PMDA drug package insert

ダラシンS注射液300mg

PMDA Prescription drug · ファイザー株式会社 · package insert Feb 10, 2026

Key facts

Brand names ダラシンS注射液300mg, ダラシンS注射液600mg
Nonproprietary names クリンダマイシンリン酸エステル
Companies 製造販売元/ファイザー株式会社
Product type Prescription drug
Therapeutic category 抗生物質製剤
Therapeutic category codes 876112
YJ codes 6112401A1100, 6112401A2123
Approval numbers 21900AMX01708, 21900AMX01709
Package insert edition 第2版
Package insert date Feb 10, 2026
PMDA document key 672212_6112401A1100_3
PMDA company code 672212

At a glance

  • 1–9 Package insert revisions
  • 10–99 Related PMDA documents
  • None Safety communications
  • Yes 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)