Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Guidehouse Germany GmbH, Albrechtstr. 10c, 10117 Berlin, Germany
Zynquista 200 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Oval, blue, film-coated tablet printed with “2456” on one side in black ink (tablet length: 14.2 mm, tablet width: 8.7 mm). |
Each tablet contains 200 mg sotagliflozin.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Sotagliflozin |
Sotagliflozin is an inhibitor of SGLT2 and SGLT1. Inhibiting SGLT2 reduces renal reabsorption of glucose and sodium which may influence several physiological functions such as lowering both pre-and afterload of the heart and downregulating sympathetic activity. Inhibiting SGLT1 reduces intestinal absorption of glucose and sodium which likely contributes to diarrhea. The mechanism for sotagliflozin’s cardiovascular benefits has not been established. |
| List of Excipients |
|---|
|
Tablet core: Microcrystalline cellulose (E460i) Film-coating: Poly(vinyl alcohol) Printing ink: Shellac |
PVC/PCTFE/Aluminium opaque blisters.
Pack sizes of 10, 20, 30, 60, 90, 100, 180 film-coated tablets, and a multipack of 200 film-coated tablets (2 packs of 100 film-coated tablets).
Not all pack sizes may be marketed.
Guidehouse Germany GmbH, Albrechtstr. 10c, 10117 Berlin, Germany
Zynquista 200 mg film coated tablets:
EU/1/19/1363/001 10 film coated tablets
EU/1/19/1363/002 20 film coated tablets
EU/1/19/1363/003 30 film coated tablets
EU/1/19/1363/004 60 film coated tablets
EU/1/19/1363/005 90 film coated tablets
EU/1/19/1363/006 100 film coated tablets
EU/1/19/1363/007 180 film coated tablets
EU/1/19/1363/008 200 (2x100) film coated tablets (multipack)
Date of first authorisation: 26 April 2019
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