PMDA drug package insert
ニューロライト注射液 第一（400MBq）
PMDA Prescription drug · PDRファーマ株式会社 · package insert Jun 1, 2026
Key facts
| Brand names | ニューロライト注射液 第一（400MBq）, ニューロライト注射液 第一（600MBq） |
|---|---|
| Nonproprietary names | エチレンジシスティネートオキソテクネチウム（９９ｍＴｃ） |
| Companies | 製造販売元／PDRファーマ株式会社, 技術提携先／SHINE SPECT USA, LLC（米国） |
| Product type | Prescription drug |
| Therapeutic category | 放射性医薬品／局所脳血流診断薬 |
| Therapeutic category codes | 874300 |
| YJ codes | 4300443A2020, 4300443A1024 |
| Approval numbers | 20600AMZ00036000 |
| Package insert edition | 第3版 |
| Package insert date | Jun 1, 2026 |
| PMDA document key | 651410_4300443A1024_2 |
| PMDA company code | 651410 |
At a glance
- 1–9 Package insert revisions
- 1–9 Related PMDA documents
- 1–9 Safety communications
- No 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: