ENYGLID Tablet Ref.[27734] Active ingredients: Repaglinide

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Product name and form

Enyglid 0.5 mg tablets.
Enyglid 1 mg tablets.
Enyglid 2 mg tablets.

Pharmaceutical Form

Tablet.

Enyglid 0.5 mg tablets: The tablets are white, round and biconvex with bevelled edges.

Enyglid 1 mg tablets: The tablets are pale brown-yellow, round, biconvex with bevelled edges and possible darker spots.

Enyglid 2 mg tablets: The tablets are pink, marbled, round, biconvex with bevelled edges and possible darker spots.

Qualitative and quantitative composition

Enyglid 0.5 mg tablets: Each tablet contains 0.5 mg repaglinide.

Enyglid 1 mg tablets: Each tablet contains 1 mg repaglinide.

Enyglid 2 mg tablets: Each tablet contains 2 mg repaglinide.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Repaglinide

Repaglinide is a short-acting oral secretagogue. Repaglinide lowers the blood glucose levels acutely by stimulating the release of insulin from the pancreas, an effect dependent upon functioning β-cells in the pancreatic islets.

List of Excipients

Microcrystalline cellulose (E460)
Calcium hydrogen phosphate
Croscarmellose sodium
Povidone K25
Glycerol
Magnesium stearate
Meglumine
Poloxamer
Yellow iron oxide (E172) – only in 1 mg tablets
Red iron oxide (E172) – only in 2 mg tablets

Pack sizes and marketing

Blister pack (OPA/Alu/PVC-Alu): 30, 60, 90, 120, 180, 270 and 360 tablets in the box.

Not all pack sizes may be marketed.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Marketing authorization dates and numbers

Enyglid 0.5 mg tablets

30 tablets: EU/1/09/580/001
60 tablets: EU/1/09/580/002
90 tablets: EU/1/09/580/003
120 tablets: EU/1/09/580/004
180 tablets: EU/1/09/580/019
270 tablets: EU/1/09/580/005
360 tablets: EU/1/09/580/006

Enyglid 1 mg tablets

30 tablets: EU/1/09/580/007
60 tablets: EU/1/09/580/008
90 tablets: EU/1/09/580/009
120 tablets: EU/1/09/580/010
180 tablets: EU/1/09/580/020
270 tablets: EU/1/09/580/011
360 tablets: EU/1/09/580/012

Enyglid 2 mg tablets

30 tablets: EU/1/09/580/013
60 tablets: EU/1/09/580/014
90 tablets: EU/1/09/580/015
120 tablets: EU/1/09/580/016
180 tablets: EU/1/09/580/021
270 tablets: EU/1/09/580/017
360 tablets: EU/1/09/580/018

Date of first authorisation: 14/10/2009
Date of latest renewal: 22 August 2014

Drugs

Drug Countries
ENYGLID Austria, Cyprus, Estonia, Ireland, Lithuania, Poland, United Kingdom

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