PMDA drug package insert

ビベスピエアロスフィア120吸入

PMDA Prescription drug · アストラゼネカ株式会社 · package insert Aug 4, 2025

Key facts

Brand names ビベスピエアロスフィア120吸入
Nonproprietary names グリコピロニウム臭化物・ホルモテロールフマル酸塩水和物
Companies 製造販売元/アストラゼネカ株式会社
Product type Prescription drug
Therapeutic category COPD治療配合剤
Therapeutic category codes 872259
YJ codes 2259808G2027
Approval numbers 30100AMX00005
Package insert edition 第6版
Package insert date Aug 4, 2025
PMDA document key 670227_2259808G2027_1
PMDA company code 670227

At a glance

  • 1–9 Package insert revisions
  • 1–9 Related PMDA documents
  • None Safety communications
  • Yes PMDA review report published
  • Yes 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)