PMDA drug package insert
モノヴァー静注500mg
PMDA Prescription drug · 日本新薬株式会社 · package insert Mar 15, 2023
Key facts
| Brand names | モノヴァー静注500mg, モノヴァー静注1000mg |
|---|---|
| Nonproprietary names | デルイソマルトース第二鉄 |
| Companies | 製造販売元／日本新薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 鉄欠乏性貧血治療剤 |
| Therapeutic category codes | 873222 |
| YJ codes | 3222405A1026, 3222405A2022 |
| Approval numbers | 30400AMX00183000, 30400AMX00184000 |
| Package insert edition | 第1版 |
| Package insert date | Mar 15, 2023 |
| PMDA document key | 530263_3222405A1026_1 |
| PMDA company code | 530263 |
At a glance
- 1–9 Package insert revisions
- 1–9 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: