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Medicine Status Monitoring SPC PIL XPIL Legal Category Active Ingredient(s) Company STADA Arzneimittel AG BioMarin International Limited Novartis Europharm Limited Hikma Farmacêutica (Portugal), S.A. SERB SAS GE Healthcare AS BioMarin International Limited Octapharma AB Santen Oy Instituto Grifols, S.A. Recordati Rare Diseases MCM Vaccine B.V. Bavarian Nordic A/S Horizon Therapeutics Ireland DAC Novartis Europharm Limited Eurocept International B.V. Actavis Group PTC ehf. GlaxoSmithKline Biologicals S.A. Accord Healthcare S.L.U. KRKA d d., Novo mesto KRKA d d., Novo mesto Accord Healthcare S.L.U. Teva GmbH Accord Healthcare S.L.U. Accord Healthcare S.L.U.