PMDA drug package insert
チャンピックス錠0.5mg
PMDA Prescription drug · ファイザー株式会社 · package insert Sep 2, 2024
Key facts
| Brand names | チャンピックス錠0.5mg, チャンピックス錠1mg |
|---|---|
| Nonproprietary names | バレニクリン酒石酸塩 |
| Companies | 製造販売元／ファイザー株式会社 |
| Product type | Prescription drug |
| Therapeutic category | α4β2ニコチン受容体部分作動薬（禁煙補助薬） |
| Therapeutic category codes | 87799 |
| YJ codes | 7990003F1028, 7990003F2024 |
| Approval numbers | 22000AMX00020, 22000AMX00021 |
| Package insert edition | 第1版 |
| Package insert date | Sep 2, 2024 |
| PMDA document key | 672212_7990003F1028_3 |
| PMDA company code | 672212 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- 1–9 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: