PMDA drug package insert
ダラザレックス点滴静注100mg
PMDA Prescription drug · ヤンセンファーマ株式会社 · package insert Jun 27, 2025
Key facts
| Brand names | ダラザレックス点滴静注100mg, ダラザレックス点滴静注400mg |
|---|---|
| Nonproprietary names | ダラツムマブ（遺伝子組換え） |
| Companies | 製造販売元（輸入）／ヤンセンファーマ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | ヒト型抗CD38モノクローナル抗体 |
| Therapeutic category codes | 874291 |
| YJ codes | 4291437A1028, 4291437A2024 |
| Approval numbers | 22900AMX00983000, 22900AMX00984000 |
| Package insert edition | 第6版 |
| Package insert date | Jun 27, 2025 |
| PMDA document key | 800155_4291437A1028_1 |
| PMDA company code | 800155 |
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: