PMDA drug package insert
ネオビタカイン注シリンジ2mL
PMDA Prescription drug · ビタカイン製薬株式会社 · package insert Dec 1, 2025
Key facts
| Brand names | ネオビタカイン注シリンジ2mL, ネオビタカイン注シリンジ5mL |
|---|---|
| Nonproprietary names | サリチル酸ナトリウム・ジブカイン配合剤 |
| Companies | 製造販売元／ビタカイン製薬株式会社, 販売／田辺ファーマ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 疼痛治療剤（局所注射用） |
| Therapeutic category codes | 871143 |
| YJ codes | 1149502G1022, 1149503G1027 |
| Approval numbers | 21600AMZ00443, 21600AMZ00444 |
| Package insert edition | 第3版 |
| Package insert date | Dec 1, 2025 |
| PMDA document key | 650047_1149502G1022_1 |
| PMDA company code | 650047 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- 1–9 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: