PMDA drug package insert
プレセデックス静注液200μg「ファイザー」
PMDA Prescription drug · ファイザー株式会社 · package insert Aug 25, 2026
Key facts
| Brand names | プレセデックス静注液200μg「ファイザー」, プレセデックス静注液200μg/50mLシリンジ「ファイザー」 |
|---|---|
| Nonproprietary names | デクスメデトミジン塩酸塩 |
| Companies | 製造販売元／ファイザー株式会社 |
| Product type | Prescription drug |
| Therapeutic category | α2作動性鎮静剤 |
| Therapeutic category codes | 871129 |
| YJ codes | 1129400A1054, 1129400G1022 |
| Approval numbers | 21600AMY00007, 23000AMX00469 |
| Package insert edition | 第3版 |
| Package insert date | Aug 25, 2026 |
| PMDA document key | 672212_1129400A1054_2 |
| PMDA company code | 672212 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- None Safety communications
- Yes 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: