PMDA drug package insert
ミチーガ皮下注用30mgバイアル
PMDA Prescription drug · マルホ株式会社 · package insert Jun 23, 2025
Key facts
| Brand names | ミチーガ皮下注用30mgバイアル |
|---|---|
| Nonproprietary names | ネモリズマブ（遺伝子組換え） |
| Companies | 製造販売／マルホ株式会社, 提携／中外製薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | ヒト化抗ヒトIL-31受容体Aモノクローナル抗体 |
| Therapeutic category codes | 87449 |
| YJ codes | 4490408D1021 |
| Approval numbers | 30600AMX00116000 |
| Package insert edition | 第5版 |
| Package insert date | Jun 23, 2025 |
| PMDA document key | 730155_4490408D1021_1 |
| PMDA company code | 730155 |
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: