MULTAQ Film-coated tablets Ref.[6810] Active ingredients: Dronedarone

Source: European Medicines Agency (EU)  Revision Year: 2018  Publisher: sanofi-aventis groupe, 54, rue La Boétie, F-75008, Paris, France

Product name and form

MULTAQ 400 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (tablet).

White, oblong shaped tablets, engraved with a double wave marking on one side and "4142"code on the other side.

Qualitative and quantitative composition

Each tablet contains 400 mg of dronedarone (as hydrochloride).

Excipient with known effect: Each tablet also contains 41.65 mg of lactose (as monohydrate).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Dronedarone

Dronedarone is a multichannel blocker inhibiting the potassium currents (including IK(Ach), IKur, IKr, IKs) and thus prolonging cardiac action potential and refractory periods (Class III). It also inhibits the sodium currents (Class Ib) and the calcium currents (Class IV). It non-competitively antagonises adrenergic activities (Class II).
List of Excipients

Tablet core:

Hypromellose (E464)
Maize starch
Crospovidone (E1202)
Poloxamer 407
Lactose monohydrate
Colloidal anhydrous silica
Magnesium stearate(E572)

Tablet coat:

Hypromellose (E464)
Macrogol 6000
Titanium dioxide (E171)
Carnauba wax (E903)

Pack sizes and marketing

  • Opaque PVC/Aluminium blister in packs of 20, 50 and 60 film-coated tablets.
  • Opaque PVC/Aluminium perforated unit dose blister in packs of 100x1 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

sanofi-aventis groupe, 54, rue La Boétie, F-75008, Paris, France

Marketing authorization dates and numbers

EU/1/09/591/001 – Cartons of 20 film-coated tablets
EU/1/09/591/002 – Cartons of 50 film-coated tablets
EU/1/09/591/003 – Cartons of 60 film-coated tablets
EU/1/09/591/004 – Cartons of 100 × 1 film-coated tablets

Date of first authorisation: 26 November 2009

Date of latest renewal: 22 September 2014

Drugs

Drug Countries
MULTAQ Austria, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Italy, Lithuania, Poland, Singapore, United Kingdom, United States
 
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