PMDA drug package insert
バビースモ硝子体内注射液120mg/mL
PMDA Prescription drug · 中外製薬株式会社 · package insert May 28, 2025
Key facts
| Brand names | バビースモ硝子体内注射液120mg/mL, バビースモ硝子体内注射用キット120mg/mL |
|---|---|
| Nonproprietary names | ファリシマブ（遺伝子組換え） |
| Companies | 製造販売元／中外製薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 眼科用VEGF注1）/Ang-2注2）阻害剤; 抗VEGF/抗Ang-2ヒト化二重特異性モノクローナル抗体; 注1）VEGF：Vascular Endothelial Growth Factor 注2）Ang-2：Angiopoietin-2 |
| Therapeutic category codes | 871319 |
| YJ codes | 1319408A1020, 1319408G1023 |
| Approval numbers | 30400AMX00188, 30700AMX00059 |
| Package insert edition | 第6版 |
| Package insert date | May 28, 2025 |
| PMDA document key | 450045_1319408A1020_1 |
| PMDA company code | 450045 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- None Safety communications
- Yes PMDA review report published
- Yes 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: