Information about the labelling of the medicinal product Sojourn para inhalata, liquid
Markomed d.o.o., the marketing authorisation holder for the medicinal product Sojourn para inhalata, liquid, has in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) informed physicians about the labelling of the product.
In the second half of 2011, the Ministry of Health gave its consent for the import and placing on the market of the product in the original packaging. Therefore, this product exists in the original packaging in English on the Croatian market. The summary of product characteristics and the package leaflet in Croatian that are attached to the packaging are authorised by HALMED.
The company Minrad International, Inc. is declared on the original packaging as the manufacturer of the product, whereas the company Piramal Healthcare UK limited is declared as the manufacturer in the summary of product characteristics and patient information leaflet, which is in accordance with the dossier submitted in support of the application to HALMED. According to the aforementioned, the labelling of the medicinal product Sojourn para inhalata, liquid that is placed on the Croatian market is in compliance with the consent of the Ministry of Health about the exemption from the labelling in Croatian and the dossier approved by HALMED in the authorisation procedure.