PMDA drug package insert
エルカルチンFF内用液10%
PMDA Prescription drug · 大塚製薬株式会社 · package insert Nov 9, 2020
Key facts
| Brand names | エルカルチンFF内用液10%, エルカルチンFF内用液10%分包5mL, エルカルチンFF内用液10%分包10mL |
|---|---|
| Nonproprietary names | レボカルニチン |
| Companies | 製造販売元／大塚製薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | レボカルニチン製剤 |
| Therapeutic category codes | 873999 |
| YJ codes | 3999033S1024, 3999033S2020, 3999033S3027 |
| Approval numbers | 22400AMX01483, 22900AMX00953, 22900AMX00954 |
| Package insert edition | 第1版 |
| Package insert date | Nov 9, 2020 |
| PMDA document key | 180078_3999033S1024_1 |
| PMDA company code | 180078 |
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: