Methylprednisolone injection for cattle

Methylprednisolone hydrogen succinate is an ester of the synthetic glucocorticoid methylprednisolone. Veterinary medicinal products containing methylprednisolone hydrogen succinate are used for treatment of inflammatory or allergic conditions and also for treatment and prevention of shock conditions.

Germany considered that the withdrawal period of 6 days for cattle (meat and offal) treated with methylprednisolone hydrogen succinate-containing products might not be sufficient to ensure consumer safety.

On 2 May 2016, Germany initiated a referral procedure under Article 35 of Directive 2001/82/EC for the aforementioned products. The CVMP was requested to review all available residue depletion data and to recommend withdrawal periods for meat and offal derived from treated cattle.

In the absence of product-specific residue depletion data or any other information concerning residues of veterinary medicinal products containing methylprednisolone hydrogen succinate, the CVMP considered the available residue depletion data used for the establishment of maximum residue limits for methylprednisolone (EMEA/MRL/798/01)¹.

¹ CVMP EPMAR for methylprednisolone (EMEA/MRL/798/01)

Based on the evaluation of the currently-available data, the CVMP concluded that the benefit-risk balance for veterinary medicinal products containing methylprednisolone hydrogen succinate presented as solutions for injection is not favourable in the absence of adequate residue depletion data to justify a withdrawal period of 6 days for cattle (meat and offal). The CVMP recommended the refusal of the granting of a marketing authorisation for the target species cattle and variation of the existing marketing authorisations in order to remove any reference to the target species cattle for veterinary medicinal products containing methylprednisolone hydrogen succinate presented as solutions for injection.

The European Commission issued a decision on 20 June 2017.