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.
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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.
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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).
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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 inadequate seizure control despite treatment with at least ONE anti-epileptic drug Age RestrictionsN/A Prescriber RestrictionsNeurologist Coverage DurationPlan Year Other CriteriaN/ABENLYSTA DrugsBENLYSTACovered UsesAll FDA Approved Indications not otherwise excluded from Part D Exclusion CriteriaUse in severe active lupus nephritis or severe active CNS lupus Required Medical Information1.

  • Progression during or following at least one line of platinum-containing chemotherapy within 12 months Age Restrictions18 years of age or older Prescriber RestrictionsUrologist, nephrologist, or oncologist Coverage DurationPlan Year Other CriteriaN/ABANZEL DrugsRUFINAMIDECovered UsesAll FDA Approved Indications not otherwise excluded from Part D Exclusion CriteriaN/A Required Medical Information1.

  • Genuine liberalization began in July of 1990 when commercial banks were empowered by the Bank of Jamaica by means of delegated authority issued under the Exchange Control Act to open foreign exchange accounts.

  • 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.


More Definitions of Approved Indications

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.
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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
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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.
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Approved Indications means the Initial Indication plus any Additional Indication, individually and collectively as the case may be.
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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.
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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.
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Approved Indications means the treatment of paroxysmal supraventricular tachycardia (“PSVT”) in adults with a confirmed diagnosis of PSVT, which may include expected contraindications including but not limited to: hypersensitivity to Etripamil; heart failure - NYHA Class II to IV; known Wxxxx-Xxxxxxxxx-White (WPW), Lxxx-Xxxxxx-Xxxxxx (LGL) syndromes, sick sinus syndrome (except in patients with a functioning artificial ventricular pacemaker); second degree atrioventricular (AV) Mobitz 2 block and higher; or first degree AV block plus bundle branch block (BBB)/intraventricular conduction delay (IVCD), but shall exclude any and all Unexpected Contraindications.
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