PMDA drug package insert
ビオチン・ドライシロップ0.1%「ホエイ」
PMDA Prescription drug · 東洋製薬化成株式会社 · package insert Oct 22, 2025
Key facts
| Brand names | ビオチン・ドライシロップ0.1%「ホエイ」, ビオチン散0.2%「ホエイ」 |
|---|---|
| Nonproprietary names | ビオチン |
| Companies | 製造販売元／東洋製薬化成株式会社, 販売元／ヴィアトリス製薬合同会社 |
| Product type | Prescription drug |
| Therapeutic category | 抗皮膚炎ビタミン剤 |
| Therapeutic category codes | 87319 |
| YJ codes | 3190001R1031, 3190001B1050 |
| Approval numbers | 21900AMX01403, 21900AMX01402 |
| Package insert edition | 第4版 |
| Package insert date | Oct 22, 2025 |
| PMDA document key | 480199_3190001B1050_1 |
| PMDA company code | 480199 |
At a glance
- 1–9 Package insert revisions
- 1–9 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: