Orphan designation: humanised IgG1 monoclonal antibody against muscle specific kinase Treatment of spinal muscular atrophy, 16/04/2025 Positive

Orphan designation: humanised IgG1 monoclonal antibody against muscle specific kinase Treatment of spinal muscular atrophy, 16/04/2025 Positive

Guidance on the details of the classification of variations requiring assessment according to Article 62 of Regulation (EU) 2019/6 for veterinary medicinal products and on the documentation to be submitted pursuant to those variations

Guidance on the details of the classification of variations requiring assessment according to Article 62 of Regulation (EU) 2019/6 for veterinary medicinal products and on the documentation to be submitted pursuant to those variations

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