PMDA drug package insert
イベニティ皮下注105mgシリンジ
PMDA Prescription drug · アムジェン株式会社 · package insert Jul 15, 2026
Key facts
| Brand names | イベニティ皮下注105mgシリンジ |
|---|---|
| Nonproprietary names | ロモソズマブ（遺伝子組換え） |
| Companies | 製造販売元／アムジェン株式会社, 販売元／アステラス製薬株式会社, 提携先／ユーシービージャパン株式会社 |
| Product type | Prescription drug |
| Therapeutic category | ヒト化抗スクレロスチンモノクローナル抗体製剤 |
| Therapeutic category codes | 873999 |
| YJ codes | 3999449G1025 |
| Approval numbers | 23100AMX00004000 |
| Package insert edition | 第2版 |
| Package insert date | Jul 15, 2026 |
| PMDA document key | 112292_3999449G1025_2 |
| PMDA company code | 112292 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- 1–9 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: