CODAVAL Film-coated tablet Ref.[109438] Active ingredients: Valsartan

Source: Υπουργείο Υγείας (CY)  Revision Year: 2019  Publisher: Codal-Synto Ltd, 21 Konstantinoupoleos Street, 3011 Limassol, Cyprus

Product name and form

Codaval 40 mg film-coated tablets.

Codaval 80 mg film-coated tablets.

Codaval 160 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

40 mg film-coated tablets: Yellow, round, convex, film-coated tablets with diameter of nucleus 8mm

80 mg film-coated tablets: Yellow, round, convex, scored, film-coated tablets with diameter of nucleus 10.4mm. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

160 mg film-coated tablets: Yellow, convex, scored on one side, embossed “MC” on the other side, cap-tab, film-coated tablets with dimensions of nucleus 17.5 × 8mm. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Qualitative and quantitative composition

Codaval 40 mg film-coated tablets: One film-coated tablet contains 40 mg of valsartan.

Codaval 80 mg film-coated tablets: One film-coated tablet contains 80 mg of valsartan.

Codaval 160 mg film-coated tablets: One film-coated tablet contains 160 mg of valsartan.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Valsartan

Valsartan is an orally active, potent, and specific angiotensin II (Ang II) receptor antagonist. It acts selectively on the AT1-receptor subtype, which is responsible for the known actions of angiotensin II.

List of Excipients

Tablet core:

Microcrystalline cellulose 101
Crospovidone type A
Povidone K30
Colloidal anhydrous silica
Magnesium stearate

Film coat:

Polyvinyl alcohol-partially hydrolyzed
Titanium dioxide E171
Macrogol/PEG 3350
Talc
Quinoline yellow aluminium lake (E104)

Pack sizes and marketing

PVC/PE/PVDC-Alu blisters.

PVC/PCTFE-Alu blisters.

Pack sizes: 7, 14, 28, 30, 56, 60, 90, 98, 100, 280 film- coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Codal-Synto Ltd, 21 Konstantinoupoleos Street, 3011 Limassol, Cyprus

Marketing authorization dates and numbers

Codaval 40 mg film coated tablets: M.L.No. 21930

Codaval 80 mg film coated tablets: M.L.No. 21931

Codaval 160 mg film coated tablets: M.L.No. 21932

July 2013 / 18/07/2019

Drugs

Drug Countries
CODAVAL Albania, Cyprus

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