PMDA drug package insert
生食注シリンジ「オーツカ」5mL
PMDA Prescription drug · 株式会社大塚製薬工場 · package insert Sep 30, 2025
Key facts
| Brand names | 生食注シリンジ「オーツカ」5mL, 生食注シリンジ「オーツカ」10mL, 生食注シリンジ「オーツカ」20mL |
|---|---|
| Nonproprietary names | 生理食塩液 |
| Companies | 製造販売元／株式会社大塚製薬工場, 販売提携／大塚製薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 生理食塩液 |
| Therapeutic category codes | 873311 |
| YJ codes | 3311402P2040, 3311402G7050, 3311402G8056 |
| Approval numbers | 21800AMZ10039, 22000AMX01743, 22000AMX01744 |
| Package insert edition | 第2版 |
| Package insert date | Sep 30, 2025 |
| PMDA document key | 180079_3311402G7050_1 |
| PMDA company code | 180079 |
At a glance
- 1–9 Package insert revisions
- 1–9 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: