PMDA drug package insert

カルボシステイン錠250mg「TCK」

PMDA Prescription drug · 辰巳化学株式会社 · package insert Oct 20, 2023

Key facts

Brand names カルボシステイン錠250mg「TCK」, カルボシステイン錠500mg「TCK」
Nonproprietary names L-カルボシステイン
Companies 製造販売元/辰巳化学株式会社
Product type Prescription drug
Therapeutic category 気道粘液調整・粘膜正常化剤
Therapeutic category codes 872233
YJ codes 2233002F1336, 2233002F2154
Approval numbers 23000AMX00104000, 23000AMX00105000
Package insert edition 第1版
Package insert date Oct 20, 2023
PMDA document key 400278_2233002F1336_1
PMDA company code 400278

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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