Loratadine Sandoz 10, 10 mg tablets - public assessment report suspension of marketing authorisation

During the Repeat Use procedure for this product, it was found that bio-equivalence had not been demonstrated in accordance with the current guidelines. The company subsequently submitted a new study, in which the results were found to be inadequate. In accordance with the advice from the CHMP, the MEB suspended Loratadine Sandoz 10, tablets on 24 September 2009. The products Loratidine 10 mg tablets (RVG 25766) and Otrivin nasal allergy loratadine 10 mg tablets (RVG 25767) were also suspended, as these were authorised on the basis of the same bio-study.