STEGLATRO Film-coated tablet Ref.[8684] Active ingredients: Ertugliflozin

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

Product name and form

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.

Qualitative and quantitative composition

Steglatro 5 mg film-coated tablets

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).

Steglatro 15 mg film-coated tablets

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)
Lactose monohydrate
Sodium starch glycolate (Type A)
Magnesium stearate (E470b)

Film coating:

Hypromellose 2910/6 (E464)
Lactose monohydrate
Macrogol 3350 (E1521)
Triacetin (E1518)
Titanium dioxide (E171)
Iron oxide red (E172)

Pack sizes and marketing

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.

Marketing authorization holder

Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

Marketing authorization dates and numbers

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

Drugs

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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