Metformin + Vildagliptin Tablets
Form: Tablets
Strength: 50/500 mg/850mg/1000mg
Reference Brands: Eucreas®(EU)
Category: Diabetes
EMA (EU): Approved as Eucreas® (Novartis) in fixed-dose combinations (50mg vildagliptin + 500/850/1000mg metformin). Key requirements: Boxed warnings: None, but pancreatitis risk requires discontinuation if suspected Hepatic monitoring: Mandatory (rare hepatitis reports) Renal restrictions: Contraindicated if eGFR <30; dose adjustment for eGFR 30-60 Storage: <30°C (protect from moisture) FDA (US): Not approved - Vildagliptin development discontinued in 2009 due to hepatotoxicity concerns in Phase III trials. Shared Requirements: Lactic acidosis warnings (metformin) Pregnancy Category B (avoid unless essential). For regulatory support: PharmaTradz.com
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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