PMDA drug package insert

ラコサミド錠50mg「ケミファ」

PMDA Prescription drug · 日本ケミファ株式会社 · package insert Sep 15, 2026

Key facts

Brand names ラコサミド錠50mg「ケミファ」, ラコサミド錠100mg「ケミファ」
Nonproprietary names ラコサミド
Companies 製造販売元/日本ケミファ株式会社, 販売元/共創未来ファーマ株式会社
Product type Prescription drug
Therapeutic category 抗てんかん剤
Therapeutic category codes 871139
YJ codes 1139015F1078, 1139015F2074
Approval numbers 30700AMX00172000, 30700AMX00173000
Package insert edition 第5版
Package insert date Sep 15, 2026
PMDA document key 530213_1139015F1078_2
PMDA company code 530213

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)