PMDA drug package insert
クラリチンドライシロップ1%
PMDA Prescription drug · バイエル薬品株式会社 · package insert Oct 8, 2021
Key facts
| Brand names | クラリチンドライシロップ1% |
|---|---|
| Nonproprietary names | ロラタジン |
| Companies | 製造販売元／バイエル薬品株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 持続性選択H1受容体拮抗・アレルギー性疾患治療剤 |
| Therapeutic category codes | 87449 |
| YJ codes | 4490027R1029 |
| Approval numbers | 21900AMZ00081000 |
| Package insert edition | 第1版 |
| Package insert date | Oct 8, 2021 |
| PMDA document key | 630004_4490027R1029_3 |
| PMDA company code | 630004 |
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: