PMDA drug package insert
ツートラム錠25mg
PMDA Prescription drug · 日本臓器製薬株式会社 · package insert May 13, 2024
Key facts
| Brand names | ツートラム錠25mg, ツートラム錠50mg, ツートラム錠100mg, ツートラム錠150mg |
|---|---|
| Nonproprietary names | トラマドール塩酸塩 |
| Companies | 製造販売元／日本臓器製薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 慢性疼痛・がん疼痛 持続性鎮痛剤 |
| Therapeutic category codes | 871149 |
| YJ codes | 1149038G5025, 1149038G2026, 1149038G3022, 1149038G4029 |
| Approval numbers | 30400AMX00349000, 30200AMX00944000, 30200AMX00945000, 30200AMX00946000 |
| Package insert edition | 第7版 |
| Package insert date | May 13, 2024 |
| PMDA document key | 530288_1149038G2026_1 |
| PMDA company code | 530288 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- None Safety communications
- Yes 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: