PMDA drug package insert

カルブロック錠8mg

PMDA Prescription drug · 第一三共株式会社 · package insert Aug 25, 2026

Key facts

Brand names カルブロック錠8mg, カルブロック錠16mg
Nonproprietary names アゼルニジピン
Companies 製造販売元/第一三共株式会社, 技術提携/UBE株式会社
Product type Prescription drug
Therapeutic category 持続性Ca拮抗剤
Therapeutic category codes 872149
YJ codes 2149043F1020, 2149043F2026
Approval numbers 21500AMZ00030, 21500AMZ00031
Package insert edition 第6版
Package insert date Aug 25, 2026
PMDA document key 430574_2149043F1020_2
PMDA company code 430574

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:

Browse all PMDA approved drugs and package inserts (Japan)