PMDA drug package insert
ロタリックス内用液
PMDA Prescription drug · グラクソ・スミスクライン株式会社 · package insert Dec 23, 2025
Key facts
| Brand names | ロタリックス内用液 |
|---|---|
| Nonproprietary names | 経口弱毒生ヒトロタウイルスワクチン |
| 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 | ウイルスワクチン類 |
| Therapeutic category codes | 876313 |
| YJ codes | 631300AS1020 |
| Approval numbers | 22300AMX00591 |
| Package insert edition | 第3版 |
| Package insert date | Dec 23, 2025 |
| PMDA document key | 340278_631300AS1020_3 |
| 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: