YENTREVE Hard gastro-resistant capsule Ref.[6815] Active ingredients: Duloxetine

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands

Product name and form

YENTREVE 20 mg hard gastro-resistant capsules.

Pharmaceutical Form

Hard gastro-resistant capsule.

Opaque blue body, imprinted with ‘20 mg’ and an opaque blue cap, imprinted with ‘9544’.

Qualitative and quantitative composition

Each capsule contains 20 mg of duloxetine (as hydrochloride).

Excipient(s) with known effect: Each capsule may contain up to 37 mg sucrose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Duloxetine

Duloxetine is a combined serotonin (5-HT) and noradrenaline (NA) reuptake inhibitor. It weakly inhibits dopamine reuptake with no significant affinity for histaminergic, dopaminergic, cholinergic and adrenergic receptors.

List of Excipients

Capsule content:

Hypromellose
Hypromellose acetate succinate
Sucrose
Sugar spheres
Talc
Titanium dioxide (E171)
Triethyl citrate

Capsule shell:

Gelatin
Sodium lauryl sulfate
Titanium dioxide (E171)
Indigo carmine (E132)
Edible black ink

Edible ink:

Black iron oxide – synthetic (E172)
Propylene glycol
Shellac

Pack sizes and marketing

Polyvinylchloride (PVC), polyethylene (PE), and polychlorotrifluoroethylene (PCTFE) blister sealed with an aluminium foil.

Packs of 28, 56 and 98 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands

Marketing authorization dates and numbers

EU/1/04/280/001
EU/1/04/280/007
EU/1/04/280/008

Date of first authorisation: 11 August 2004
Date of latest renewal: 24 June 2009

Drugs

Drug Countries
YENTREVE Austria, Germany, Estonia, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Poland, United Kingdom

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