PMDA drug package insert
オロパタジン塩酸塩ODフィルム2.5mg「マルホ」
PMDA Prescription drug · 救急薬品工業株式会社 · package insert Sep 29, 2023
Key facts
| Brand names | オロパタジン塩酸塩ODフィルム2.5mg「マルホ」, オロパタジン塩酸塩ODフィルム5mg「マルホ」 |
|---|---|
| Nonproprietary names | オロパタジン塩酸塩 |
| Companies | 製造販売元／救急薬品工業株式会社, 販売／マルホ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | アレルギー性疾患治療剤 |
| Therapeutic category codes | 87449 |
| YJ codes | 4490025F3085, 4490025F4081 |
| Approval numbers | 22400AMX00998000, 22400AMX00999000 |
| Package insert edition | 第1版 |
| Package insert date | Sep 29, 2023 |
| PMDA document key | 230064_4490025F3085_1 |
| PMDA company code | 230064 |
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: