Vaststelling van richtlijnen voor immunoglobulinen

Vaststelling van richtlijnen voor immunoglobulinen

 In Nieuws
0

We are pleased to inform you that the Guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg), as well as the guideline on core SmPC for human normal immunoglobulin for intravenous administration (IVIg), have been recently adopted and published on the EMA website:

  1. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2018/07/WC500252346.pdf
  2. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2018/07/WC500252345.pdf

The revisions concern mainly 2 areas:

  • The change wording of the Secondary Immunodeficiencies (SID);
  • The inclusion of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Multifocal Motor Neuropathy (MNN) indications.

The guidelines will come into effect on 1st January 2019, although companies can already implement the new changes.

In addition, the revision on the core SmPC on human albumin and FVIII guideline, and core SmPC have also been adopted and will be published very soon.

ACRON Secretariaat
Recent Posts