Country: Malaysia
Language: English
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
WINWA MEDICAL SDN. BHD.
CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
90 ml; 90 ml
WINWA MEDICAL SDN. BHD.
1 Sheraine Yeoh From: Sheraine YeohSent: 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)) Read the complete documentSent: 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