PMDA drug package insert

ブデホル吸入粉末剤30吸入「ニプロ」

PMDA Prescription drug · ニプロ株式会社 · package insert Apr 24, 2025

Key facts

Brand names ブデホル吸入粉末剤30吸入「ニプロ」, ブデホル吸入粉末剤60吸入「ニプロ」
Nonproprietary names ブデソニド・ホルモテロールフマル酸塩水和物
Companies 製造販売元/ニプロ株式会社
Product type Prescription drug
Therapeutic category ドライパウダー吸入式喘息・COPD治療配合剤
Therapeutic category codes 87229
YJ codes 2290801G1053, 2290801G2050
Approval numbers 23100AMX00134, 23100AMX00135
Package insert edition 第1版
Package insert date Apr 24, 2025
PMDA document key 530100_2290801G1053_1
PMDA company code 530100

At a glance

  • 1–9 Package insert revisions
  • 1–9 Related PMDA documents
  • None 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)