Sanohex

Sanohex is a medicine in a pressurised inhaler that contains salbutamol as active substance. Salbutamol is a beta2-adrenergic receptor agonist. This means that salbutamol activates the beta2-receptors in the body. When given by inhalation as in Sanohex, salbutamol directly activates the beta2-receptors in the respiratory system. This makes the airways widen, allowing the air to flow more freely.

Sanohex is used to treat the breathing difficulties caused by asthma and chronic obstructive pulmonary disease (COPD). It can also be used to prevent asthma symptoms caused by exercise or other triggering factors, such as house dust, pollen, cats, dogs and cigarette smoke. Sanohex is used to relieve symptoms, and its use should not delay the use of inhaled steroids. Sanohex is a 'generic medicine'. This means that Sanohex is similar to a 'reference medicine' already authorised in the European Union (EU) called Sultanol inhaler.

Hexal AG submitted Sanohex to the Swedish medicines regulatory agency for a decentralised procedure on 5 December 2006. This is a procedure when one Member State (the 'reference Member State', in this instance Sweden) assesses a medicine with a view of granting a marketing authorisation that will be valid in this country as well as in other member states (the 'concerned Member States', in this instance Austria, Germany, Ireland and Spain). These member states were not able to reach an agreement. On 4 March 2008, the Swedish medicines regulatory agency referred the matter to the CHMP.

The grounds for the referral were concerns regarding that there was not enough data showing that Sanohex is equivalent to the reference medicine. Concerns were also raised regarding how to store the inhaler and the effect of the orientation of the inhaler on the delivery of the medicine.

Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Sanohex outweigh its risks, and that therefore the marketing authorisation for Sanohex should be granted in all concerned member states.