Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Allergan Pharmaceuticals International Limited, Clonshaugh Business & Technology Park, Dublin 17, D17 E400, Ireland
Truberzi 75 mg film-coated tablets.
Truberzi 100 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Truberzi 75 mg film-coated tablets: Modified capsule-shaped, pale yellow to light-tan film-coated tablet of approximately 7 mm x 17 mm, debossed with “FX75” on one side. Truberzi 100 mg film-coated tablets: Modified capsule-shaped, pink-orange to peach film-coated tablet of approximately 8 mm x 19 mm, debossed with “FX100” on one side. |
Truberzi 75 mg film-coated tablets: Each film-coated tablet contains 75 mg of eluxadoline.
Truberzi 100 mg film-coated tablets: Each film-coated tablet contains 100 mg of eluxadoline.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Eluxadoline |
Eluxadoline is a locally acting, mixed mu opioid receptor (μOR) agonist and delta opioid receptor (δOR) antagonist. Eluxadoline is also an agonist at the kappa opioid receptor (κOR). Eluxadoline has demonstrated efficacy in normalizing GI transit and defecation in several models of stress induced or post GI inflammation-altered GI function in animals. |
| List of Excipients |
|---|
|
Silicified microcrystalline cellulose (E460) |
PCTFE/PVC/Al-blister containing 14 film-coated tablets. Pack sizes of 28, 56 and a multipack containing 168 (3 packs of 56) film-coated tablets.
Not all pack sizes may be marketed.
Allergan Pharmaceuticals International Limited, Clonshaugh Business & Technology Park, Dublin 17, D17 E400, Ireland
EU/1/16/1126/001-006
Date of first authorisation: 19 September 2016
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