PL EN

EMA: Draft guideline on the clinical investigation of hepatitis-B immunoglobulins

06.12.2012
This guideline describes the information to be documented when an application is made for a marketing authorisation for a hepatitis-B immunoglobulin. The guidance covers biological data, pharmacokinetics, clinical trials and patient follow-up. Guidance is also provided for authorised products where a significant change in the manufacturing process has been made.

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