PMDA drug package insert
ベタヒスチンメシル酸塩錠6mg「CEO」
PMDA Prescription drug · セオリアファーマ株式会社 · package insert Nov 29, 2023
Key facts
| Brand names | ベタヒスチンメシル酸塩錠6mg「CEO」, ベタヒスチンメシル酸塩錠12mg「CEO」 |
|---|---|
| Nonproprietary names | ベタヒスチンメシル酸塩 |
| Companies | 製造販売元／セオリアファーマ株式会社, 販売／武田薬品工業株式会社 |
| Product type | Prescription drug |
| Therapeutic category | めまい・平衡障害治療剤 |
| Therapeutic category codes | 871339 |
| YJ codes | 1339005F1431, 1339005F2217 |
| Approval numbers | 22500AMX00147, 22500AMX00148 |
| Package insert edition | 第1版 |
| Package insert date | Nov 29, 2023 |
| PMDA document key | 380999_1339005F1431_1 |
| PMDA company code | 380999 |
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: