PMDA drug package insert
ドルモロール配合点眼液「日点」
PMDA Prescription drug · ロートニッテン株式会社 · package insert May 16, 2025
Key facts
| Brand names | ドルモロール配合点眼液「日点」 |
|---|---|
| Nonproprietary names | ドルゾラミド塩酸塩・チモロールマレイン酸塩 |
| Companies | 製造販売元／ロートニッテン株式会社, 販売元／株式会社フェルゼンファーマ |
| Product type | Prescription drug |
| Therapeutic category | 炭酸脱水酵素阻害剤／β-遮断剤配合剤; 緑内障・高眼圧症治療剤 |
| Therapeutic category codes | 871319 |
| YJ codes | 1319819Q1062 |
| Approval numbers | 23000AMX00786000 |
| Package insert edition | 第2版 |
| Package insert date | May 16, 2025 |
| PMDA document key | 530304_1319819Q1062_3 |
| PMDA company code | 530304 |
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: