PMDA drug package insert
ルセンティス硝子体内注射用キット10mg/mL
PMDA Prescription drug · ノバルティスファーマ株式会社 · package insert Aug 5, 2024
Key facts
| Brand names | ルセンティス硝子体内注射用キット10mg/mL |
|---|---|
| Nonproprietary names | ラニビズマブ（遺伝子組換え） |
| Companies | 製造販売（輸入）／ノバルティスファーマ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 眼科用VEGF阻害剤 （ヒト化抗VEGFモノクローナル抗体Fab断片）VEGF：vascular endothelial growth factor（血管内皮増殖因子） |
| Therapeutic category codes | 871319 |
| YJ codes | 1319403G1020 |
| Approval numbers | 22600AMX00564000 |
| Package insert edition | 第2版 |
| Package insert date | Aug 5, 2024 |
| PMDA document key | 300242_1319403G1020_1 |
| PMDA company code | 300242 |
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: