PMDA drug package insert
ロメフロン耳科用液0.3％
PMDA Prescription drug · 千寿製薬株式会社 · package insert Nov 2, 2020
Key facts
| Brand names | ロメフロン耳科用液0.3％ |
|---|---|
| Nonproprietary names | 塩酸ロメフロキサシン |
| Companies | 製造販売元／千寿製薬株式会社, 発売元／セオリアファーマ株式会社, 販売／武田薬品工業株式会社 |
| Product type | Prescription drug |
| Therapeutic category | ニューキノロン系抗菌耳科用液 |
| Therapeutic category codes | 871329 |
| YJ codes | 1329709Q1032 |
| Approval numbers | 21900AMX01417 |
| Package insert edition | 第2版 |
| Package insert date | Nov 2, 2020 |
| PMDA document key | 380086_1329709Q1032_1 |
| PMDA company code | 380086 |
At a glance
- 1–9 Package insert revisions
- 1–9 Related PMDA documents
- None Safety communications
- No 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: