PMDA drug package insert
ミラノール顆粒11%
PMDA Prescription drug · 東洋製薬化成株式会社 · package insert Oct 30, 2023
Key facts
| Brand names | ミラノール顆粒11% |
|---|---|
| Nonproprietary names | フッ化ナトリウム |
| Companies | 製造販売元／東洋製薬化成株式会社, 発売元／株式会社ビーブランド・メディコーデンタル |
| Product type | Prescription drug |
| Therapeutic category | う蝕予防フッ化物洗口剤 |
| Therapeutic category codes | 87279 |
| YJ codes | 279080BF1041 |
| Approval numbers | 21700AMZ00612 |
| Package insert edition | 第1版 |
| Package insert date | Oct 30, 2023 |
| PMDA document key | 480199_279080BF1041_1 |
| PMDA company code | 480199 |
At a glance
- 1–9 Package insert revisions
- 1–9 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: