OVERVIEW OF THE CHOSEN REFERENCE PRODUCT FOR COMPARABILITY Applicant’s product details Name of applicant: Product Name, Strength, Pharmaceutical Form: Overview of the chosen EU reference medicinal product used in the quality comparability exercise Reference Marketing Country of Country Comment Product Name Authorisation Manufacture of Batch number in EU of the Release Strength, (Specify finished Site in Pharmaceutical medicinal country) EEA Form product Overview of the chosen reference medicinal product used in the comparability exercise Reference Marketing Country of Country Study No Comment Product Name Authorisation Manufacture of Batch Strength, number in EU of the Release Pharmaceutical (Specify finished Site in Form country) medicinal EEA product Overview of the chosen reference medicinal product used in the clinical comparability exercise Reference Marketing Country of Country Study Comment Product Name Authorisation Manufacture of Batch No Strength, number in EU of the Release Pharmaceutical (Specify finished Site in Form country) medicinal EEA product
OVERVIEW OF THE CHOSEN REFERENCE PRODUCT FOR COMPARABILITY Applicant’s product details Name of applicant: Product Name, Strength, Pharmaceutical Form: Overview of the chosen EU reference medicinal product used in the quality comparability exercise Reference Product Name Strength, Pharmaceutical Form Marketing Authorisation number in EU (Specify country) Country of Manufacture of the finished medicinal product Country of Batch Release Site in EEA Comment Overview of the chosen reference medicinal product used in the comparability exercise Reference Product Name Strength, Pharmaceutical Form Marketing Authorisation number in EU (Specify country) Country of Manufacture of the finished medicinal product Country of Batch Release Site in EEA Study No Comment Overview of the chosen reference medicinal product used in the clinical comparability exercise Reference Product Name Strength, Pharmaceutical Form Marketing Authorisation number in EU (Specify country) Country of Manufacture of the finished medicinal product Country of Batch Release Site in EEA Study No Comment