Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
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. |
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 Tablet coating: Hypromellose E464 |
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.
Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
PL 04569/1175
PL 04569/1176
PL 04569/1177
PL 04569/1178
05/08/2011
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
