PMDA drug package insert
ゾルトファイ配合注 フレックスタッチ
PMDA Prescription drug · ノボ ノルディスク ファーマ株式会社 · package insert May 29, 2026
Key facts
| Brand names | ゾルトファイ配合注 フレックスタッチ |
|---|---|
| Nonproprietary names | インスリン デグルデク（遺伝子組換え）・リラグルチド（遺伝子組換え）配合剤 |
| Companies | 製造販売元／ノボ ノルディスク ファーマ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 持効型溶解インスリンアナログ/ヒトGLP-1アナログ 配合注射液 |
| Therapeutic category codes | 873969 |
| YJ codes | 3969500G1029 |
| Approval numbers | 30100AMX00020000 |
| Package insert edition | 第8版 |
| Package insert date | May 29, 2026 |
| PMDA document key | 620023_3969500G1029_1 |
| PMDA company code | 620023 |
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: