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No : 005/Med/X/22
Re : Safety Statement of Sanofi CHC Syrup Products

Jakarta, 19 October 2022

To Whom It May Concern,

With regards to the current recommendation related to syrup products available in

Indonesia market, and related to below Sanofi CHC products:

Product Name Pack Size NIE/MA License

Bisolvon Kids 60 ml & 125 ml DTL1821207237A1
Bisolvon Extra 60 ml & 125 ml DTL1721207437A1
Bisolvon Solution 50 ml DTL1721206735A1
Mucopect Syrup 15 mg/5 ml (60 ml) DKL1821207337A1
Mucopect Syrup 30 mg/5 ml (60 ml) DKL1821207337B1
Mucopect Drop 20 ml DKL1721206936A1
Dulcolactol 60 ml DBL1721207537A1

Hereby we would like to inform that all of our products listed above DO NOT USE Ethylene
Glycol, Diethylene Glycol (DEG), Propylene Glycol which are currently an issue being
investigated by KEMENKES and BPOM related to safety.

Any query related to medical information can be addressed to

CHCMIIndonesia@sanofi.com. We also commit to monitor any adverse events related
to our products and report regularly to BPOM in accordance to local regulation. Any adverse
event may be directed to CHCPVIndonesia@sanofi.com.

Sanofi is committed to bringing quality and safe products to both patients and consumers.
Rest assured that we will closely monitor this matter.

Sincerely,

Dutta Abhimanyu (Oct 19, 2022 14:10 GMT+8) Fatimah Pitaloca (Oct 19, 2022 13:11 GMT+7)

Abhimanyu Dutta dr. Fatimah Pitaloca

President Director Medical & Pharmacovigilance Lead
Sanofi CHC Indonesia Sanofi CHC Indonesia

Sanofi Indonesia - PT Opella Healthcare Indonesia

GoWork Millennium Centennial Center (MCC), Private Office #3833 Millennium Centennial Center building 38th Floor Jl. Jend. Sudirman Kav 25, Desa/Kelurahan Karet Kuningan, Kec.
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