Transcription of ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Galvus 50 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 mg of vildagliptin. Excipient with known effect: Each tablet contains mg lactose (anhydrous). For the full list of excipients, see section 3. PHARMACEUTICAL FORM Tablet. White to light yellowish, round (8 mm diameter), flat-faced, bevelled-edge tablet. One side is debossed with NVR , and the other side with FB . 4. CLINICAL PARTICULARS Therapeutic indications Vildagliptin is indicated in the treatment of type 2 diabetes mellitus in adults: As monotherapy - in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance.
2 1. NAME OF THE MEDICINAL PRODUCT Galvus 50 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 mg of vildagliptin.
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