PMDA drug package insert
ラモトリギン錠小児用2mg「アメル」
PMDA Prescription drug · 共和薬品工業株式会社 · package insert Aug 27, 2026
Key facts
| Brand names | ラモトリギン錠小児用2mg「アメル」, ラモトリギン錠小児用5mg「アメル」, ラモトリギン錠25mg「アメル」, ラモトリギン錠100mg「アメル」 |
|---|---|
| Nonproprietary names | ラモトリギン |
| Companies | 製造販売元／共和薬品工業株式会社 |
| 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 | 1139009F1072, 1139009F2079, 1139009F3040, 1139009F4047 |
| Approval numbers | 30300AMX00043, 30300AMX00044, 23000AMX00328, 23000AMX00329 |
| Package insert edition | 第5版 |
| Package insert date | Aug 27, 2026 |
| PMDA document key | 672173_1139009F1072_2 |
| PMDA company code | 672173 |
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: