PMDA drug package insert
塩化ナトリウム「オーツカ」
PMDA Prescription drug · 株式会社大塚製薬工場 · package insert Jan 19, 2024
Key facts
| Brand names | 塩化ナトリウム「オーツカ」 |
|---|---|
| Nonproprietary names | 塩化ナトリウム |
| 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 codes | 877190 |
| YJ codes | 7190701X1036 |
| Approval numbers | 16000AMZ00537 |
| Package insert edition | 第1版 |
| Package insert date | Jan 19, 2024 |
| PMDA document key | 180079_7190701X1036_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: