PMDA drug package insert

プログラフ顆粒0.2mg

PMDA Prescription drug · アステラス製薬株式会社 · package insert Jun 24, 2026

Key facts

Brand names プログラフ顆粒0.2mg, プログラフ顆粒1mg
Nonproprietary names タクロリムス水和物
Companies 製造販売/アステラス製薬株式会社
Product type Prescription drug
Therapeutic category 免疫抑制剤
Therapeutic category codes 873999
YJ codes 3999014D1022, 3999014D2029
Approval numbers 21300AMZ00031, 21300AMZ00032
Package insert edition 第5版
Package insert date Jun 24, 2026
PMDA document key 800126_3999014D1022_3
PMDA company code 800126

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:

Browse all PMDA approved drugs and package inserts (Japan)