Medicinal Product Sample Clauses
The 'Medicinal Product' clause defines what constitutes a medicinal product within the context of the agreement. It typically specifies the particular drug, compound, or therapy covered, including its formulation, dosage, and intended use. This clause ensures that all parties have a clear and shared understanding of the exact product being referenced, thereby preventing ambiguity and potential disputes over the scope of the agreement.
Medicinal Product. Any and all pharmaceutical preparations in final form containing the Compound or a Backup Compound whether or not as the sole therapeutically active ingredient or in combination or adjunctive therapy with any other active or inactive ingredient, in any dosage form or formulation or method of delivery. To avoid doubt, the term “Medicinal Product” will, where the context admits and requires, include “Investigational Medicinal Products”.
Medicinal Product. Any medicine prepared in advance, marketed under a specific denomination and with a particular packaging.
Medicinal Product. Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis. Use of a medicinal product in a way, which has not been specified by the Company in the product label or as prescribed by the physician. Periodic safety update reports mean the periodical reports containing the records referred to in Article 104 of Directive 2001/83/EC and in Article 24(3) of Regulation (EC) No 726/2004. A PSUR is intended to provide an update of the worldwide safety experience of a Medicinal Product to Competent Authorities at defined time points post-authorisation. At these times the Marketing Authorisation Holders are expected to provide succinct summary information together with a critical evaluation of the risk-benefit balance of the product in light of new or changing information. This evaluation should ascertain whether further investigations need to be carried out and whether changes should be made to the market authorisation and product information. CMS is responsible for translating, submitting documents and providing documentation of the success of the submission.
Medicinal Product. Those medicinal products listed below with their respective generic names or compound numbers: Zovirax® Ointment or Zovirax® Cream; each in the presentations and formulations in finished product form, as described below, or as developed by GSK under the terms of the Agreement. Zovirax Ointment 3G 0173099341 1 tube Zovirax Ointment 15G 0173099394 1 tube Zovirax Cream 2G TBA* 1 tube * To be assigned upon approval of the Zovirax Cream NDA