New Indications definition

New Indications means an additional indication of the medicinal product which was approved by SIDC after the original registration of the medicinal product. O
New Indications means any indication for the Product other than the Initial Indications, which is subject to Takeda’s right of first refusal as provided in Section 3.2.
New Indications means any indication outside the Field (excluding Autoimmune Indications, Stem Cell Transplantation and Transplantation Indications).

Examples of New Indications in a sentence

  • New indications for treatment of chronic inflammation by TNF-alpha blockade.

  • New indications of classical formulations (Formulation existing in classics, but indication is changed with some clinical experience).

  • New indications may be added over time and others may also evolve.

  • Clinical changes for which new supporting data are provided from clinical trials, pre-clinical studies, post-marketing experience or publications, including:1.1 New indications in a therapeutic area for which the product was not previously indicated for use.1.2 New indications in respect of an organ, any other part of the human body, or infective organism for which the product was not previously indicated for use.

  • New indications arose and she was nowIreland and opened negotiations with James VI in Scotland, but these efforts failed.


More Definitions of New Indications

New Indications has the meaning set forth in Section 4.02(c).
New Indications means clinical indications, uses and applications for the Product other than what is included in the Field.
New Indications means any indication identified by KSB in which the Product may be used in addition to the Indications (including metastatic brain cancers ).
New Indications means, with respect to any Product, any Indication (other than the Initial Indications) approved by the JSC pursuant to Sections ‎3.1(a) and ‎3.4 in which such Product may be Developed, Manufactured and Commercialized under this Agreement.
New Indications means any indication of a disease state other than the Indications, that is developed as part of the Joint Development Program (excluding diagnosis).
New Indications means any indication for the Product other than the Initial Indications, which is subject to Takeda’s right of first refusal as provided in Section 3.2. “Party” or “Parties” shall have the meaning set forth in the introductory paragraph. “Phase IV Studies” shall mean clinical studies performed after obtaining Marketing Authorization for the purpose of supporting the marketing and Commercialization of the Product. For the avoidance of any doubt, “Phase IV Studies” does not include the RRS (as hereinafter defined). “Post-Marketing Surveillance” shall mean all post-marketing safety surveillance in the Initial Territory with respect to the Product that is required by a Regulatory Authority in the Initial Territory or any Additional Territory in which the Products are being Developed or Commercialized. “Primary Detail Equivalent” or “PDE” shall mean (a) one Primary Product Detail or (b) [**] Secondary Product Details.
New Indications means any topical indication for the Compound, Products or Subject Technology being proposed for addition to the Work Plan.