CYMBALTA Hard gastro-resistant capsule Ref.[50032] Active ingredients: Duloxetine

Source: European Medicines Agency (EU)  Revision Year: 2021  Publisher: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands

Product name and form

Cymbalta 30 mg hard gastro-resistant capsules.

Cymbalta 60 mg hard gastro-resistant capsules.

Pharmaceutical Form

Hard gastro-resistant capsule.

Cymbalta 30 mg: Opaque white body, imprinted with ‘30 mg’ and an opaque blue cap, imprinted with ‘9543’.

Cymbalta 60 mg: Opaque green body, imprinted with ‘60 mg’ and an opaque blue cap, imprinted with ‘9542’.

Qualitative and quantitative composition

Cymbalta 30 mg

Each capsule contains 30 mg of duloxetine (as hydrochloride).

Excipient(s) with known effect: Each capsule may contain up to 56 mg sucrose.

Cymbalta 60 mg

Each capsule contains 60 mg of duloxetine (as hydrochloride).

Excipient(s) with known effect: Each capsule may contain up to 111 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:

Cymbalta 30 mg

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

Edible green ink contains:

Black iron oxide – synthetic (E172)
Yellow iron oxide – synthetic (E172)
Propylene glycol
Shellac

Cymbalta 60 mg

Gelatin
Sodium lauryl sulfate
Titanium dioxide (E171)
Indigo carmine (E132)
Yellow iron oxide (E172)
Edible white ink

Edible white ink contains:

Titanium dioxide (E171)
Propylene glycol
Shellac
Povidone

Pack sizes and marketing

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

Cymbalta 30 mg: Cymbalta 30 mg is available in packs of 7, 28 and 98 hard gastro-resistant capsules.

Cymbalta 60 mg: Cymbalta 60 mg is available in packs of 28, 56, 84 and 98 hard gastro-resistant capsules and in multipacks containing 100 (5 packs of 20) and 500 (25 packs of 20) hard gastro-resistant 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/1/04/296/001
EU/1/04/296/002
EU/1/04/296/003
EU/1/04/296/004
EU/1/04/296/005
EU/1/04/296/006
EU/1/04/296/007
EU/1/04/296/008
EU/1/04/296/009

Date of first authorisation: 17 December 2004
Date of latest renewal: 24 June 2009

Drugs

Drug Countries
CYMBALTA Austria, Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa

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