Farmak International Receives Marketing Authorizations for Gadobutrol in Europe
Farmak International reports that marketing authorizations (MAs) have been granted for Gadobutrol in three European markets.
Approvals were granted in Slovakia, Germany and the Czech Republic through Decentralized Procedure (DCP) and subsequent national regulatory phases. They cover Gadobutrol solution, in accordance with the approved Product Information (Summary of Product Characteristics, SmPC) in each respective country.
The authorized presentations comprise gadobutrol 1 mmol/ml solution for injection in vials and solution for injection in prefilled syringes. The approved pack sizes are as follows:
▶ Prefilled syringes – 5ml, 7.5 ml, 10 ml, 15 ml – pack of 1 or 5 syringes
▶ Vials – 2 ml, 7.5 ml, 10 ml, 15 ml, 30 ml, 65 ml – pack of 1 or 10 vials
Presentation details, including pack sizes, may differ by country and are specified in the respective marketing authorization.
Gadobutrol is a gadolinium-based contrast agent used in magnetic resonance imaging (MRI). This information is intended for healthcare professionals only and is provided for regulatory and informational purposes. It does not constitute promotion or recommendation for use.
Product availability, regulatory status, and commercialization rights vary by country and may be restricted by intellectual property rights or other legal requirements. Products are not offered for sale or supplied where such rights prohibit sale or would result in intellectual property rights infringement. Customers are responsible for verifying all relevant intellectual property rights (including patents and SPCs) and for ensuring compliance with local laws.
