PMDA drug package insert
オロパタジン塩酸塩OD錠2.5mg「フェルゼン」
PMDA Prescription drug · 株式会社フェルゼンファーマ · package insert Nov 30, 2023
Key facts
| Brand names | オロパタジン塩酸塩OD錠2.5mg「フェルゼン」, オロパタジン塩酸塩OD錠5mg「フェルゼン」 |
|---|---|
| Nonproprietary names | オロパタジン塩酸塩 |
| Companies | 製造販売元／株式会社フェルゼンファーマ |
| Product type | Prescription drug |
| Therapeutic category | アレルギー性疾患治療剤 |
| Therapeutic category codes | 87449 |
| YJ codes | 4490025F3174, 4490025F4170 |
| Approval numbers | 23000AMX00323000, 23000AMX00324000 |
| Package insert edition | 第1版 |
| Package insert date | Nov 30, 2023 |
| PMDA document key | 671940_4490025F3174_1 |
| PMDA company code | 671940 |
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: