- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
The marketing authorisation for Starlix has been withdrawn at the request of the marketing-authorisation holder.
Starlix : EPAR - Summary for the public
English (EN) (613.12 KB - PDF)
български (BG) (787.46 KB - PDF)
español (ES) (616.32 KB - PDF)
čeština (CS) (767.27 KB - PDF)
dansk (DA) (615.69 KB - PDF)
Deutsch (DE) (617.69 KB - PDF)
eesti keel (ET) (615.69 KB - PDF)
ελληνικά (EL) (793.93 KB - PDF)
français (FR) (617.14 KB - PDF)
italiano (IT) (616.16 KB - PDF)
latviešu valoda (LV) (771.88 KB - PDF)
lietuvių kalba (LT) (732.44 KB - PDF)
magyar (HU) (758.59 KB - PDF)
Malti (MT) (769.36 KB - PDF)
Nederlands (NL) (616.82 KB - PDF)
polski (PL) (774.47 KB - PDF)
português (PT) (617.04 KB - PDF)
română (RO) (726.33 KB - PDF)
slovenčina (SK) (763.18 KB - PDF)
slovenščina (SL) (744.45 KB - PDF)
Suomi (FI) (616.11 KB - PDF)
svenska (SV) (615.7 KB - PDF)
Product information
Starlix : EPAR - Product Information
English (EN) (1.11 MB - PDF)
български (BG) (2.05 MB - PDF)
español (ES) (1.17 MB - PDF)
čeština (CS) (1.76 MB - PDF)
dansk (DA) (1.1 MB - PDF)
Deutsch (DE) (1.12 MB - PDF)
eesti keel (ET) (1.08 MB - PDF)
ελληνικά (EL) (2.1 MB - PDF)
français (FR) (1.22 MB - PDF)
hrvatski (HR) (1.22 MB - PDF)
íslenska (IS) (1.09 MB - PDF)
italiano (IT) (1.17 MB - PDF)
latviešu valoda (LV) (1.81 MB - PDF)
lietuvių kalba (LT) (1.24 MB - PDF)
magyar (HU) (1.77 MB - PDF)
Malti (MT) (1.8 MB - PDF)
Nederlands (NL) (1.11 MB - PDF)
norsk (NO) (1.15 MB - PDF)
polski (PL) (1.76 MB - PDF)
português (PT) (1.13 MB - PDF)
română (RO) (1.23 MB - PDF)
slovenčina (SK) (1.77 MB - PDF)
slovenščina (SL) (1.72 MB - PDF)
Suomi (FI) (1.09 MB - PDF)
svenska (SV) (1.23 MB - PDF)
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Starlix : EPAR - All Authorised presentations
English (EN) (583.78 KB - PDF)
български (BG) (674.04 KB - PDF)
español (ES) (584.08 KB - PDF)
čeština (CS) (629.08 KB - PDF)
dansk (DA) (578.44 KB - PDF)
Deutsch (DE) (583.5 KB - PDF)
ελληνικά (EL) (741.64 KB - PDF)
français (FR) (584.72 KB - PDF)
italiano (IT) (585.43 KB - PDF)
latviešu valoda (LV) (669.3 KB - PDF)
lietuvių kalba (LT) (654.3 KB - PDF)
magyar (HU) (666.1 KB - PDF)
Malti (MT) (664.54 KB - PDF)
Nederlands (NL) (584.28 KB - PDF)
polski (PL) (630.62 KB - PDF)
português (PT) (584.46 KB - PDF)
română (RO) (648.17 KB - PDF)
slovenčina (SK) (629.5 KB - PDF)
slovenščina (SL) (618.03 KB - PDF)
Suomi (FI) (584.58 KB - PDF)
svenska (SV) (582.36 KB - PDF)
Product details
- Name of medicine
- Starlix
- Active substance
- nateglinide
- International non-proprietary name (INN) or common name
- nateglinide
- Therapeutic area (MeSH)
- Diabetes Mellitus, Type 2
- Anatomical therapeutic chemical (ATC) code
- A10BX03
Pharmacotherapeutic group
Drugs used in diabetesTherapeutic indication
Nateglinide is indicated for combination therapy with metformin in type-2 diabetic patients inadequately controlled despite a maximally tolerated dose of metformin alone.
Authorisation details
- EMA product number
- EMEA/H/C/000335
- Marketing authorisation holder
- Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland - Marketing authorisation issued
- 03/04/2001
- Revision
- 15
Assessment history
More information on Starlix
Public statement on Starlix : Withdrawal of the marketing authorisation in the European Union
English (EN) (124.69 KB - PDF)