PMDA drug package insert
ドルモロール配合点眼液「ニットー」
PMDA Prescription drug · 東亜薬品株式会社 · package insert Jul 24, 2023
Key facts
| Brand names | ドルモロール配合点眼液「ニットー」 |
|---|---|
| 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／東亜薬品株式会社, 発売元／日東メディック株式会社 |
| 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 | 1319819Q1046 |
| Approval numbers | 23000AMX00307000 |
| Package insert edition | 第1版 |
| Package insert date | Jul 24, 2023 |
| PMDA document key | 480018_1319819Q1046_1 |
| PMDA company code | 480018 |
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: