JP drafts for public comments, March 1, 2023 - May 31, 2023
New monographs
- Aripiprazole[134KB] (008-2303eng.pdf)
- Febuxostat[127KB] (009-2303eng.pdf)
- Febuxostat Tablets[124KB] (010-2303eng.pdf)
- Gefitinib Tablets[96.6KB] (011-2303eng.pdf)
- Goserelin Acetate[141KB] (012-2303eng.pdf)
- Lornoxicam[129KB] (013-2303eng.pdf)
- Lornoxicam Tablets[136KB] (014-2303eng.pdf)
- Oxaliplatin[200KB] (015-2303eng.pdf)
- Oxaliplatin Injection[130KB] (016-2303eng.pdf)
- Tolvaptan[133KB] (017-2303eng.pdf)
- Tolvaptan Tablets[112KB] (018-2303eng.pdf)
New monographs (Crude drug)
- Shin’iseihaito Extract[148KB] (019-2303eng.pdf)
Ultraviolet-visible reference spectra
- Aripiprazole[76.9KB] (020-2303eng.pdf)
- Febuxostat[78.7KB] (021-2303eng.pdf)
- Lornoxicam[76.9KB] (022-2303eng.pdf)
- Oxaliplatin[76.8KB] (023-2303eng.pdf)
- Tolvaptan[76.7KB] (024-2303eng.pdf)
Infrared reference spectra
- Aripiprazole[116KB] (025-2303eng.pdf)
- Febuxostat[112KB] (026-2303eng.pdf)
- Lornoxicam[111KB] (027-2303eng.pdf)
- Oxaliplatin[108KB] (028-2303eng.pdf)
- Tolvaptan[110KB] (029-2303eng.pdf)
To send the comment on these drafts, the guidance is as follows:
- Download the form for comments in Word format[67.0KB]
- Fill in the form
- Prepare and attach the supportive data that scientifically validate the comment when appropriate
- Send it to the email address: JPdraft-eng[at]pmda.go.jp
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Related Information
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The information submitted with the comments may be released to the public whenever necessary (except the individual name, organization, address, telephone & fax numbers and e-mail address or the attached supportive data).
Your comments will be considered for the preparation of JP final drafts, but no individual response will be made to each comment.