Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 January 2015

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12/01/2015

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 January 2015

PRAC considers risk of severe allergic reactions with ambroxol- and bromhexine-containing medicines to be small

The Pharmacovigilance Risk Assessment Committee (PRAC) has completed a review of medicines containing ambroxol or bromhexine, and has concluded that the risk of severe allergic reactions is small, but that the product information should be updated.

The PRAC recommended adding a new warning, together with advice to discontinue treatment immediately if symptoms of allergy or severe skin reactions occur.

More information is provided in the table below.

Agenda

 
Agenda - PRAC draft agenda of meeting 6-9 January 2015

  

Recommendation by PRAC

Ambroxol and bromhexine hydrochloride-containing medicines

Article-31 referral: Ambroxol and bromhexine hydrochloride-containing medicines

 

Summary of PRAC recommendation

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Related information

Contact point:

Monika Benstetter
Tel. +44 (0)20 3660 8427
E-mail: press@ema.europa.eu