Raxone fachinformation

Author: nnik

August undefined, 2024

WebNumărul 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 … 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 …

Idebenon – Wikipedia

WebSep 9, 2024 · A total of 198 patients received treatment with Raxone and were included in the Safety Population. The mean duration of treatment in the Safety Population was … 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 … bilston glen golf shop

Santhera Completes Patient Enrollment in Phase IV Long-term

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 WebIdebenon ist ein antioxidativ wirksamer, synthetisch hergestellter Stoff, der strukturell und funktionell dem Ubichinon-10 ähnlich ist. Durch eine Hemmung der Lipidperoxidation … 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 cellulose, Croscarmellose sodium, Povidone K25, Magnesium stearate, Colloidal silica, Macrogol 3350, Poly(vinyl alcohol), Talc, Titanium dioxide, Sunset yellow FCF (E110). cynthiana water ky

Santhera Announces Phase 4 LEROS Trial with Raxone® Met …

PRILOG I. SAŽETAK OPISA SVOJSTAVA LIJEKA

WebMar 12, 2024 · Raxone (idebenone), a synthetic short-chain benzoquinone and a cofactor for the enzyme NAD(P)H:quinone oxidoreductase (NQO1), has shown to promote recovery of visual acuity by circumventing the ... WebAko ste uzeliviše leka Raxone nego što treba Ako ste uzeli više leka Raxone nego što treba, odmah obavestite svoglekara. Ako ste zaboravili da uzmetelek Raxone Ako ste zaboravili … bilston health clinic prouds laneWebMay 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 ... bilston health centre wv14 6pw

"Idebenone (pronounced eye-deb-eh-known, trade names Catena, Raxone, Sovrima, among others) is a drug that was initially developed by Takeda Pharmaceutical Company for the treatment of Alzheimer's disease and other cognitive defects. This has been met with limited success. The Swiss company Santhera Pharmaceuticals has started to investigate it for the treatment of neu… " - Raxone fachinformation

Raxone fachinformation

EC grants EU marketing authorisation for Raxone

WebRaxone ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima. 4.8 Nuspojave Sažetak sigurnosnog profila Najčešće prijavljene nuspojave idebenona bile su blagi do umjereni proljev (najčešće nije zahtijevao prekid liječenja), nazofaringitis, kašalj i bol u leđima. Tablični popis nuspojava WebApr 11, 2024 · The global Myotonic Dystrophy Treatment Market is anticipated to be worth US$ 874.39 million in 2024. With market participants’ strategic initiatives and tight regulatory framework, the global demand for Myotonic Dystrophy Treatment is expected to rise at a CAGR of 12.3% between 2024 and 2033, totaling roughly US$ 2,789.35 Million by 2033.

Did you know?

WebMar 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. 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 …

WebApr 21, 2015 · Gunnar M. Buyse, MD, PhD, Professor of Child Neurology at the University Hospitals Leuven (Belgium) and Principal Investigator for the DELOS trial, said, “Statistically significant and clinically relevant outcomes of primary and secondary endpoints coherently demonstrated that Raxone/Catena reduced the loss of respiratory function and that it was … WebJun 23, 2024 · LEROS, a Phase 4 externally-controlled open-label intervention study, was designed to confirm the efficacy of Raxone in patients with LHON after 12 months of …

WebJun 26, 2015 · Raxone will be the first treatment option for LHON and the first approved therapy for a mitochondrial disease. “This is a major breakthrough as it paves the way for the first medicinal product to become available for the treatment of a mitochondrial disease,” stated Thomas Klopstock, MD ... WebIs Raxone approved? Raxone is currently approved as a treatment for a condition called Leber’s optic neuropathy. Santhera Pharmaceuticals are seeking approval for its use in …

WebChiesi Farmaceutici, an international research focused healthcare group (Chiesi Group) has entered into an exclusive license agreement with Santhera Pharmaceutical, under which Chiesi Group will in-license an orphan drug whose active principle is idebenone for the treatment of Leber hereditary optic neuropathy (LHON), an ultrarare hereditary disease …

WebJun 7, 2024 · Raxone Tablet. Raxone is a synthetic analogue of ubiquinone (also known as Coenzyme Q10), a vital cell antioxidant and essential component of the Electron … bilston health centre opening timesWebApr 14, 2024 · Forventet dato for Medicinrådets anbefaling: 26. april 2024 Vurderingen følger Medicinrådets metodevejledning og procesvejledning for vurdering af nye lægemidler og indikationsudvidelser.. En sædvanlig proces varer op til 16 uger, fra den dag sekretariatet modtager en fyldestgørende ansøgning (dag 0), til der foreligger en anbefaling fra … bilston library onlineWebextend previous findings which demonstrated that Raxone can prevent further vision loss and promote recovery of vision in LHON patients. “Raxone® represents an indispensable … bilston hospitalWebRaxone ® 150 mg ... Fachinformation. Um Zugriff auf weiterführende Informationen zu haben, bitten wir Sie, sich über DocCheck bei uns anzumelden. Bitte haben Sie … bilston ice rinkWebRaxone 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 inherited disease … cynthiana wastewater treatment plantWebMay 23, 2024 · Santhera has announced it is licensing its LHON drug Raxone (idebenone) to Chiesi Group for an upfront payment of €44 million and milestone payments of up to €49 million, as it looks to focus ... bilston high streetWebApr 14, 2024 · Medicinrådet revurderer denne anbefaling: Medicinrådets anbefaling vedr. axicabtagene ciloleucel til diffust storcellet B-celle-lymfom, version 1.0 Revurderingen sker, fordi ansøger har indsendt en anmodning om revurdering. Revurderingen følger Medicinrådets proces- og metodevejledning for vurdering af nye lægemidler og … cynthiana water pay