PMDA drug package insert
クラリスロマイシン錠50mg小児用「サワイ」
PMDA Prescription drug · 沢井製薬株式会社 · package insert Mar 17, 2026
Key facts
| Brand names | クラリスロマイシン錠50mg小児用「サワイ」, クラリスロマイシンDS10％小児用「サワイ」 |
|---|---|
| Nonproprietary names | クラリスロマイシン |
| Companies | 製造販売元／沢井製薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | マクロライド系抗生物質製剤 |
| Therapeutic category codes | 876149 |
| YJ codes | 6149003F1090, 6149003R1054 |
| Approval numbers | 21800AMZ10200000, 21800AMZ10199000 |
| Package insert edition | 第3版 |
| Package insert date | Mar 17, 2026 |
| PMDA document key | 300119_6149003F1090_1 |
| PMDA company code | 300119 |
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: