承認 against Moderunaziyapan K.K.
モデルナ・ジャパン株式会社 (Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices)
Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical DevicesMinistry of Health, Labour and WelfareSeptember 12, 2022
Action summary
- Company
- Moderunaziyapan K.K.RomanizedOriginal: モデルナ・ジャパン株式会社Corporate Number: 4010401159678
- Governing law
- Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices薬機法
- Action type
- 承認承認
- Action date
- September 12, 2022
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
Violation
Machine-translated summary — verify against original
The approved formulations are Cominaty RTU intramuscular injection and Spikevax intramuscular injection, and approval was granted for partial changes to their indications, usage, and dosage.
Show original Japanese text
承認された製剤は、コミナティRTU筋注とスパイクバックス筋注であり、それぞれの効能・効果、用法・用量の一部変更について承認された。
Source
Original Ministry of Health, Labour and Welfare announcement (in Japanese)The original Japanese disclosure is the authoritative record.
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Language
日本語版を見る (Japanese)Company info
- English name
- Moderunaziyapan K.K. Romanized
- Japanese name
- モデルナ・ジャパン株式会社
- Corporate Number
- 4010401159678
- Registered address
- 東京都港区虎ノ門４丁目１番１号
About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.