PMDA drug package insert
メキシチールカプセル50mg
PMDA Prescription drug · 太陽ファルマ株式会社 · package insert Feb 25, 2025
Key facts
| Brand names | メキシチールカプセル50mg, メキシチールカプセル100mg |
|---|---|
| Nonproprietary names | メキシレチン塩酸塩 |
| Companies | 製造販売元／太陽ファルマ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 不整脈治療剤・糖尿病性神経障害治療剤 |
| Therapeutic category codes | 872129, 87190 |
| YJ codes | 2129003M1021, 2129003M2028 |
| Approval numbers | 16000AMY00029, 16000AMY00030 |
| Package insert edition | 第3版 |
| Package insert date | Feb 25, 2025 |
| PMDA document key | 431010_2129003M1021_2 |
| PMDA company code | 431010 |
At a glance
- 1–9 Package insert revisions
- 10–99 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: