PMDA drug package insert
ビンゼレックス皮下注160mgシリンジ
PMDA Prescription drug · ユーシービージャパン株式会社 · package insert May 29, 2025
Key facts
| Brand names | ビンゼレックス皮下注160mgシリンジ, ビンゼレックス皮下注160mgオートインジェクター, ビンゼレックス皮下注320mgオートインジェクター |
|---|---|
| Nonproprietary names | ビメキズマブ（遺伝子組換え） |
| Companies | 製造販売元／ユーシービージャパン株式会社 |
| Product type | Prescription drug |
| Therapeutic category | ヒト化抗ヒトIL-17A/IL-17Fモノクローナル抗体製剤 |
| Therapeutic category codes | 873999 |
| YJ codes | 3999464G1020, 3999464G2026, 3999464G3022 |
| Approval numbers | 30400AMX00010000, 30400AMX00011000, 30700AMX00013000 |
| Package insert edition | 第7版 |
| Package insert date | May 29, 2025 |
| PMDA document key | 820110_3999464G1020_1 |
| PMDA company code | 820110 |
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: