PMDA drug package insert
インスリン グラルギンBS注キット「FFP」
PMDA Prescription drug · 富士フイルム富山化学株式会社 · package insert Jan 15, 2024
Key facts
| Brand names | インスリン グラルギンBS注キット「FFP」 |
|---|---|
| Nonproprietary names | インスリン グラルギン（遺伝子組換え） |
| Companies | 製造販売元／富士フイルム富山化学株式会社, プロモーション提携／株式会社三和化学研究所 |
| Product type | Prescription drug |
| Therapeutic category | 持効型溶解インスリンアナログ製剤 |
| Therapeutic category codes | 872492 |
| YJ codes | 2492421G1029 |
| Approval numbers | 22800AMX00369000 |
| Package insert edition | 第2版 |
| Package insert date | Jan 15, 2024 |
| PMDA document key | 400022_2492421G1029_2 |
| PMDA company code | 400022 |
At a glance
- 1–9 Package insert revisions
- 1–9 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: