PMDA drug package insert
タベジール錠1mg
PMDA Prescription drug · 日新製薬株式会社 · package insert Jul 24, 2023
Key facts
| Brand names | タベジール錠1mg, タベジール散0.1%, タベジール散1% |
|---|---|
| Nonproprietary names | クレマスチンフマル酸塩 |
| Companies | 製造販売元／日新製薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 持続性抗ヒスタミン剤 |
| Therapeutic category codes | 874419 |
| YJ codes | 4419008F1431, 4419008B1073, 4419008B2070 |
| Approval numbers | 22000AMX01633, 22000AMX01635, 22000AMX01634 |
| Package insert edition | 第1版 |
| Package insert date | Jul 24, 2023 |
| PMDA document key | 530113_4419008B1073_3 |
| PMDA company code | 530113 |
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: