PMDA drug package insert
ラフェンタテープ1.38mg
PMDA Prescription drug · 日本臓器製薬株式会社 · package insert Dec 23, 2024
Key facts
| Brand names | ラフェンタテープ1.38mg, ラフェンタテープ2.75mg, ラフェンタテープ5.5mg, ラフェンタテープ8.25mg, ラフェンタテープ11mg |
|---|---|
| Nonproprietary names | フェンタニル |
| Companies | 製造販売元／日本臓器製薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 3日用安定放出型がん疼痛治療 |
| Therapeutic category codes | 878219 |
| YJ codes | 8219700T6028, 8219700T7024, 8219700T8020, 8219700T9027, 8219700U1021 |
| Approval numbers | 23100AMX00280000, 23100AMX00281000, 23100AMX00282000, 23100AMX00283000, 23100AMX00284000 |
| Package insert edition | 第2版 |
| Package insert date | Dec 23, 2024 |
| PMDA document key | 530288_8219700T6028_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: