PMDA drug package insert
フィニバックス点滴静注用0.25g
PMDA Prescription drug · 塩野義製薬株式会社 · package insert Sep 15, 2023
Key facts
| Brand names | フィニバックス点滴静注用0.25g, フィニバックス点滴静注用0.5g, フィニバックスキット点滴静注用0.25g |
|---|---|
| Nonproprietary names | ドリペネム水和物 |
| Companies | 製造販売元／塩野義製薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | カルバペネム系抗生物質製剤 |
| Therapeutic category codes | 876139 |
| YJ codes | 6139402D1032, 6139402D2020, 6139402G1039 |
| Approval numbers | 22300AMX00576000, 22300AMX00625000, 22300AMX00577000 |
| Package insert edition | 第1版 |
| Package insert date | Sep 15, 2023 |
| PMDA document key | 340018_6139402D1032_1 |
| PMDA company code | 340018 |
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: