PMDA drug package insert
メイロン静注8.4%(20mLアンプル)
PMDA Prescription drug · 株式会社大塚製薬工場 · package insert Aug 25, 2023
Key facts
| Brand names | メイロン静注8.4%(20mLアンプル), メイロン静注8.4%(250mLバッグ) |
|---|---|
| Nonproprietary names | 炭酸水素ナトリウム |
| 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 | 炭酸水素ナトリウム注射液 |
| Therapeutic category codes | 873929 |
| YJ codes | 3929400A7063, 3929400H3031 |
| Approval numbers | 22000AMX00126 |
| Package insert edition | 第1版 |
| Package insert date | Aug 25, 2023 |
| PMDA document key | 180079_3929400A7063_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: