PMDA drug package insert

ラモトリギン錠小児用2mg「JG」

PMDA Prescription drug · 日本ジェネリック株式会社 · package insert Aug 27, 2026

Key facts

Brand names ラモトリギン錠小児用2mg「JG」, ラモトリギン錠小児用5mg「JG」, ラモトリギン錠25mg「JG」, ラモトリギン錠100mg「JG」
Nonproprietary names ラモトリギン
Companies 製造販売元/日本ジェネリック株式会社
Product type Prescription drug
Therapeutic category 抗てんかん剤; 抗てんかん剤、双極性障害治療薬
Therapeutic category codes 871139, 871179
YJ codes 1139009F1064, 1139009F2060, 1139009F3032, 1139009F4039
Approval numbers 30300AMX00041000, 30300AMX00042000, 23000AMX00330000, 23000AMX00331000
Package insert edition 第6版
Package insert date Aug 27, 2026
PMDA document key 580591_1139009F1064_1
PMDA company code 580591

At a glance

  • 1–9 Package insert revisions
  • 10–99 Related PMDA documents
  • 1–9 Safety communications
  • No PMDA review report published
  • Yes 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)