PMDA drug package insert
ワコビタール坐剤15
PMDA Prescription drug · 高田製薬株式会社 · package insert Jun 16, 2026
Key facts
| Brand names | ワコビタール坐剤15, ワコビタール坐剤30, ワコビタール坐剤50, ワコビタール坐剤100 |
|---|---|
| Nonproprietary names | フェノバルビタールナトリウム |
| Companies | 製造販売元／高田製薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 小児用催眠・鎮静・抗けいれん剤 |
| Therapeutic category codes | 871125 |
| YJ codes | 1125700J1025, 1125700J3028, 1125700J4032, 1125700J5039 |
| Approval numbers | 15500AMZ00201, 15500AMZ00202, 15500AMZ00203, 15500AMZ00204 |
| Package insert edition | 第3版 |
| Package insert date | Jun 16, 2026 |
| PMDA document key | 400186_1125700J1025_2 |
| PMDA company code | 400186 |
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: