News
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
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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
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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
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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 ...
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. ...
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 ...
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 ...
EMEA: Guideline on Clinical Investigation of Human Normal Immunoglobulin for Intravenous Administration (IVIg)
25.03.2009
EMEA:
Guideline on Clinical Investigation of Human Normal Immunoglobulin for Intravenous Administration (IVIg). This Guideline describes the information to be documented when an ...
Guideline on Clinical Investigation of Human Normal Immunoglobulin for Intravenous Administration (IVIg). This Guideline describes the information to be documented when an ...