PMDA drug package insert
アマンタジン塩酸塩錠50mg「サワイ」
PMDA Prescription drug · 沢井製薬株式会社 · package insert Aug 29, 2025
Key facts
| Brand names | アマンタジン塩酸塩錠50mg「サワイ」, アマンタジン塩酸塩錠100mg「サワイ」, アマンタジン塩酸塩細粒10％「サワイ」 |
|---|---|
| Nonproprietary names | アマンタジン塩酸塩 |
| Companies | 製造販売元／沢井製薬株式会社 |
| 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 | 871161, 87117, 87625 |
| YJ codes | 1161001F1131, 1161001F2154, 1161001C1135 |
| Approval numbers | 22400AMX00934000, 22400AMX00935000, 22400AMX00933000 |
| Package insert edition | 第2版 |
| Package insert date | Aug 29, 2025 |
| PMDA document key | 300119_1161001C1135_1 |
| PMDA company code | 300119 |
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: