Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
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’. |
Each capsule contains 30 mg of duloxetine (as hydrochloride).
Excipient(s) with known effect: Each capsule may contain up to 56 mg sucrose.
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 Capsule shell: Cymbalta 30 mg Gelatin Edible green ink contains: Black iron oxide – synthetic (E172) Cymbalta 60 mg Gelatin Edible white ink contains: Titanium dioxide (E171) |
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.
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
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
| 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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