Raxone fachinformation
Web- RAXONE (CAP) - PSUSA/00010412/202409 Applicant: Santhera Pharmaceuticals (Deutschland) GmbH PRAC Rapporteur: Amelia Cupelli . Scope: Evaluation of a PSUSA procedure . Action: For adoption of recommendation to CHMP . 13. Centrally authorised product(s) only . 14. Centrally authorised product(s) only WebMay 16, 2016 · Hypersensitivity to the active substance or to any of the following excipients (as listed in section 6.1 of Raxone SmPC): Lactose monohydrate, Microcrystalline …
Raxone fachinformation
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WebSep 17, 2024 · Raxone is a medicine used to treat visual impairment in adults and adolescents aged 12 years and over with Leber’s hereditary optic neuropathy (LHON), an … WebIntroduction: Leber's Hereditary Optic Neuropathy (LHON) causes a rapid and severe decrease in visual acuity. Raxone ® (Idebenone, Santhera) is the only drug to have a European Marketing Authorization for the treatment of this optic neuropathy. It can be proposed in the first months after the onset of this optic neuropathy, according to an …
WebNov 8, 2024 · Below is a text only representation of the Patient Information Leaflet (ePIL). The text only version may be available in large print, Braille or audio CD . For further … WebSep 9, 2015 · Raxone a ‘major breakthrough’ in mitochondrial disease treatment “Raxone represents a major breakthrough in mitochondrial disease treatment, and its approval paves the way for patients with LHON to be treated and to achieve a meaningful improvement of their visual acuity,” said Thomas Klopstock, MD, Professor for Neurology at the University …
WebMay 22, 2014 · A total of 93.8% of Catena ® /Raxone ® -treated and 94.1% of placebo-treated patients experienced at least one Adverse Event (AE). Serious AEs were reported in 6.3% of Catena ® /Raxone ... WebRaxone® (idebenone) is a drug that is thought to preserve mitochondrial function and it is believed that Raxone® can prevent cell damage and increase the production of energy …
WebSep 8, 2016 · About Raxone ® (Idebenone) in Duchenne Muscular Dystrophy Duchenne muscular dystrophy (DMD) is one of the most common and devastating types of muscle degeneration and results in rapidly ...
WebJun 21, 2024 · 26 October 2024. Removal of scientific opinion for Raxone due to discontinuation of EAMS programme at the request of the company. 22 June 2024. The Annex to Public Assessment Report THIRD RENEWAL ... literacy vocabulary listWebIdebenon ist ein antioxidativ wirksamer, synthetisch hergestellter Stoff, der strukturell und funktionell dem Ubichinon-10 ähnlich ist. Durch eine Hemmung der Lipidperoxidation … importance of digital literacy in pointsWebMar 3, 2024 · RAXONE (idebenone) is a first-line therapy in the treatment of visual impairment in adolescent and adult patients with Leber's hereditary optic neuropathy (LHON). Clinical Benefit. Moderate: The Committee deems that the clinical benefit of RAXONE 150 mg (idebenone) film-coated tablets is moderate in the MA indication. literacy volunteers and advocates dcWebRaxone ist ein Arzneimittel zur Behandlung von Sehstörungen bei Erwachsenen und Jugendlichen ab 12 Jahren mit Leberscher hereditärer Optikusneuropathie (LHON), einer … importance of digital literacy for nursesWebBislang haben sechs Wirkstoffe der Augenheilkunde in elf Anwendungsgebieten die frühe Nutzenbewertung nach § 35a SGB V durchlaufen. Nur für einen Wirkstoff (Ocriplasmin) … literacy volunteers buffaloWebNumărul autorizației de punere pe piață (UE) Numele (inventat) Concentrația Forma farmaceutică Calea de administrare Ambalajul primar Mărimea ambalajului EU/1/15/1020/001 Raxone 150 mg Comprimat filmat Administrare orală … importance of digital libraryWebJun 23, 2024 · Santhera Pharmaceuticals announces positive topline results from itslong-term Phase 4 LEROS study with Raxone® in the treatment of Leber’s hereditary optic … literacy volunteers charlottesville albemarle