Medicinal Products

Omniscan 287 mg/ml otopina za injekciju

Note

The Agency for Medicinal Products and Medical Devices issued a Decision on suspension of the marketing authorisation for the concerned medicinal product on 04 December 2017 pursuant to the provision of Article 58, Paragraph 1, Sub-paragraph 3 of Medicinal Products Act (Official Gazette, No. 76/13 and 90/14). The marketing authorisation has been suspended based on Commission Implementing Decision C(2017) 7941 final of 23 November 2017 concerning, in the framework of Article 31 of Directive 2001/83/EC of the European Parliament and of the Council, the marketing authorisations for gadolinium-containing contrast agents for human use which contain one or more of the active substances “gadobenic acid, gadobutrol, gadodiamide, gadopentetic acid, gadoteric acid, gadoteridol, gadoversetamide and gadoxetic acid”, by which Member States are obligated to suspend the marketing authorisations for medicinal products containing gadodiamide, gadopentetic acid and gadoversetamide, since the benefit-risk balance of these medicinal products is no longer favourable. The Agency can lift the suspension if the marketing authorisation holder submits evidence for clinically important benefits that are currently not established in an identified population or indication and which outweigh the risks related to the product or that the product (potentially modified or not) does not undergo significant dechelation and does not lead to retention of gadolinium in tissues.

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