PMDA drug package insert
ソマバート皮下注用10mg
PMDA Prescription drug · ファイザー株式会社 · package insert Aug 26, 2022
Key facts
| Brand names | ソマバート皮下注用10mg, ソマバート皮下注用15mg, ソマバート皮下注用20mg |
|---|---|
| Nonproprietary names | ペグビソマント（遺伝子組換え） |
| Companies | 製造販売元／ファイザー株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 成長ホルモン受容体拮抗剤 |
| Therapeutic category codes | 872499 |
| YJ codes | 2499409D1022, 2499409D2029, 2499409D3025 |
| Approval numbers | 21900AMY00004, 21900AMY00005, 21900AMY00006 |
| Package insert edition | 第1版 |
| Package insert date | Aug 26, 2022 |
| PMDA document key | 672212_2499409D1022_3 |
| PMDA company code | 672212 |
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: