PMDA drug package insert
ペンタサ注腸1g
PMDA Prescription drug · フェリング・ファーマ株式会社 · package insert Apr 21, 2026
Key facts
| Brand names | ペンタサ注腸1g |
|---|---|
| Nonproprietary names | メサラジン |
| Companies | 製造販売元（輸入）／フェリング・ファーマ株式会社, 販売元／杏林製薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 潰瘍性大腸炎治療剤 |
| Therapeutic category codes | 872399 |
| YJ codes | 2399715X1023 |
| Approval numbers | 21400AMY00240000 |
| Package insert edition | 第7版 |
| Package insert date | Apr 21, 2026 |
| PMDA document key | 670666_2399715X1023_5 |
| PMDA company code | 670666 |
At a glance
- 1–9 Package insert revisions
- 10–99 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: