PMDA drug package insert
ガリアファーム68Ge/68Gaジェネレータ
PMDA Prescription drug · ノバルティスファーマ株式会社 · package insert Nov 12, 2025
Key facts
| Brand names | ガリアファーム68Ge/68Gaジェネレータ |
|---|---|
| Nonproprietary names | ガリウム（６８Ｇａ）ジェネレータ |
| Companies | 選任外国製造医薬品等製造販売業者／ノバルティスファーマ株式会社, 外国製造医薬品等特例承認取得者／Eckert & Ziegler Radiopharma GmbH（ドイツ） |
| Product type | Prescription drug |
| Therapeutic category | 放射性医薬品 |
| Therapeutic category codes | 874300 |
| YJ codes | 4300457X1029 |
| Approval numbers | 30700AMI00003000 |
| Package insert edition | 第2版 |
| Package insert date | Nov 12, 2025 |
| PMDA document key | 300242_4300457X1029_1 |
| PMDA company code | 300242 |
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: