Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Steglatro 5 mg film-coated tablets.
Steglatro 15 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Steglatro 5 mg film-coated tablets: Pink, 6.4 × 6.6 mm, triangular-shaped, film-coated tablets debossed with “701” on one side and plain on the other side. Steglatro 15 mg film-coated tablets: Red, 9.0 × 9.4 mm, triangular-shaped, film-coated tablets debossed with “702” on one side and plain on the other side. |
Each tablet contains ertugliflozin L-pyroglutamic acid, equivalent to 5 mg ertugliflozin.
Excipient with known effect: Each tablet contains 28 mg of lactose (as monohydrate).
Each tablet contains ertugliflozin L-pyroglutamic acid, equivalent to 15 mg ertugliflozin.
Excipient with known effect: Each tablet contains 85 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Ertugliflozin |
Ertugliflozin helps to lower blood glucose by making the patient pass out glucose in the urine. It does this by blocking a protein in the kidneys (called SGLT2) that normally takes glucose back into the blood from the kidneys. |
| List of Excipients |
|---|
|
Tablet core: Microcrystalline cellulose (E460) Film coating: Hypromellose 2910/6 (E464) |
Alu/PVC/PA/Alu blisters.
Packs of 14, 28, 30, 84, 90 and 98 film-coated tablets in non-perforated blisters.
Packs of 30x1 film-coated tablets in perforated unit dose blisters.
Not all pack sizes may be marketed.
Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Steglatro 5 mg film-coated tablets:
EU/1/18/1267/001
EU/1/18/1267/002
EU/1/18/1267/003
EU/1/18/1267/004
EU/1/18/1267/005
EU/1/18/1267/006
EU/1/18/1267/013
Steglatro 15 mg film-coated tablets:
EU/1/18/1267/007
EU/1/18/1267/008
EU/1/18/1267/009
EU/1/18/1267/010
EU/1/18/1267/011
EU/1/18/1267/012
EU/1/18/1267/014
Date of first authorisation: 21 March 2018
Date of latest renewal: 15 November 2022
| Drug | Countries | |
|---|---|---|
| STEGLATRO | Austria, Australia, Cyprus, Estonia, Spain, Finland, Hong Kong, Ireland, Israel, Lithuania, Netherlands, Poland, Romania, United Kingdom, United States |
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