PMDA drug package insert
ソマチュリン皮下注60mg
PMDA Prescription drug · 帝人ファーマ株式会社 · package insert Dec 25, 2020
Key facts
| Brand names | ソマチュリン皮下注60mg, ソマチュリン皮下注90mg, ソマチュリン皮下注120mg |
|---|---|
| Nonproprietary names | ランレオチド酢酸塩 |
| Companies | 製造販売元（輸入元）／帝人ファーマ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 持続性ソマトスタチンアナログ徐放性製剤 |
| Therapeutic category codes | 872499 |
| YJ codes | 2499413G1025, 2499413G2021, 2499413G3028 |
| Approval numbers | 22400AMX00734000, 22400AMX00735000, 22400AMX00736000 |
| Package insert edition | 第2版、効能変更 |
| Package insert date | Dec 25, 2020 |
| PMDA document key | 470310_2499413G1025_1 |
| PMDA company code | 470310 |
At a glance
- 1–9 Package insert revisions
- 10–99 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: