TROVAL Film-coated tablet Ref.[109437] Active ingredients: Valsartan

Source: Υπουργείο Υγείας (CY) Revision Year: 2021 Publisher: Delorbis Pharmaceuticals Ltd, 17 Athinon Street, Ergates Industrial Area, 2643 ergates, P.O. Box 28629, 2081 Lefkosia, Cyprus, European Union

Product name and form

Troval 40 mg Film-coated tablets.

Troval 80 mg Film-coated tablets.

Troval 160 mg Film-coated tablets.

Pharmaceutical Form
Film-coated tablet. 40 mg: Yellow, ovaloid, slightly convex film-coated tablets with bevelled edges, scored on one side. 80 mg: Slightly red, round, slightly convex film-coated tablets with bevelled edges, scored on one side. 160 mg: Grey-orange, ovaloid, slightly convex film-coated tablets with bevelled edges, scored on one side.

Qualitative and quantitative composition

One film-coated tablet contains 40 mg valsartan.

One film-coated tablet contains 80 mg valsartan.

One film-coated tablet contains 160 mg valsartan.

For a 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
Core tablet Microcrystalline cellulose silicified Starch pregelatinised Crospovidone Magnesium stearate Silica colloidal anhydrous Coating 40 mg: Opadry II yellow – 85G62626 (consisting of: polyvinyl alcohol – part. hydrolised, titanium dioxide (E171), talc (E553b), macrogol 3350, lecithin (soya) (E322), iron oxide yellow (E172), iron oxide red (E172), iron oxide black (E172), water purified). 80 mg: Opadry II pink – 85G64757 (consisting of: polyvinyl alcohol – part. hydrolised, titanium dioxide (E171), talc (E553b), macrogol 3350, lecithin (soya) (E322), iron oxide red (E172), iron oxide black (E172), iron oxide yellow (E172), water purified). 160 mg: Opadry II yellow – 85G62511 (consisting of: polyvinyl alcohol – part. hydrolised, titanium dioxide (E171), talc (E553b), macrogol 3350, iron oxide yellow (E172), lecithin (soya) (E322), iron oxide red (E172), iron oxide black (E172), water purified).

Pack sizes and marketing

For 40 mg strength: Blister packs, PVC/PE/PVdC/Aluminium or oPA/Aluminium/PVC-Aluminium of 10, 20, 28, 30, 50, 56, 60, 80, 90 tablets.

For 80 mg strength: Blister packs, PVC/PE/PVdC/Aluminium or oPA/Aluminium/PVC-Aluminium of 10, 20, 28, 30, 50, 56, 60, 80, 90 tablets.

For 160 mg strength: Blister packs, PVC/PE/PVdC/Aluminium or oPA/Aluminium/PVC-Aluminium of 10, 20, 28, 30, 50, 56, 60, 80, 90 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Delorbis Pharmaceuticals Ltd, 17 Athinon Street, Ergates Industrial Area, 2643 ergates, P.O. Box 28629, 2081 Lefkosia, Cyprus, European Union

Marketing authorization dates and numbers

40 mg: ML 22510
80 mg: ML 21333
160 mg: ML 21334

40 mg: 03/03/2017 / 09/06/2021

80 mg: 05/06/2012 / 10/10/2017

160 mg: 05/06/2012 / 10/10/2017

Drugs

Drug	Countries
TROVAL	Albania, Cyprus

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