PMDA drug package insert
ノルスパンテープ5mg
PMDA Prescription drug · ムンディファーマ株式会社 · package insert Oct 18, 2023
Key facts
| Brand names | ノルスパンテープ5mg, ノルスパンテープ10mg, ノルスパンテープ20mg |
|---|---|
| Nonproprietary names | ブプレノルフィン |
| Companies | 製造販売元／ムンディファーマ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 経皮吸収型 持続性疼痛治療剤 |
| Therapeutic category codes | 871149 |
| YJ codes | 1149704S1020, 1149704S2027, 1149704S3023 |
| Approval numbers | 22300AMX00480000, 22300AMX00481000, 22300AMX00482000 |
| Package insert edition | 第1版 |
| Package insert date | Oct 18, 2023 |
| PMDA document key | 770098_1149704S1020_1 |
| PMDA company code | 770098 |
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: