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法国赛诺菲喜保宁在中国获批上市了吗?

Author: Medicalhalo
Release time: 2025-10-19 11:44:20

(Vigabatrin tablets) are analogs of the inhibitory neurotransmitter γ-aminobutyric acid (GABA). They reduce the degradation of GABA by irreversibly binding to GABA transaminase, thereby increasing the level of GABA in the central nervous system and exerting anti-epileptic effects. Indications for vigabatrin include monotherapy for infantile spasms in children aged 1 month to 2 years and add-on therapy in patients over 10 years old with complex partial epilepsy. It is currently recommended as first-line treatment for infantile spasms, and the drug of choice for epileptic spasms also includes Vigabatrin. So, has France's Sanofi Vigabatrin been approved for marketing in China?

So far, France's Sanofi Vigabatrin has been launched in many countries and regions, but it has not yet been approved by the National Medical Products Administration (NMPA) to be officially launched in China. Therefore, patients who currently need this drug for treatment can only first purchase drugs overseas to meet their needs.

According to Medical Companion Travel, a box of the Turkish version of Vigabatrin exported to France by Sanofi is priced at around $1,500, and the drug specification is 500 mg x 100 capsules per box. Domestic patients in need can either go abroad to purchase local medicines in person, or contact some professional and formal overseas medical service organizations in China (such as Medical Companion Travel) to obtain purchase channels for the required medicines.

French Sanofi is the third largest pharmaceutical company in the world. It was formed by the merger of Sanofi-Synthelabo and Aventis. It ranks first in Europe, with branches in more than 80 countries and more than 100,000 employees. Vigabatrin produced by it is currently the only drug approved by regulatory authorities in various countries for the treatment of infantile spasms (IS). It has definite efficacy. However, if the disease is not treated, the prognosis is very poor, and there is a serious risk of disability or even death. For refractory complex partial-onset epilepsy (CPS), there are currently relatively many treatment options available, which can be used as second- or third-line drugs when other drugs are ineffective.

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