PMDA drug package insert
ジェノトロピンTC注用5.3mg
PMDA Prescription drug · ファイザー株式会社 · package insert Dec 22, 2023
Key facts
| Brand names | ジェノトロピンTC注用5.3mg, ジェノトロピンTC注用12mg |
|---|---|
| Nonproprietary names | ソマトロピン（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 | 遺伝子組換え天然型ヒト成長ホルモン製剤 |
| Therapeutic category codes | 872412 |
| YJ codes | 2412402D9038, 2412402L4057 |
| Approval numbers | 22100AMX00426, 22100AMX00425 |
| Package insert edition | 第3版 効能変更、用法及び用量変更 |
| Package insert date | Dec 22, 2023 |
| PMDA document key | 672212_2412402D9038_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: