PMDA drug package insert

セチリジン塩酸塩錠5mg「ツルハラ」

PMDA Prescription drug · 鶴原製薬株式会社 · package insert Nov 21, 2022

Key facts

Brand names セチリジン塩酸塩錠5mg「ツルハラ」, セチリジン塩酸塩錠10mg「ツルハラ」
Nonproprietary names セチリジン塩酸塩
Companies 製造販売元/鶴原製薬株式会社
Product type Prescription drug
Therapeutic category 持続性選択H1受容体拮抗・アレルギー性疾患治療剤
Therapeutic category codes 87449
YJ codes 4490020F1268, 4490020F2264
Approval numbers 21900AMX00550000, 21900AMX00555000
Package insert edition 第1版
Package insert date Nov 21, 2022
PMDA document key 460028_4490020F1268_1
PMDA company code 460028

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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