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Propylene glycol used as an excipient

30 Churchill Place Canary Wharf London E14 5EU United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged. 9 October 2017 EMA/CHMP/334655/2013 Committee for Human Medicinal Products (CHMP) Propylene glycol used as an excipient Report published in support of the Questions and answers on Propylene glycol used as an excipient in medicinal products for human use (EMA/CHMP/704195/2013). Propylene glycol used as an excipient EMA/CHMP/334655/2013 Page 2/97 Propylene glycol used as an excipient Table of contents Introduction.

if used in adults and 200 mg/kg if used in children. These thresholds were also advised by the Dutch Medicines Evaluation Board as maximum tolerable daily dosages of propylene glycol in cough medicines [108]. Propylene glycol used as an excipient EMA/CHMP/334655/2013 Page 5/97 While propylene glycol is generally considered safe as a food ...

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