PMDA drug package insert
ビオスリー配合散
PMDA Prescription drug · 東亜薬品工業株式会社 · package insert Apr 1, 2022
Key facts
| Brand names | ビオスリー配合散, ビオスリー配合錠, ビオスリー配合OD錠 |
|---|---|
| Nonproprietary names | 酪酸菌配合剤 |
| Companies | 製造販売元／東亜薬品工業株式会社, 発売元／東亜新薬株式会社, 販売／鳥居薬品株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 活性生菌製剤 |
| Therapeutic category codes | 872316 |
| YJ codes | 2316017B1041, 2316017F1035, 2316017F2023 |
| Approval numbers | 22100AMX01635000, 22100AMX01636000, 22700AMX00737000 |
| Package insert edition | 第1版 |
| Package insert date | Apr 1, 2022 |
| PMDA document key | 480019_2316017B1041_1 |
| PMDA company code | 480019 |
At a glance
- 1–9 Package insert revisions
- 1–9 Related PMDA documents
- None 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: