authorised auxiliary medicinal product
as defined in Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16…, Article 2(2), point (10) (Definitions)
a medicinal product authorised in accordance with Regulation (EC) No 726/2004, or in any Member State concerned in accordance with Directive 2001/83/EC, irrespective of changes to the labelling of the medicinal product, which is used as an auxiliary medicinal product