PMDA drug package insert

プレドニゾロン錠5mg「ミタ」

PMDA Prescription drug · キョーリンリメディオ株式会社 · package insert Mar 23, 2026

Key facts

Brand names プレドニゾロン錠5mg「ミタ」
Nonproprietary names プレドニゾロン
Companies 製造販売元/キョーリンリメディオ株式会社, 販売元/杏林製薬株式会社
Product type Prescription drug
Therapeutic category 合成副腎皮質ホルモン剤
Therapeutic category codes 872456
YJ codes 2456001F1396
Approval numbers 21800AMX10301000
Package insert edition 第5版
Package insert date Mar 23, 2026
PMDA document key 480209_2456001F1396_1
PMDA company code 480209

At a glance

  • 1–9 Package insert revisions
  • 10–99 Related PMDA documents
  • 1–9 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:

Browse all PMDA approved drugs and package inserts (Japan)