WINDEXCO SYRUP
Country: Malaysia
Language: English
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Patient Information leaflet
(PIL)
03-12-2020
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Active ingredient:
CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Available from:
WINWA MEDICAL SDN. BHD.
INN (International Name):
CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Units in package:
90 ml; 90 ml
Manufactured by:
WINWA MEDICAL SDN. BHD.
Patient Information leaflet
1
Sheraine Yeoh
From:
Sheraine Yeoh
Sent:
Wednesday, November 25, 2020 3:55 PM
To:
rimup@npra.gov.my
Subject:
FW: Windexco Syrup and Windex Syrup Rimups
Attachments:
Windexco Syrup PIL (EN).pdf; Windex Syrup PIL (BM).pdf; Windex Syrup
PIL (EN).pdf;
Windexco Syrup PIL (BM).pdf
Dear Ms. Bavahrni,
Good day.
The RiMUP of Windexco Syrup and Windex Syrup were updated.
Please refer to attachment for your further evaluation.
Thank you.
Best Regards,
Sheraine Yeoh
QA Regulatory Executive
WINWA MEDICAL SDN BHD (75794-A)
1952, Lorong I.K.S. Bukit Minyak 3, Taman I.K.S. Bukit Minyak,
14000 Bukit Mertajam, Pulau Pinang.
: +604-5079784 (ext: 233) | : +604-5079652
From: Farmakovigilans (Unit Risk Communication (RiMUP))
Sent: Monday, 9 November, 2020 2:53 PM
To: YK Ong
Cc: Sheraine Yeoh
Subject: Windexco Syrup and Windex Syrup Rimups
Dear Ms Ong,
I have rejected
Windexco Syrup and Windex Syrup
RiMUPs today as there are amendments to be made (as in
the files attached).
Once these have been done, please resubmit a clean copy by email for
approval.
Please be reminded that all rejected RiMUPs have to be resubmitted
(clean amended copy) within 20 working days
from the date of rejection email sent to you as stated in the
guideline.
After 20 working days, the RiMUPs submission will be COMPLETELY
REJECTED. Then, the subsequent submission
need to be submitted manually in hardcopy.
Do contact me if you have any further queries.
Thank you
Regards
Bavahrni
Pharmacovigilance section |
2
Centre for Compliance and Quality Control |
National Pharmaceutical Regulatory Division (NPRA)
Ministry of Health Malaysia.
Lot. 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
Tel : 03-78835449
From: Farmakovigilans (Unit Risk Communication (RiMUP))
Sent: Wednesday, October 28, 2020 9:22 AM
To: REG
Subject: Re: Request for Rimup Softcopies - 2
Dear Ms Sheraine,
Received with thanks.
Regards
Bavahrni
Pharmacovigilance section |
Centre for Complian
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