PMDA drug package insert

ラコサミド点滴静注100mg「日新」

PMDA Prescription drug · 日新製薬株式会社 · package insert Jun 12, 2026

Key facts

Brand names ラコサミド点滴静注100mg「日新」, ラコサミド点滴静注200mg「日新」
Nonproprietary names ラコサミド
Companies 製造販売元/日新製薬株式会社
Product type Prescription drug
Therapeutic category 抗てんかん剤
Therapeutic category codes 871139
YJ codes 1139404A3027, 1139404A4023
Approval numbers 30800AMX00048, 30800AMX00049
Package insert edition 第2版
Package insert date Jun 12, 2026
PMDA document key 530113_1139404A3027_1
PMDA company code 530113

At a glance

  • 1–9 Package insert revisions
  • 1–9 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)