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EMEA: Concept paper on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use

10.04.2009
Unwanted immunogenicity is a significant problem with therapeutic biologicals. The clinical problems associated with unwanted immunogenicity vary in nature and incidence. The importance of the ...

EMEA: Adopted guideline on similar biological medicinal products containing low-molecular-weight-heparins

10.04.2009
This guideline lays down the non-clinical and clinical requirements for low molecular weight heparins (LMWHs, low molecular mass heparins, LMMH) containing medicinal products claiming to be ...

EMEA: Community herbal monograph

10.04.2009
Community herbal monograph on Centaurii herba Centaurium erythraea Rafn., herba (centaury herb) ...

EMEA: Dossier requirements for Post-authorisation submissions in the centralised procedure

10.04.2009
Dossier requirements for (Co-) Rapporteur and CHMP members ...

EMEA: QRD Recommendations on the expression of strength in the name of centrally authorised human medicinal products

10.04.2009
Directive 2001/83/EC requires a medicinal product to be labelled as “(invented) name + strength + pharmaceutical form”. This is considered to be the full name of the product, therefore ...

EMEA: Guideline on Plasma-Derived Medicinal Products

10.04.2009
This guideline lays down the requirements for the collection of starting material, the manufacturing and the quality control of plasma-derived medicinal products. Specific attention will be given ...

EMEA: Community herbal monograph

10.04.2009
Draft documents for the community herbal monograph on Gentianae radix Gentiana lutea L., radix (gentian root) ...

EMEA: Guideline on Core SmPC for Human Fibrinogen Products - Overview of comments on above draft guideline

25.03.2009
EMEA:
Guideline on Core SmPC for Human Fibrinogen Products - Overview of comments on above draft guideline. This guideline describes the information to be included in the Summary of ...

EMEA: Adopted documents for Community Herbal Monograph on Boldi folium Peumus boldus Molina (Boldo leaf)

25.03.2009
EMEA:
Adopted documents for Community Herbal Monograph on Boldi folium Peumus boldus Molina (Boldo leaf) – Assessment report. ...

EMEA: Overview of comments received on draft guideline on Carcinogenicity Evaluation of Medicinal Products for the Treatment of HIV Infection

25.03.2009
EMEA:
Overview of comments received on draft guideline on Carcinogenicity Evaluation of Medicinal Products for the Treatment of HIV Infection. This overview contains the general comments ...