In September 2015, Raxone® received European marketing authorization for the treatment of patients with Leber's hereditary optic neuropathy (LHON). This makes Raxone (idebenone 150 mg) the first and only medicine approved for this condition. Effective August 1, 2019, Santhera has licensed its rights for the development, commercialization and distribution of Raxone for the treatment of LHON and any other potential ophthalmological indications to Chiesi Group for all territories worldwide except the US and Canada. In an interim phase, Santhera remains the EU marketing authorization holder and will continue to commercialize Raxone for LHON in France.
▼The European Medicines Agency (EMA) has indicated that this medicine is subject to additional monitoring.
Santhera Pharmaceuticals (Deutschland) GmbH
Marie-Curie Strasse 8, 79539 Lörrach – Germany
Phone: +49 7621 1690 200
Fax: +49 7621 1690 201
The Summary of Product Characteristics can be viewed by clicking here.
Reporting suspected adverse reactions after authorization of the medicinal product is important as this will allow quick identification of new safety information. Reporting of adverse reactions should be done according to applicable regulations in your country. Contact details to report any suspected adverse reactions to Raxone to Santhera can be found here.
Raxone’s quality is assured by Santhera’s rigorous manufacturing processes and a tightly controlled supply that meet all pharmaceutical medical standards and regulatory requirements.
All countries outside North America, France and some Eastern EU/European countries
26/A, Via Palermo, 43122 Parma – Italy
Phone: +39 0521 2791
Fax: +39 0521 774468
France, North America
For availability in France please contact firstname.lastname@example.org.
For questions relating to the US and Canada, where Raxone/idebenone is NOT approved for use and NOT available for purchase, please contact email@example.com. For medical inquiries regarding idebenone, please call: +1 800 887 6915.
Eastern EU/European countries
For availability in EU-countries Bulgaria, Croatia, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Slovakia, Slovenia, and Eastern European countries Bosnia and Herzegovina, North Macedonia, Moldova, Montenegro, Serbia and Ukraine please contact firstname.lastname@example.org.
Vordergasse 43, 8200 Schaffhausen – Switzerland
Phone: +41 52 633 09 99