PMDA drug package insert
バルプロ酸ナトリウムSR錠100mg「アメル」
PMDA Prescription drug · 共和薬品工業株式会社 · package insert Mar 17, 2026
Key facts
| Brand names | バルプロ酸ナトリウムSR錠100mg「アメル」, バルプロ酸ナトリウムSR錠200mg「アメル」 |
|---|---|
| Nonproprietary names | バルプロ酸ナトリウム |
| 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、躁病・躁状態治療剤、片頭痛治療剤 |
| Therapeutic category codes | 871139, 871179 |
| YJ codes | 1139004G1067, 1139004G2055 |
| Approval numbers | 22500AMX01526, 21800AMZ10075 |
| Package insert edition | 第6版 |
| Package insert date | Mar 17, 2026 |
| PMDA document key | 672173_1139004G1067_2 |
| PMDA company code | 672173 |
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: