PMDA drug package insert
トルバプタンOD錠7.5mg「ニプロ」
PMDA Prescription drug · ニプロ株式会社 · package insert Apr 20, 2026
Key facts
| Brand names | トルバプタンOD錠7.5mg「ニプロ」, トルバプタンOD錠15mg「ニプロ」 |
|---|---|
| Nonproprietary names | トルバプタン |
| Companies | 製造販売元／ニプロ株式会社, 販売元／株式会社フェルゼンファーマ |
| Product type | Prescription drug |
| Therapeutic category | V2-受容体拮抗剤 |
| Therapeutic category codes | 87213987249 |
| YJ codes | 2139011F3069, 2139011F4090 |
| Approval numbers | 30400AMX00155, 30400AMX00335 |
| Package insert edition | 第3版 |
| Package insert date | Apr 20, 2026 |
| PMDA document key | 530100_2139011F3069_2 |
| PMDA company code | 530100 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- None Safety communications
- No 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: