Approved Indications definition

Approved Indications means any indications in any jurisdiction in the Field for which CPP has made a submission seeking Regulatory Approval for the Products.

Approved Indications means the precise and written descriptions for use as defined by the Registrations, the Market Authorizations and as may otherwise be defined by the Registration Authorities in the Countries within the Territory. Approved Indication(s) shall be specified in Exhibits to this Agreement, as samples of approved Product labeling, translated into English for convenience.

Approved Indications shall be those indications that are approved by the Swedish regulatory authorities as of the Effective Date of this Agreement, and those that may be approved through the Mutual Recognition Process in other countries within the EU, upon the initial application for approval.

Examples of Approved Indications in a sentence

• Requires more than 200 units of insulin per day Age RestrictionsN/A Prescriber RestrictionsN/A Coverage DurationPlan Year Other CriteriaN/AIBRANCE DrugsIBRANCECovered UsesAll FDA Approved Indications not otherwise excluded from Part D Exclusion CriteriaN/A Required Medical Information1.

• Pt has recurring lesions after surgical excision OR surgery is contraindicated or inappropriate Age RestrictionsN/A Prescriber RestrictionsDermatologist or Oncologist Coverage DurationPlan Year Other CriteriaN/AERLEADA DrugsERLEADACovered UsesAll FDA Approved Indications not otherwise excluded from Part D Exclusion CriteriaN/A Required Medical InformationMust meet at least ONE of the following:1.

• An adult pt has undergone colonoscopy of the entire colon within the past 6 months or a pediatric pt has undergone a colonoscopy of the entire colon in the past 6 months if there has been unexplained blood in the stool Age RestrictionsN/A Prescriber RestrictionsGastroenterologist Coverage Duration Initial: 6 months, Reauth: Plan Year Other CriteriaN/AGAVRETO DrugsGAVRETOCovered UsesAll FDA Approved Indications not otherwise excluded from Part D Exclusion CriteriaN/A Required Medical Information1.

• Previous use of two of topiramate, valproic acid, or clobazam Age Restrictions2 years of age or older Prescriber RestrictionsNeurologist or epileptologist Coverage DurationPlan Year Other CriteriaN/AFIRAZYR DrugsICATIBANT ACETATECovered UsesAll FDA Approved Indications not otherwise excluded from Part D Exclusion CriteriaN/A Required Medical Information1.

• If request not for generic tobramycin: Previous trial on generic tobramycin Age RestrictionsN/A Prescriber RestrictionsPulmonologist or Infectious Disease Specialist Coverage DurationPlan Year Other CriteriaBvsD determinationDAURISMO DrugsDAURISMOCovered UsesAll FDA Approved Indications not otherwise excluded from Part D Exclusion CriteriaN/A Required Medical Information1.

More Definitions of Approved Indications

Approved Indications means the following clinical indications for Licensed Products: (a) short-term treatment of duodenal ulcer (4-8 weeks), (b) short-term treatment of active benign gastric ulcer (4-8 weeks), (c) treatment of heartburn and other symptoms associated with gastroesophageal reflux disorder, or GERD, (d) short-term treatment of erosive esophagitis diagnosed by endoscopy (4-8 weeks), (e) maintenance of healing of erosive esophagitis and (f) reduction of risk of upper gastrointestinal bleeding in critically ill patients.

Approved Indications means the Primary Indication and the Other Indications, in each case at such time as Regulatory Approval for such indication has been obtained.

Approved Indications means the Initial Indication plus any Additional Indication, individually and collectively as the case may be.

Approved Indications means the precise and written descriptions for use as defined by the Registrations, the Market Authorizations and as may otherwise be defined by the Registration Authorities in the Countries within the Viragen International, Inc. & Orphan Australia Pty. Ltd. License Agreement 1

Approved Indications means those indications for which Final Product has received Approval in Japan.

Approved Indications means, with respect to a Product, the indications for which such Product has been approved for marketing in the Territory as of the Closing Date by the applicable Healthcare Regulatory Authority as set forth in the Health Registration for such Product as of the Closing Date.

Approved Indications means any Indication for which a Product has received Regulatory Approval (whether in the United States or in any other country in the Territory).