Now, the 109 items of 'amlodipine besylate' monotherapy, which is used for the treatment of hypertension and angina, can be used for treating pediatric patients with hypertension.

The Ministry of Food and Drug Safety (MFDS) ordered the change of approval conditions for 'amlodipine besylate monotherapy (doses 5mg, 10mg, tab)'. The change of approval conditions will be in effect starting May 2nd.

According to the details of the change of approval conditions, the previous precaution, 'Safety and efficacy have not been established in pediatric patients,' has been revised to 'This medication (2.5 mg-5 mg per day) has a blood pressure-lowering effect in patients aged 6-17 years.'