Transcription of PUBLIC ASSESSMENT REPORT …
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PUBLIC ASSESSMENT REPORT …
C B GM E B 1 PUBLIC ASSESSMENT REPORT of the Medicines Evaluation Board in the Netherlands Amoxicilline/Clavulaanzuur Pfizer 500/125 and 875 mg/125 mg film-coated tablets Pfizer , the Netherlands amoxicillin (as trihydrate potassium clavulanate) This ASSESSMENT REPORT is published by the MEB pursuant Article 21 (3) and (4) of Directive 2001/83/EC. The REPORT comments on the registration dossier that was submitted to the MEB and its fellow organisations in all concerned EU member states. It reflects the scientific conclusion reached by the MEB and all concerned member states at the end of the evaluation process and provides a summary of the grounds for approval of a marketing authorisation.
This assessment report shall be updated by a following addendum whenever new information becomes available. General information on the Public Assessment Reports can be found on the website of the MEB.
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