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VIPIDIA Film-coated tablets (2018)

Active ingredients: Alogliptin

Product Name and Form

Vipidia 6.25 mg film-coated tablets.

Vipidia 12.5 mg film-coated tablets.

Vipidia 25 mg film-coated tablets.

Pharmaceutical form

Film-coated tablet (tablet).

Vipidia 6.25 mg film-coated tablets: Light pink, oval (approximately 9.1 mm long by 5.1 mm wide), biconvex, film-coated tablets with “TAK” and “ALG-6.25” printed in grey ink on one side.

Vipidia 12.5 mg film-coated tablets: Yellow, oval (approximately 9.1 mm long by 5.1 mm wide), biconvex, film-coated tablets with “TAK” and “ALG-12.5” printed in grey ink on one side.

Vipidia 25 mg film-coated tablets: Light red, oval (approximately 9.1 mm long by 5.1 mm wide), biconvex, film-coated tablets with “TAK” and “ALG-25” printed in grey ink on one side.

Qualitative and Quantitative Composition

Vipidia 6.25 mg film-coated tablets: Each tablet contains alogliptin benzoate equivalent to 6.25 mg alogliptin.

Vipidia 12.5 mg film-coated tablets: Each tablet contains alogliptin benzoate equivalent to 12.5 mg alogliptin.

Vipidia 25 mg film-coated tablets: Each tablet contains alogliptin benzoate equivalent to 25 mg alogliptin.

For the full list of excipients, see section 6.1.

Chemical substance
Description
Alogliptin

Alogliptin is a potent and highly selective inhibitor of DPP-4, >10,000-fold more selective for DPP-4 than other related enzymes including DPP-8 and DPP-9. Alogliptin improves glycaemic control via a glucose-dependent mechanism, whereby insulin release is enhanced and glucagon levels are suppressed when glucose levels are high.

List of excipients

Tablet core:

Mannitol
Microcrystalline cellulose
Hydroxypropylcellulose
Croscarmellose sodium
Magnesium stearate

Film-coating:

Hypromellose
Titanium dioxide (E171)
Iron oxide red (E172)
Iron oxide yellow (E172)
Macrogol 8000

Printing ink:

Shellac
Iron oxide black (E172)

Pack sizes and Marketing

Polychlorotrifluoroethylene (PCTFE)/polyvinyl chloride (PVC) blisters with push through aluminium lidding foil. Pack sizes of 10, 14, 28, 30, 56, 60, 84, 90, 98 or 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Takeda Pharma A/S, Dybendal Alle 10, 2630, Taastrup, Denmark

Date of first authorisation: 19 September 2013

Marketing authorization number:

EU/1/13/844/001-030