PMDA drug package insert
トラマールOD錠25mg
PMDA Prescription drug · 日本新薬株式会社 · package insert Jun 11, 2024
Key facts
| Brand names | トラマールOD錠25mg, トラマールOD錠50mg |
|---|---|
| Nonproprietary names | トラマドール塩酸塩 |
| Companies | 製造販売元／日本新薬株式会社, 提携／Grünenthal GmbH |
| Product type | Prescription drug |
| Therapeutic category | がん疼痛・慢性疼痛治療剤 |
| Therapeutic category codes | 871149 |
| YJ codes | 1149038F1024, 1149038F2020 |
| Approval numbers | 22600AMX01295000, 22600AMX01296000 |
| Package insert edition | 第3版 |
| Package insert date | Jun 11, 2024 |
| PMDA document key | 530263_1149038F1024_1 |
| PMDA company code | 530263 |
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: