Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: AstraZeneca AB, SE-151 85, Södertälje, Sweden
Onglyza 2.5 mg film-coated tablets.
Onglyza 5 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Onglyza 2.5 mg film-coated tablets: Onglyza 2.5 mg tablets are pale yellow to light yellow, biconvex, round, film-coated tablets, with “2.5” printed on one side and “4214” printed on the other side, in blue ink. Onglyza 5 mg film-coated tablets: Onglyza 5 mg tablets are pink, biconvex, round, film-coated tablets, with “5” printed on one side and “4215” printed on the other side, in blue ink. |
Onglyza 2.5 mg film-coated tablets: Each tablet contains 2.5 mg saxagliptin (as hydrochloride).
Onglyza 5 mg film-coated tablets: Each tablet contains 5 mg saxagliptin (as hydrochloride).
Excipient(s) with known effect:
Each tablet contains 99 mg lactose (as monohydrate).
Onglyza contains less than 1 mmol sodium (23 mg) per dose, i.e. is essentially ‘sodium-free’.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Saxagliptin |
Saxagliptin is a highly potent (Ki: 1.3 nM), selective, reversible, competitive, DPP4 inhibitor. Saxagliptin improves glycaemic control by reducing fasting and postprandial glucose concentrations in patients with type 2 diabetes. |
| List of Excipients |
|---|
|
Tablet core: Lactose monohydrate Film-coating: Onglyza 2.5 mg film-coated tablets: Polyvinyl alcohol Onglyza 5 mg film-coated tablets: Polyvinyl alcohol Printing ink: Shellac |
Alu/Alu blister.
Onglyza 2.5 mg film-coated tablets:
Pack sizes of 14, 28, and 98 film-coated tablets in non-perforated calendar blisters.
Pack sizes of 30x1 and 90x1 film-coated tablets in perforated unit dose blisters.
Not all pack sizes may be marketed.
Onglyza 5 mg film-coated tablets:
Pack sizes of 14, 28, 56 and 98 film-coated tablets in non-perforated blisters.
Pack sizes of 14, 28, 56 and 98 film-coated tablets in non-perforated calendar blisters.
Pack sizes of 30x1 and 90x1 film-coated tablets in perforated unit dose blisters.
Not all pack sizes may be marketed.
AstraZeneca AB, SE-151 85, Södertälje, Sweden
Onglyza 2.5 mg film-coated tablets:
EU/1/09/545/011 14 film-coated tablets (calendar blister)
EU/1/09/545/012 28 film-coated tablets (calendar blister)
EU/1/09/545/013 98 film-coated tablets (calendar blister)
EU/1/09/545/014 30x1 (unit dose) film-coated tablets
EU/1/09/545/015 90x1 (unit dose) film-coated tablets
Onglyza 5 mg film-coated tablets:
EU/1/09/545/001 14 film-coated tablets
EU/1/09/545/002 28 film-coated tablets
EU/1/09/545/003 56 film-coated tablets
EU/1/09/545/004 98 film-coated tablets
EU/1/09/545/005 14 film-coated tablets (calendar blister)
EU/1/09/545/006 28 film-coated tablets (calendar blister)
EU/1/09/545/007 56 film-coated tablets (calendar blister)
Date of first authorisation: 01 October 2009
Date of latest renewal: 18 July 2014
| Drug | Countries | |
|---|---|---|
| ONGLYZA | Austria, Australia, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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