VERQUVO Film-coated tablet Ref.[27620] Active ingredients: Vericiguat

Source: European Medicines Agency (EU)  Revision Year: 2021  Publisher: Bayer AG, 51368 Leverkusen, Germany

Product name and form

Verquvo 2.5 mg film-coated tablets.
Verquvo 5 mg film-coated tablets.
Verquvo 10 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (tablet).

Verquvo 2.5 mg film-coated tablets: Round, biconvex, white film-coated tablet with a diameter of 7 mm, marked with “2.5” on one side and “VC” on the other side.

Verquvo 5 mg film-coated tablets: Round, biconvex, brown-red film-coated tablet with a diameter of 7 mm, marked with “5” on one side and “VC” on the other side.

Verquvo 10 mg film-coated tablets: Round, biconvex, yellow-orange film-coated tablet with a diameter of 9 mm, marked with “10” on one side and “VC” on the other side.

Qualitative and quantitative composition

Verquvo 2.5 mg film-coated tablets

Each film-coated tablet contains 2.5 mg vericiguat.

Excipient with known effect: Each film-coated tablet contains 58.14 mg lactose (as monohydrate), see section 4.4.

Verquvo 5 mg film-coated tablets

Each film-coated tablet contains 5 mg vericiguat.

Excipient with known effect: Each film-coated tablet contains 55.59 mg lactose (as monohydrate), see section 4.4.

Verquvo 10 mg film-coated tablets

Each film-coated tablet contains 10 mg vericiguat.

Excipient with known effect: Each film-coated tablet contains 111.15 mg lactose (as monohydrate), see section 4.4.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Vericiguat

Vericiguat is a stimulator of soluble guanylate cyclase (sGC). Heart failure is associated with impaired synthesis of nitric oxide (NO) and decreased activity of its receptor, sGC. The pharmacodynamic effects of vericiguat are consistent with the mode of action of a sGC stimulator resulting in smooth muscle relaxation and vasodilation.

List of Excipients

Tablet core:

Microcrystalline cellulose
Croscarmellose sodium
Hypromellose 2910
Lactose monohydrate
Magnesium stearate
Sodium laurilsulfate

Film-coat:

Hypromellose 2910
Talc
Titanium dioxide (E171)
Iron oxide red (E172) (Verquvo 5 mg only)
Iron oxide yellow (E172) (Verquvo 10 mg only)

Pack sizes and marketing

PVC/PVDC/Aluminium foil blisters in cartons of 14, 28 or 98 film-coated tablets or perforated unit dose blisters in cartons of 10 × 1 or 100 × 1 film-coated tablets.

PP/Aluminium foil blisters in cartons of 14, 28 or 98 film-coated tablets or perforated unit dose blisters in cartons of 10 × 1 or 100 × 1 film-coated tablets.

HDPE bottles with a PP screw cap containing 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Bayer AG, 51368 Leverkusen, Germany

Marketing authorization dates and numbers

Verquvo 2.5 mg film-coated tablets: EU/1/21/1561/001–011
Verquvo 5 mg film-coated tablets: EU/1/21/1561/012–022
Verquvo 10 mg film-coated tablets: EU/1/21/1561/023–033

Drugs

Drug Countries
VERQUVO Austria, Ecuador, Estonia, Finland, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Poland, United Kingdom

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