PMDA drug package insert
スパイクバックス筋注シリンジ6ヵ月～11歳用
PMDA Prescription drug · モデルナ・ジャパン株式会社 · package insert Sep 1, 2026
Key facts
| Brand names | スパイクバックス筋注シリンジ6ヵ月～11歳用 |
|---|---|
| Nonproprietary names | コロナウイルス（ＳＡＲＳ－ＣｏＶ－２）ＲＮＡワクチン |
| Companies | 製造販売元（輸入）／モデルナ・ジャパン株式会社, プロモーション提携／田辺ファーマ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | ウイルスワクチン類 |
| Therapeutic category codes | 876313 |
| YJ codes | 631341EG2029 |
| Approval numbers | 30700AMX00092 |
| Package insert edition | 第1版 |
| Package insert date | Sep 1, 2026 |
| PMDA document key | 790314_631341EG2029_1 |
| PMDA company code | 790314 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- None Safety communications
- No PMDA review report published
- Yes 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: