JP Drafts (June 2024) No.2

JP drafts for public comments, June 3, 2024 - August 31, 2024

New monographs 

• L-Carbocisteine for Syrup[127KB] (003-2406eng.pdf)
• Levetiracetam[175KB] (004-2406eng.pdf)
• Levetiracetam Tablets[142KB] (005-2406eng.pdf)
• Midodrine Hydrochloride[161KB] (006-2406eng.pdf)
• Midodrine Hydrochloride Tablets[135KB] (007-2406eng.pdf)
• Midodrine Hydrochloride Orally Disintegrating Tablets[138KB] (008-2406eng.pdf)

Ultraviolet-visible reference spectra

• Midodrine Hydrochloride[30.7KB] (009-2406eng.pdf)

Infrared reference spectra

• Levetiracetam[101KB] (010-2406eng.pdf)
• Midodrine Hydrochloride[79.9KB] (011-2406eng.pdf)

 

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

1. Download the form for comments in Word format[67.0KB]
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: JPdraft-eng[at]pmda.go.jp

Note:
For the purpose of security, this email address is partly incorrect. Please replace [at] with @ when sending an email.

Related Information

• Columns (Chemical drug)

 

Note:
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.