PMDA drug package insert

ツロブテロールテープ0.5mg「MED」

PMDA Prescription drug · メディサ新薬株式会社 · package insert May 7, 2024

Key facts

Brand names ツロブテロールテープ0.5mg「MED」, ツロブテロールテープ1mg「MED」, ツロブテロールテープ2mg「MED」
Nonproprietary names ツロブテロール
Companies 製造販売元/メディサ新薬株式会社, 販売元/杏林製薬株式会社, 発売元/キョーリンリメディオ株式会社
Product type Prescription drug
Therapeutic category 経皮吸収型・気管支拡張剤
Therapeutic category codes 872259
YJ codes 2259707S1110, 2259707S2116, 2259707S3112
Approval numbers 21900AMX00473000, 21900AMX00474000, 21900AMX00475000
Package insert edition 第2版
Package insert date May 7, 2024
PMDA document key 780075_2259707S1110_1
PMDA company code 780075

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:

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