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https://www.ema.europa.eu/documents/variation-report/dafiro-hct-h-c-1160-ws-0359-epar-assessment-report-variation_en.pdf
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https://www.ema.europa.eu/documents/variation-report/dafiro-hct-h-c-1160-ws-0359-epar-assessment-report-variation_en.pdf