Celon Pharma S.A. voluntarily withdraws three batches of Salmex (500 µg + 50 µg)/ inhalation dose from the market. Availability of the product for patients is stable.

Celon Pharma S.A. decided to voluntarily withdraw three batches of Salmex (500 µg + 50 µg), used in treatment of asthma and COPD, from the market. Despite this fact, availability of the product for patients remains stable.

Salmex (500 µg + 50 µg)/ inhalation dose were withdrawn.

223044015 12.2016
223036115 11.2016
223030215 10.2016

The reason for the decision was a suspicion of the inhaler's possible malfunction in the above-listed batches of the product, easily detectable by the patient. It is manifested in the lack of the distinctive sound which normally signals that the dose of the drug has been properly loaded in the device. However, the situation does not constitute a threat to the health and life of the patients using the drug. Due to the fact that the problem is easily identifiable, there is no risk of the patient taking the dose incorrectly. Availability of the product on the market remains stable and all reported cases are examined individually under the complaint procedure implemented by the pharmacy which sold the product in question, immediately after the patient reports the problem. Celon Pharma S.A., as the product's marketing authorisation holder, will make every effort to ensure that a new device is received by the patient as soon as possible.

The cause of the problem which prompted the withdrawal of the three batches has been eliminated and no longer impacts the product's current manufacturing process.

The voluntary withdrawal of the above-listed batches was carried out in accordance with a standard procedure provided for such situations in the pharmaceutical law.

Magdalena Sobiecka – Grzenda, Head of Quality Assurance, Qualified Person, Celon Pharma S.A.: The issue with the jamming inhaler may, but does not necessarily have to occur; most importantly it does pose a risk for patients, as it is easily detectable. The present decision on withdraw of the three batches is the result of an analysis of complaints which were reported to us with a certain delay It results both from the procedure provided for in the pharmaceutical law and the specifics of using our product by patients. We have recognised all complaints reported in this case and have taken actions to ensure that patients promptly receive new packages of the product. We wish to ensure our patients that availability of the product is stable and Celon Pharma S.A. is cooperating with the competent pharmaceutical supervision authorities in this area.

A special hotline number has been launched for wholesalers, pharmacies and patients who wish to learn more about this subject: 882-149-533, available every day from 9 a.m.to 5 p.m. All interested parties can also contact us via e-mail at: [email protected]

Decision No. 39/WC/2015 of 30 September 2015