PMDA drug package insert
ケトチフェン点眼液0.05%「ニッテン」
PMDA Prescription drug · ロートニッテンファーマ株式会社 · package insert Apr 11, 2025
Key facts
| Brand names | ケトチフェン点眼液0.05%「ニッテン」 |
|---|---|
| Nonproprietary names | ケトチフェンフマル酸塩 |
| Companies | 製造販売元／ロートニッテンファーマ株式会社, 販売元／ロートニッテン株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 抗アレルギー点眼剤 |
| Therapeutic category codes | 871319 |
| YJ codes | 1319730Q1389 |
| Approval numbers | 23000AMX00897000 |
| Package insert edition | 第1版 |
| Package insert date | Apr 11, 2025 |
| PMDA document key | 531077_1319730Q1389_1 |
| PMDA company code | 531077 |
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: