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Imported medicine’s clinical use approved in Shenzhen

2022-02-16 Source: Szdaily.com

SABRIL (vigabatrin), an anticonvulsant medication, has been introduced to Shenzhen through the “Hong Kong and Macao Medicine and Equipment Connect” policy and has been put into clinical use at the University of Hong Kong-Shenzhen Hospital (HKU-SZH), the hospital announced recently.

The first batch of the medication was purchased from abroad following the approval of the provincial drug regulator. Previously, the medication was unavailable on the Chinese mainland.

According to the hospital, five young patients had taken the medicine as of Monday and had given positive feedbacks.

Sabril (vigabatrin), approved by the U.S. Food and Drug Administration (FDA) in August 2009, is used as a monotherapy in children from 1 month to 2 years old who suffer from infantile spasms, a form of epilepsy.

Infantile spasms are associated with a poor prognosis that includes neurodevelopmental regression and a significant mortality rate, according to information from the FDA. Furthermore, infantile spasms are usually linked to tuberous sclerosis, a rare genetic disorder that causes growth of benign tumors.

HKU-SZH reminded that children with infantile spasms or other epilepsy patients from across the country can visit the hospital’s epilepsy specialist clinic for medical advice if necessary, and can be given the medication after a doctor’s consultation and evaluation.

Medications prescribed for the first time at HKU-SZH must be taken in the presence of medical staff, according to current regulations on the use of medicines under the “Hong Kong and Macao Medicine and Equipment Connect” policy.

HKU-SZH, the health policy’s testing ground, revealed that it has introduced 13 medicines and three medical devices to the mainland under the policy, benefiting more than 200 patients.