SINECOD Syrup Ref.[51127] Active ingredients: Butamirate

Source: Medicines Authority (MT)  Revision Year: 2020  Publisher: GlaxoSmithKline Consumer Healthcare Hellas Single Member Societe Anonyme, the distinctive title GSK CH Hellas Single Member S.A., 274 Kifissias Ave, 15232, Halandri, Athens, Greece

Product name and form

SINECOD Syrup 7.5 mg/5ml.

Pharmaceutical Form

Syrup.

Qualitative and quantitative composition

Butamirate Citrate 7.5 mg/5 ml.

Butamirate Citrate: C24H37NO10
2-[2-(diethylamino)-ethoxy]ethyl-2-phenylbutyrate Citrate

For a full list of excipients see section 6.1.

Active Ingredient Description
Butamirate

Butamirate (or brospamin) is a cough suppressant. It binds to the cough center in the medulla oblongata, more specifically the dextromethorphan-binding site in guinea pig brain with high affinity.
List of Excipients

Sorbitol sol.
Glycerol
Saccharin sodium
Benzoic acid
Vanillin
Ethanol sol.
Sodium hydroxide sol.
Water purified

Pack sizes and marketing

Glass bottle containing 200 ml or 250 ml of syrup.

Package includes a measuring cup.

Marketing authorization holder

GlaxoSmithKline Consumer Healthcare Hellas Single Member Societe Anonyme, the distinctive title “GSK CH Hellas Single Member S.A.”, 274 Kifissias Ave, 15232, Halandri, Athens, Greece

Marketing authorization dates and numbers

MA1177/00101

19th April 2007 / 08th October 2012

Drugs

Drug Countries
SINECOD Cyprus, Croatia, Malta, Poland, Romania, Turkey
 
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