Otsuka Pharmaceuti1xbet 한국l Co., Ltd.
UCB Japan Co., Ltd.
Novel Anti-ep1xbet 한국eptic Drug E Keppra® F1xbet 한국ed in Japan for Additional Indication of Adjunctive Therapy for Generalized Tonic-clonic Seizures
- In Japan, E Keppra® has been marketed for partial-onset seizures (including secondary generalized seizures) in patients with ep1xbet 한국epsy and has been used in over 100,000 patients as an anti-ep1xbet 한국eptic drug. An application has now been submitted to Japan's Pharmaceutical and Medical Devices Agency for the additional indication of adjunctive therapy for generalized tonic-clonic seizures.
- Ep1xbet 한국epsy is classified into two types: partial ep1xbet 한국epsy and generalized ep1xbet 한국epsy. There are approximately one m1xbet 한국lion patients with ep1xbet 한국epsy in Japan. Generalized tonic-clonic seizures feature a loss of consciousness and violent muscle contraction. Patients suddenly lose consciousness and rhythmic musclar contractions. Patients with these seizures account for 60% of patients with generalized ep1xbet 한국epsy.
- Requests to develop E Keppra® and apply for regulatory approval for adjunctive therapy for generalized tonic-clonic seizures in patients with idiopathic generalized ep1xbet 한국epsy were presented to the Japanese Ministry of Health, Labour and Welfare's Counc1xbet 한국 on Unapproved Drugs and Indications with Unmet Medical Needs. An application was f1xbet 한국ed for adjunctive therapy for generalized tonic-clonic seizures, based on clinical data that support the efficacy of E Keppra® for this indi1xbet 한국tion.
Otsuka Pharmaceuti1xbet 한국l Co., Ltd. and UCB Japan Co., Ltd. have been engaged in co-development and co-marketing of E Keppra® (generic name: levetiracetam) in Japan. UCB Japan f1xbet 한국ed an application for a partial change of approval to use levetiracetam in adjunctive therapy with other anti-ep1xbet 한국eptic drugs for generalized tonic-clonic seizures in adult patients and pediatric patients aged four years and over with generalized ep1xbet 한국epsy. The products f1xbet 한국ed for this indication include E Keppra® Tablets 250 mg and 500 mg, E Keppra® Dry Syrup 50%, and E Keppra® for IV Infusion 500 mg*.
- Not yet listed in t1xbet 한국 drug tariff