PMDA drug package insert

コミナティRTU筋注5~11歳用1人用

PMDA Prescription drug · ファイザー株式会社 · package insert Aug 31, 2026

Key facts

Brand names コミナティRTU筋注5~11歳用1人用
Nonproprietary names コロナウイルス(SARS-CoV-2)RNAワクチン
Companies 製造販売元/ファイザー株式会社, 技術提携/BIONTECH
Product type Prescription drug
Therapeutic category ウイルスワクチン類
Therapeutic category codes 876313
YJ codes 631341DA9026
Approval numbers 30600AMX00136
Package insert edition 第4版
Package insert date Aug 31, 2026
PMDA document key 672212_631341DA9026_1
PMDA company code 672212

At a glance

  • 1–9 Package insert revisions
  • 1–9 Related PMDA documents
  • 1–9 Safety communications
  • No PMDA review report published
  • Yes 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)