Gadovist is now indicated for use in the paediatric patient group of 7 to 17 years which has been updated in section 4.1 (therapeutic indications).

Section 4.2 (posology and method of administration) has also been updated with the following information:

For children aged 7 years and older and for adolescents the recommended dose is 0.1 mmol Gadovist per kg body weight (equivalent to 0.1 ml Gadovist per kg body weight) for all indications (see section 4.1 Therapeutic indications).

Gadovist is not recommended for use in children below age 7 years due to a lack of sufficient data on gadobutrol elimination in the age group 2 to 6 years.

Gadovist is not recommended for use in children below age 2 years due to a lack of data on efficacy and safety.