PL EN

EMA: Draft guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and / or intramuscular administration (SCIg / IMIg)

06.12.2012
This guideline describes the information to be documented when an application is made for a marketing authorisation for a human normal immunoglobulin for subcutaneous or intramuscular use (SCIg / IMIg). The guidance covers biological data, clinical trials and patient follow-up. Guidance is also provided for authorised products where a significant change in the manufacturing process has been made.

kapitał ludzki

fundusz społeczny

Narodowe Centrum Badań i Rozwoju

innowacyjna gospodarka

rozwój regionalny