European Public Assessment Reports

Approval of Marketing Authorization Assessment of the application by the Committee for Medicinal Products for Human Use (CHMP) is published initially as a Summary of Opinion—positive or negative. After the granting of a Marketing Authorization by the European Commission, a more detailed report is published as the European Public Assessment Report (EPAR). 

Establishment Inspection Report Establishment License Application enzyme linked immunosorbent assay European Medicines Agency Environmental Protection Agency European Public Assessment Report end of production cell bank erythropoietin... 

European public assessment reports, summaries of product characteristics and package leaflets may be provided to members of the public on request. 

European public assessment reports, summaries of product characteristics and package leaflets for medicines covered by Clause 21.1 above may be included on the Internet and be accessible by members of the public provided that they are not presented in such a way as to be promotional in nature. 

EPARs (European Public Assessment Reports) and Withdrawal Public Assessment Reports... 

Humira. Scientific Discussion. European Public Assessment Report. European Medicines Agency. http //www.emea.europa.eu/humandocs/Humans/EPAR/ humira/humira.htm... 

European Public Assessment Reports (EPARs) database. http //www.emea.europa. 

Source All data for this table was taken from Label, FDA Summary Basis for Approval, and EPAR (European Public Assessment Report) documents. Safety Pharmacology ICHS7. 

Commission on Proprietary Medicinal Products (CPMP). Crixivan. European Public Assessment Report. London EMEA, October 1997. 

In case of a positive opinion, between days 210 and 240, the applicant prepares the final SmPC and labeling in all the 22 required languages. Between days 240 and 300 the European Public Assessment Report (EPAR) is finalized in agreement with the applicant. The EPAR is published, after the Commission decision, on the EMEA web site. 

Before 300 Finalization of European Public Assessment Report in consultation with (Co-)Rapporteur(s), CPMP and company (for confidentiality aspects). 

European molecular biology institute 255 European nutrigenomics organization 93 European organization for the treatment of cancer (EORTC) 1233 European pharmacopoeia 1680 European public assessment report (EPAR) 1688... 

The temperature of these storage areas must be monitored and are equipped with an alarm if the temperature exceeds specified limits. If the storage temperature, is exceeded for instance because of a power failure, the pharmacist shall assess the measures to be taken. The capacity of the cold storage to withstand power outs should be known i.e. measure the rate at which the storage warms when power is switched off. Some fridge products can stand temporary storage at higher temperatures for short periods. The product information from the manufacturer (SPC and Scientific Discussion in the European Public Assessment Reports [11]) may contain such data. 

SPC and Scientific Discussion in the European Public Assessment Reports http //www.ema.europa.eu/ema/index.jsp ... 

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