PMDA drug package insert
レブコビ筋注2.4mg
PMDA Prescription drug · 帝人ファーマ株式会社 · package insert May 9, 2022
Key facts
| Brand names | レブコビ筋注2.4mg |
|---|---|
| Nonproprietary names | エラペグアデマーゼ（遺伝子組換え） |
| Companies | 製造販売元／帝人ファーマ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | ポリエチレングリコール修飾遺伝子組換えアデノシンデアミナーゼ酵素製剤 |
| Therapeutic category codes | 873959 |
| YJ codes | 3959421A1023 |
| Approval numbers | 23100AMX00293000 |
| Package insert edition | 第1版 |
| Package insert date | May 9, 2022 |
| PMDA document key | 470310_3959421A1023_1 |
| PMDA company code | 470310 |
At a glance
- 1–9 Package insert revisions
- 1–9 Related PMDA documents
- None Safety communications
- Yes PMDA review report published
- Yes 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: