institution (as defined in 2.1), regardless of contractual arrangements or any form of remuneration.

  • When new customers are added, both Parties will agree whether sales to the customer are for the Cosmetic or Therapeutic Indication or on the ratio to be used to allocate the sales to the Cosmetic or Therapeutic Indication.

  • After a process that lasted more than 90 years, Peru’s "National Technical Guide on the Standardization of the Comprehensive Care of the Pregnant Woman in the Voluntary Termination of Pregnancy of less than 22 weeks by Therapeutic Indication with Informed Consent in the framework of Article 119° of the Criminal Code" was published on June 28, 2014.

  • Proposed Therapeutic Indication and Dosage RegimenNamenda XR is indicated for the treatment of moderate to severe dementia of Alzheimer’s type.

  • Approval of BLA by NMPA for 3rd Therapeutic Indication $[*] * If the Therapeutic Indication approved by the FDA in Milestone Nos.

  • Maintain required regulatory training1.1 Ensure up-to-date training, for example:• Good Clinical Practices (GCP)• Safety training, as required• Good Pharmacoepidemiological Practices (GPP), as required• Therapeutic Indication, as needed• Company Standard Operating Procedures (SOPs)• Electronic Data Capture (EDC) 2.

  • Clinical Particulars 4.1 Therapeutic Indication For the treatment of patients with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis.


More Definitions of Therapeutic Indication

Therapeutic Indication means, with respect to any SELECTIVE ALPHA-1a ADRENERGIC RECEPTOR PRODUCT, the main therapeutic use as classified in the 2nd level of the World Health Organization Anatomical, Therapeutic, Clinical (ATC) drug classification system.
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Therapeutic Indication means the specific use of a Licensed Product or Licensed Service for the prevention or treatment of a Specific Clinical Condition that requires obtaining a separate approval by the Food and Drug Administration (FDA) for promoting the Sale of the Licensed Product or Licensed Service to treat that Specific Clinical Condition.
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Related to Therapeutic Indication

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

  • Therapeutic diet means meals served that are soft, low-fat, low-sodium or controlled calorie.

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

  • Therapeutic school means a residential group living facility:

  • 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;

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

  • Therapeutically equivalent drug products means drug products that contain the same active ingredients and are identical in strength or concentration, dosage form, and route of administration and that are classified as being therapeutically equivalent by the U.S. Food and Drug Administration pursuant to the definition of "therapeutically equivalent drug products" set forth in the most recent edition of the Approved Drug Products with Therapeutic Equivalence Evaluations, otherwise known as the "Orange Book."

  • Licensed Product means a product or part of a product in the Licensed Field of Use: (A) the making, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent; or (B) which is made with, uses or incorporates any Technology.

  • Therapeutic equivalent means that a Covered Drug can be expected to produce essentially the same therapeutic outcome and toxicity.

  • 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.

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

  • 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.

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

  • 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;

  • Licensed Compound means [***].

  • Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings.

  • Product Candidate means any pharmaceutical product developed, manufactured and/or tested by or on behalf of the Company that has not received a Regulatory Authorization for commercial distribution other than in connection with pre-clinical or clinical trials.

  • Therapeutic interchange means an authorized exchange of therapeutic alternate drug products in accordance with a previously established and approved written protocol.

  • Medical marijuana product means a product that contains cannabinoids that have been extracted from plant material or the resin therefrom by physical or chemical means and is intended for administration to a licensed patient, including but not limited to concentrates, oils, tinctures, edibles, pills, topical forms, gels, creams, and other derivative forms, except that this term does not include live plant forms.

  • Biosimilar Product means, with respect to a Licensed Product and on a country-by-country basis, a product that [***].

  • 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.

  • Active Pharmaceutical Ingredient or “API” shall mean one or more of the following active pharmaceutical ingredients: tenofovir alafenamide (“TAF”), tenofovir disoproxil fumarate (“TDF”), elvitegravir (“EVG”), and cobicistat (“COBI”).

  • Marijuana product means marijuana as defined in 50-32-101 and marijuana-infused products

  • 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”).

  • Therapeutic care means services provided by licensed or certified speech pathologists, Occupational Therapists and Physical Therapists.

  • 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.