PMDA drug package insert
メマンチン塩酸塩OD錠5mg「フェルゼン」
PMDA Prescription drug · ダイト株式会社 · package insert Dec 25, 2023
Key facts
| Brand names | メマンチン塩酸塩OD錠5mg「フェルゼン」, メマンチン塩酸塩OD錠10mg「フェルゼン」, メマンチン塩酸塩OD錠20mg「フェルゼン」 |
|---|---|
| Nonproprietary names | メマンチン塩酸塩 |
| 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 | NMDA受容体拮抗 アルツハイマー型認知症治療剤 |
| Therapeutic category codes | 87119 |
| YJ codes | 1190018F4235, 1190018F5231, 1190018F6238 |
| Approval numbers | 30200AMX00085000, 30200AMX00086000, 30200AMX00088000 |
| Package insert edition | 第1版 |
| Package insert date | Dec 25, 2023 |
| PMDA document key | 400073_1190018F4235_1 |
| PMDA company code | 400073 |
At a glance
- 1–9 Package insert revisions
- 10–99 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: