Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Santhera Pharmaceuticals (Deutschland) GmbH, Marie-Curie Strasse 8, 79539 Lörrach, Germany, Tel: +49 (0) 7621 1690 200, Fax: +49 (0) 7621 1690 201, Email: office@santhera.com
Raxone 150 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Orange, round, biconvex film-coated tablet of 10 mm diameter, engraved with the Santhera logo on one side and ‘150’ on the other side. |
Each film-coated tablet contains 150 mg idebenone.
Excipients with known effect: Each film-coated tablet contains 46 mg of lactose (as monohydrate) and 0.23 mg of sunset yellow FCF (E110).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Idebenone |
Idebenone is an anti-oxidant assumed to be capable of transferring electrons directly to complex III of the mitochondrial electron transport chain, thereby restoring cellular energy (ATP) generation under experimental conditions of complex I deficiency. Similarly, in LHON idebenone can transfer electrons directly to complex III of the electron transport chain, thereby bypassing complex I which is affected by all three primary mtDNA mutations causing LHON, and restoring cellular ATP generation. |
| List of Excipients |
|---|
|
Tablet core: Lactose monohydrate Film-coating: Macrogol (3350) |
White high-density polyethylene bottles with white polypropylene child-resistant tamper-evident twist-off caps containing 180 film-coated tablets.
Santhera Pharmaceuticals (Deutschland) GmbH, Marie-Curie Strasse 8, 79539 Lörrach, Germany, Tel: +49 (0) 7621 1690 200, Fax: +49 (0) 7621 1690 201, Email: office@santhera.com
EU/1/15/1020/001
Date of first authorisation: 8 September 2015
| Drug | Countries | |
|---|---|---|
| RAXONE | Austria, Estonia, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom, South Africa |
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