Information of the Management Board of Celon Pharma S.A..
The Management Board of Celon Pharma S.A. announced that on 10 August 2018 the Chief Pharmaceutical Inspector repealed its decision No. 4/WS/2018 of 21.06.2018 on the voluntary, temporary withholding of one batch of Salmex, (500 µg + 50 µg), number 223020018.
The results of tests conducted on the suspended batch confirmed that it meets all quality requirements, including appropriate microbiological specification criteria.
The procedure, carried out at the request of the MAH, was of a preventive nature and was standard, provided for in such cases by the pharmaceutical law.
Repealing the above-mentioned decision of the Chief Pharmaceutical Inspector decision will allow the re-release of this batch.