PMDA drug package insert
ステイセーフバランス 1
PMDA Prescription drug · フレゼニウス メディカル ケア ジャパン株式会社 · package insert Feb 1, 2024
Key facts
| Brand names | ステイセーフバランス 1, 1.5 腹膜透析液, 2.5 腹膜透析液, 4.25 腹膜透析液 |
|---|---|
| Nonproprietary names | 腹膜透析液 |
| Companies | 製造販売業者／フレゼニウス メディカル ケア ジャパン株式会社, 販売業者／株式会社ジェイ・エム・エス |
| Product type | Prescription drug |
| Therapeutic category | 腹膜透析液 |
| Therapeutic category codes | 87342 |
| YJ codes | 3420419A5054, 3420419A7065, 3420419A8061, 3420419A9050, 3420420A5057, 3420420A7068, 3420420A8064, 3420420A9052, 3420421A7054, 3420421A8050, 3420421A4047, 3420421A6058 |
| Approval numbers | 22000AMX02014000, 22000AMX02037000, 22000AMX02038000 |
| Package insert edition | 第1版 |
| Package insert date | Feb 1, 2024 |
| PMDA document key | 670394_3420419A5054_1 |
| PMDA company code | 670394 |
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: