PMDA drug package insert
シンメトレル錠50mg
PMDA Prescription drug · サンファーマ株式会社 · package insert Jul 1, 2025
Key facts
| Brand names | シンメトレル錠50mg, シンメトレル錠100mg |
|---|---|
| Nonproprietary names | アマンタジン塩酸塩 |
| Companies | 製造販売元／サンファーマ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 精神活動改善剤; パーキンソン症候群治療剤; 抗A型インフルエンザウイルス剤 |
| Therapeutic category codes | 87117, 871161, 87625 |
| YJ codes | 1161001F1050, 1161001F2057 |
| Approval numbers | 15400AMZ00298000, 15400AMZ00299000 |
| Package insert edition | 第3版 |
| Package insert date | Jul 1, 2025 |
| PMDA document key | 480866_1161001F1050_1 |
| PMDA company code | 480866 |
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: