PMDA drug package insert
マイロターグ点滴静注用5mg
PMDA Prescription drug · ファイザー株式会社 · package insert Mar 28, 2022
Key facts
| Brand names | マイロターグ点滴静注用5mg |
|---|---|
| Nonproprietary names | ゲムツズマブオゾガマイシン（遺伝子組換え） |
| Companies | 製造販売元／ファイザー株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 抗悪性腫瘍剤; 抗腫瘍性抗生物質結合抗CD33モノクローナル抗体 |
| Therapeutic category codes | 874239 |
| YJ codes | 4239400D1030 |
| Approval numbers | 22000AMX00004 |
| Package insert edition | 第2版 |
| Package insert date | Mar 28, 2022 |
| PMDA document key | 672212_4239400D1030_3 |
| PMDA company code | 672212 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- None Safety communications
- Yes PMDA review report published
- No 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: