PMDA drug package insert
ロセフィン静注用0.5g
PMDA Prescription drug · 太陽ファルマ株式会社 · package insert Jun 16, 2026
Key facts
| Brand names | ロセフィン静注用0.5g, ロセフィン静注用1g, ロセフィン点滴静注用1gバッグ |
|---|---|
| Nonproprietary names | セフトリアキソンナトリウム水和物 |
| Companies | 製造販売元／太陽ファルマ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | セフェム系抗生物質製剤 |
| Therapeutic category codes | 876132 |
| YJ codes | 6132419F1020, 6132419F2026, 6132419G1025 |
| Approval numbers | 16100MZY00307, 16100MZY00308, 21500AMZ00170 |
| Package insert edition | 第2版 |
| Package insert date | Jun 16, 2026 |
| PMDA document key | 431010_6132419F1020_3 |
| PMDA company code | 431010 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- None Safety communications
- Yes 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: