PMDA drug package insert
エスシタロプラム錠10mg「明治」
PMDA Prescription drug · Meiji Seika ファルマ株式会社 · package insert Mar 5, 2024
Key facts
| Brand names | エスシタロプラム錠10mg「明治」, エスシタロプラム錠20mg「明治」 |
|---|---|
| Nonproprietary names | エスシタロプラムシュウ酸塩 |
| Companies | 製造販売元／Meiji Seika ファルマ株式会社, 販売元／株式会社フェルゼンファーマ |
| Product type | Prescription drug |
| Therapeutic category | 選択的セロトニン再取り込み阻害剤（SSRI） |
| Therapeutic category codes | 871179 |
| YJ codes | 1179054F1103, 1179054F2100 |
| Approval numbers | 30400AMX00338000, 30400AMX00339000 |
| Package insert edition | 第4版、承認条件の項削除 |
| Package insert date | Mar 5, 2024 |
| PMDA document key | 780009_1179054F1103_2 |
| PMDA company code | 780009 |
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: