JP Drafts (September 2016)

JP drafts for public comments, September 1 - 30, 2016

New monographs (Chemical drug)

• Acarbose (001-1609eng.pdf)
• Acarbose Tablets (002-1609eng.pdf)
• Chloramphenicol and Colistin Sodium Methanesulfonate Ophthalmic Solution (003-1609eng.pdf)
• Clomipramine Hydrochloride Tablets (004-1609eng.pdf)
• Clotiazepam Tablets (005-1609eng.pdf)
• Entacapone (006-1609eng.pdf)
• Entacapone Tablets (007-1609eng.pdf)
• Insulin Aspart (Genetical Recombination) (008-1609eng.pdf)
• Irbesartan Tablets (009-1609eng.pdf)
• Pazufloxacin Mesilate Injection (010-1609eng.pdf)
• Pyridoxal Phosphate Hydrate (011-1609eng.pdf)
• Tramadol Hydrochloride (012-1609eng.pdf)
• Zonisamide Tablets (013-1609eng.pdf)

New monographs (Crude drug)

• Goreisan Extract (014-1609eng.pdf)

Ultraviolet-visible reference spectra

• Entacapone (015-1609eng.pdf)
• Pyridoxal Phosphate Hydrate (016-1609eng.pdf)
• Tramadol Hydrochloride (017-1609eng.pdf)

Infrared reference spectra

• Acarbose (018-1609eng.pdf)
• Entacapone (019-1609eng.pdf)
• Pyridoxal Phosphate Hydrate (020-1609eng.pdf)
• Tramadol Hydrochloride (021-1609eng.pdf)

To send the comment on these drafts, the guidance is as follows:
 

1. Download the form for comments in  Word format
2. Fill in the form
3. Prepare and attach the supportive data that scientifically validate the comment when appropriate
4. Send it to the email address: JPdraft1609eng@pmda.go.jp

Related Information

• Columns (Chemical drug)
   

Note: The information provided with the comment 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).