PMDA drug package insert

レベチラセタム錠250mg「サンド」

PMDA Prescription drug · サンド株式会社 · package insert Mar 17, 2026

Key facts

Brand names レベチラセタム錠250mg「サンド」, レベチラセタム錠500mg「サンド」
Nonproprietary names レベチラセタム
Companies 製造販売/サンド株式会社
Product type Prescription drug
Therapeutic category 抗てんかん剤
Therapeutic category codes 871139
YJ codes 1139010F1148, 1139010F2144
Approval numbers 30400AMX00044000, 30400AMX00045000
Package insert edition 第3版
Package insert date Mar 17, 2026
PMDA document key 270428_1139010F1148_1
PMDA company code 270428

At a glance

  • 1–9 Package insert revisions
  • 10–99 Related PMDA documents
  • None Safety communications
  • No PMDA review report published
  • No Risk management plan (RMP)

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About PMDA approved drugs and package inserts (Japan)

Japan's PMDA publishes the package insert (添付文書) of every prescription drug, OTC drug and regenerative medical product, with brand and nonproprietary names, YJ codes and approval numbers. Names appear in Japanese as published.

Source: Pharmaceuticals and Medical Devices Agency (PMDA), Japan, package insert database · Source date:

Browse all PMDA approved drugs and package inserts (Japan)