VALSARTAN Film-coated tablet Ref.[7137] Active ingredients: Valsartan

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Product name and form

Valsartan 40mg Film-coated Tablets.

Valsartan 80mg Film-coated Tablets.

Valsartan 160mg Film-coated Tablets.

Valsartan 320mg Film-coated Tablets.

Pharmaceutical Form

Film-coated tablet.

Yellow, oval-shaped, biconvex, film-coated tablets (9.2 × 3.7 mm) debossed with ‘V’ and 1' on either side of the score line on one side and ‘M’ on the other side. The tablet can be divided into equal doses.

Pale red, round, biconvex, bevelled edge, film-coated tablets (8.2 mm) having a score line on one side and debossed with ‘M’ over ‘VN 2’ on other side. The tablet can be divided into equal doses.

Beige, oval-shaped, biconvex, bevelled edge, film-coated tablets (14.2 × 5.7 mm) debossed with ‘M’ to the left of the score on one side and ‘VN 3’ on the other side of the tablet. The tablet can be divided into equal doses.

Dark grey, oval-shaped, biconvex, film-coated tablets (17.7 × 8.2 mm) debossed with ‘VN 4’ on one side and ‘M’ on the other side.

Qualitative and quantitative composition

Each film-coated tablet contains 40 mg of valsartan.

Each film-coated tablet contains 80 mg of valsartan.

Each film-coated tablet contains 160 mg of valsartan.

Each film-coated tablet contains 320 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
Crospovidone
Povidone
Croscarmellose sodium
Silica, colloidal anhydrous
Magnesium stearate

Tablet coating:

Hypromellose E464
Titanium dioxide E171
Macrogol/PEG 8000
Iron oxide yellow E172
Iron oxide black E172 – [40, 160 and 320 mg tablets]
Iron oxide red E172 – [80, 160 and 320 mg tablets]

Pack sizes and marketing

Valsartan film-coated tablets are presented in the following pack types.

HDPE bottle pack (marketable pack) comprises of white HDPE bottle with white opaque polypropylene closure with induction sealing liner.

Cold form blister pack (marketable pack) comprises of cold form laminate (aluminium foil laminated to oriented polyamide on one side and to PVC on the other side i.e. OPA/Al/PVC) on one side and hard tempered aluminium foil coated with heat seal lacquer on the other side.

PVC/PE/PVDC-Aluminium triplex blister pack.

Valsartan is available in blister packs of 7, 10, 14, 28, 30, 56, 90, 98, 100 tablets, and HDPE bottles containing 28, 56, 98, 500, 1000 tablets. Not all pack sizes may be marketed. Valsartan 160 mg and 320 mg is also available in blister multipack containing 98 (2 packs of 49) tablets.

Marketing authorization holder

Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Marketing authorization dates and numbers

PL 04569/1175
PL 04569/1176
PL 04569/1177
PL 04569/1178

05/08/2011

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