PMDA drug package insert
テモカプリル塩酸塩錠1mg「フェルゼン」
PMDA Prescription drug · ダイト株式会社 · package insert Sep 11, 2025
Key facts
| Brand names | テモカプリル塩酸塩錠1mg「フェルゼン」, テモカプリル塩酸塩錠2mg「フェルゼン」, テモカプリル塩酸塩錠4mg「フェルゼン」 |
|---|---|
| Nonproprietary names | テモカプリル塩酸塩 |
| Companies | 製造販売元／ダイト株式会社, 販売元／株式会社フェルゼンファーマ |
| Product type | Prescription drug |
| Therapeutic category | 胆汁・腎排泄型ACE阻害剤 |
| Therapeutic category codes | 872144 |
| YJ codes | 2144009F1182, 2144009F2189, 2144009F3185 |
| Approval numbers | 30400AMX00216000, 30400AMX00217000, 30400AMX00218000 |
| Package insert edition | 第2版 |
| Package insert date | Sep 11, 2025 |
| PMDA document key | 400073_2144009F1182_1 |
| PMDA company code | 400073 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- 1–9 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: