PMDA drug package insert
酢酸亜鉛錠25mg「ノーベル」
PMDA Prescription drug · ダイト株式会社 · package insert Mar 19, 2026
Key facts
| Brand names | 酢酸亜鉛錠25mg「ノーベル」, 酢酸亜鉛錠50mg「ノーベル」, 酢酸亜鉛顆粒5%「ノーベル」 |
|---|---|
| Nonproprietary names | 酢酸亜鉛水和物 |
| Companies | 製造販売元/ダイト株式会社, 販売提携/ノーベルファーマ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | ウィルソン病治療剤(銅吸収阻害剤); 低亜鉛血症治療剤 |
| Therapeutic category codes | 873929 |
| YJ codes | 3929007F1045, 3929007F2041, 3929007D1044 |
| Approval numbers | 30500AMX00211000, 30500AMX00212000, 30600AMX00049000 |
| Package insert edition | 第6版 |
| Package insert date | Mar 19, 2026 |
| PMDA document key | 400073_3929007F1045_1 |
| PMDA company code | 400073 |
At a glance
- 1–9 Package insert revisions
- 10–99 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: