Fusafungine containing medicinal products for oromucosal and nasal use

• Fusafungine nose and mouth sprays have been used to treat upper airway infections.
• These sprays are being taken off the market in the EU because of rare cases of serious allergic reactions and the lack of strong evidence that these medicines work.
• Upper airway infections are usually mild and self-limiting.
• Healthcare professionals should advise patients on alternative treatments, if needed.
• Patients with any questions should speak to their healthcare professional.

Fusafungine is an antibiotic and anti-inflammatory medicine used in the form of a nasal and oromucosal (to be applied to the mouth) spray for the treatment of the following infections of the upper airways: sinusitis (sinus infection), rhinitis (stuffy and runny nose), rhinopharyngitis (common cold), tonsillitis (inflammation of the tonsils caused by an infection) and laryngitis (inflammation of the voice box).

Fusafungine-containing medicines have been available in several EU countries for over 50 years. They were authorised through national approval procedures under various trade names (Bioparox, Fusaloyos, Locabiotal and Locabiosol) in the following countries: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Portugal, Romania, Slovakia and Spain.

In some Member States, these medicines were available without prescription.

The review of fusafungine-containing medicines was initiated on 11 September 2015 at the request of Italy, under Article 31 of Directive 2001/83/EC.

The review has been carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations. During its review the PRAC consulted EMA's paediatric scientific committee as well as experts in the field of anti-infective medicines.

As fusafungine-containing medicines are all authorised nationally, the PRAC recommendations were forwarded to the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), which adopted a final position on 31 March 2016.

The CMDh is a regulatory body representing EU Member States as well as Iceland, Liechtenstein and Norway. It is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.

As the CMDh adopted its position by consensus, the measures recommended by the PRAC will be implemented directly by the Member States where the medicines are authorised, according to an agreed timetable.