Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
STRATTERA 10mg, 18mg, 25mg, 40mg, 60mg, 80mg or 100mg hard capsules.
| Pharmaceutical Form |
|---|
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Capsule, hard. STRATTERA 10 mg capsules: hard capsule, opaque white, imprinted with “Lilly 3227” and “10 mg” in black ink, approximately 15.5-16.1 mm length. STRATTERA 18 mg capsules: hard capsule, gold (cap) and opaque white (body), imprinted with “Lilly 3238” and “18 mg” in black ink, approximately 15.5-16.1 mm length. STRATTERA 25 mg capsules: hard capsule, opaque blue (cap) and opaque white (body), imprinted with “Lilly 3228” and “25 mg” in black ink, approximately 15.5-16.1 mm length. STRATTERA 40 mg capsules: hard capsule, opaque blue, imprinted with “Lilly 3229” and “40 mg” in black ink, approximately 15.5-16.1 mm length. STRATTERA 60 mg capsules: hard capsule, opaque blue (cap) and gold (body), imprinted with “Lilly 3239” and “60 mg” in black ink, approximately 17.5-18.1 mm length. STRATTERA 80 mg capsules: hard capsule, opaque brown (cap) and opaque white (body), imprinted with “Lilly 3250” and “80 mg” in black ink, approximately 17.5-18.1 mm length. STRATTERA 100 mg capsules: hard capsule, opaque brown, imprinted with “Lilly 3251” and “100 mg” in black ink, approximately 19.2-19.8 mm length. |
Each hard capsule contains atomoxetine hydrochloride equivalent to 10mg, 18mg, 25mg, 40mg, 60mg, 80mg or 100mg of atomoxetine.
For the full list of excipients, see Section 6.1.
| Active Ingredient |
|---|
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Atomoxetine is a highly selective and potent inhibitor of the pre-synaptic noradrenaline transporter, its presumed mechanism of action, without directly affecting the serotonin or dopamine transporters. |
| List of Excipients |
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Starch, pregelatinised (Maize) Capsule shell: Sodium laurilsulfate Capsule shell cap colourants: 10 mg: Titanium dioxide E171 18 mg: Yellow iron oxide E172 25 mg, 40 mg, and 60 mg: FD&C Blue 2 (Indigo Carmine) E132 and Titanium dioxide E171 80 mg and 100 mg: Yellow iron oxide E172, Red iron oxide E172, Titanium dioxide E171 Capsule Shell Body colourants: 60 mg: Yellow iron oxide E172 10 mg, 18 mg, 25 mg and 80 mg: Titanium dioxide E171 40 mg: FD&C Blue 2 (Indigo Carmine) E132 and Titanium dioxide E171 100 mg: Yellow iron oxide E172, Red iron oxide E172, Titanium dioxide E171 Edible Black Ink SW-9008 (containing Shellac and Black Iron Oxide E172) or Edible Black Ink SW-9010 (containing Shellac and Black Iron Oxide E172). |
Polyvinyl chloride (PVC)/polyethylene (PE)/ Polychlorotrifluoroethylene, PCTFE blister sealed with aluminium foil lid.
Available in pack sizes of 7, 14, 28 and 56 capsules. Not all pack sizes may be marketed.
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
STRATTERA 10 mg hard capsules: PL 14895/0303
STRATTERA 18 mg hard capsules: PL 14895/0304
STRATTERA 25 mg hard capsules: PL 14895/0305
STRATTERA 40 mg hard capsules: PL 14895/0306
STRATTERA 60 mg hard capsules: PL 14895/0307
STRATTERA 80 mg hard capsules: PL 14895/0308
STRATTERA 100 mg hard capsules: PL 14895/0309
Date of first authorisation: 27 May 2004
Date of latest renewal: 27 May 2014
| Drug | Countries | |
|---|---|---|
| STRATTERA | Austria, Australia, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, Hong Kong, Ireland, Israel, Japan, Lithuania, Malta, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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