PMDA drug package insert
クラバモックス小児用配合ドライシロップ
PMDA Prescription drug · グラクソ・スミスクライン株式会社 · package insert Oct 8, 2024
Key facts
| Brand names | クラバモックス小児用配合ドライシロップ |
|---|---|
| Nonproprietary names | アモキシシリン水和物・クラブラン酸カリウム |
| Companies | 製造販売元/グラクソ・スミスクライン株式会社 |
| Product type | Prescription drug |
| Therapeutic category | β-ラクタマーゼ阻害剤配合ペニシリン系抗生物質製剤 |
| Therapeutic category codes | 876139 |
| YJ codes | 6139100R1036 |
| Approval numbers | 22100AMX01039 |
| Package insert edition | 第4版 |
| Package insert date | Oct 8, 2024 |
| PMDA document key | 340278_6139100R1036_1 |
| PMDA company code | 340278 |
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: