PMDA drug package insert

ラコサミド錠50mg「ダイト」

PMDA Prescription drug · ダイト株式会社 · package insert Apr 10, 2026

Key facts

Brand names ラコサミド錠50mg「ダイト」, ラコサミド錠100mg「ダイト」
Nonproprietary names ラコサミド
Companies 製造販売元/ダイト株式会社, 販売元/株式会社フェルゼンファーマ
Product type Prescription drug
Therapeutic category 抗てんかん剤
Therapeutic category codes 871139
YJ codes 1139015F1108, 1139015F2104
Approval numbers 30700AMX00169000, 30700AMX00170000
Package insert edition 第4版
Package insert date Apr 10, 2026
PMDA document key 400073_1139015F1108_1
PMDA company code 400073

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)