PMDA drug package insert
ビオプテン顆粒2.5%
PMDA Prescription drug · 第一三共株式会社 · package insert May 25, 2021
Key facts
| Brand names | ビオプテン顆粒2.5%, ビオプテン顆粒10% |
|---|---|
| Nonproprietary names | サプロプテリン塩酸塩 |
| Companies | 製造販売元／第一三共株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 天然型テトラヒドロビオプテリン製剤 |
| Therapeutic category codes | 873999 |
| YJ codes | 3999012D1023, 3999012D2020 |
| Approval numbers | 20400AMZ00758, 22500AMX01774 |
| Package insert edition | 第2版 |
| Package insert date | May 25, 2021 |
| PMDA document key | 430574_3999012D1023_3 |
| PMDA company code | 430574 |
At a glance
- 1–9 Package insert revisions
- 1–9 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: