Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
STARLIX 60 mg film-coated tablets.
STARLIX 120 mg film-coated tablets.
STARLIX 180 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. STARLIX 60 mg film-coated tablets: 60 mg pink, round, bevelled-edge tablets with “STARLIX” marked on one side and “60” on the other. STARLIX 120 mg film-coated tablets: 120 mg yellow, ovaloid tablets with “STARLIX” marked on one side and “120” on the other. STARLIX 180 mg film-coated tablets: 180 mg red, ovaloid tablets with “STARLIX” marked on one side and “180” on the other. |
STARLIX 60 mg film-coated tablets: Each film-coated tablet contains 60 mg nateglinide.
Excipient with known effect: Lactose monohydrate: 141.5 mg per tablet.
STARLIX 120 mg film-coated tablets: Each film-coated tablet contains 120 mg nateglinide.
Excipient with known effect: Lactose monohydrate: 283 mg per tablet.
STARLIX 180 mg film-coated tablets: Each film-coated tablet contains 180 mg nateglinide.
Excipient with known effect: Lactose monohydrate: 214 mg per tablet.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Nateglinide |
Nateglinide is an amino acid (phenylalanine) derivative, which is chemically and pharmacologically distinct from other antidiabetic agents. Nateglinide is a rapid, short-acting oral insulin secretagogue. Its effect is dependent on functioning beta cells in the pancreas islets. |
| List of Excipients |
|---|
|
STARLIX 60 mg film-coated tablets: Lactose monohydrate STARLIX 120 mg film-coated tablets: Lactose monohydrate STARLIX 180 mg film-coated tablets: Lactose monohydrate |
Blisters: PVC/PE/PVDC blisters, backed with a heat-sealable lacquered aluminium foil.
Packs contain 12, 24, 30, 60, 84, 120 and 360 tablets.
Not all pack sizes may be marketed.
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
STARLIX 60 mg film-coated tablets: EU/1/01/174/001-007
STARLIX 120 mg film-coated tablets: EU/1/01/174/008-014
STARLIX 180 mg film-coated tablets: EU/1/01/174/015-021
Date of first authorisation: 03 April 2001
Date of latest renewal: 24 April 2006
| Drug | Countries | |
|---|---|---|
| STARLIX | Austria, Cyprus, Estonia, Ireland, Lithuania, Poland, Romania, Singapore, United States, South Africa |
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