PMDA drug package insert
ミケルナ配合点眼液
PMDA Prescription drug · 大塚製薬株式会社 · package insert Jan 11, 2024
Key facts
| Brand names | ミケルナ配合点眼液 |
|---|---|
| Nonproprietary names | カルテオロール塩酸塩・ラタノプロスト |
| Companies | 製造販売元／大塚製薬株式会社, 提携／千寿製薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 緑内障・高眼圧症治療剤 |
| Therapeutic category codes | 871319 |
| YJ codes | 1319823Q1026 |
| Approval numbers | 22800AMX00683 |
| Package insert edition | 第2版 |
| Package insert date | Jan 11, 2024 |
| PMDA document key | 180078_1319823Q1026_1 |
| PMDA company code | 180078 |
At a glance
- 1–9 Package insert revisions
- 1–9 Related PMDA documents
- None Safety communications
- Yes 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: