PMDA drug package insert
乳糖水和物「シオエ」
PMDA Prescription drug · シオエ製薬株式会社 · package insert Jul 28, 2023
Key facts
| Brand names | 乳糖水和物「シオエ」 |
|---|---|
| Nonproprietary names | 乳糖水和物 |
| Companies | 製造販売元／シオエ製薬株式会社, 販売／日本新薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 賦形剤 |
| Therapeutic category codes | 877111 |
| YJ codes | 7111001X1345 |
| Approval numbers | 28A2X00025 |
| Package insert edition | 第1版 |
| Package insert date | Jul 28, 2023 |
| PMDA document key | 340013_7111001X1345_1 |
| PMDA company code | 340013 |
At a glance
- 1–9 Package insert revisions
- None 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: