Community monographs and list entries serve as preferred references which contain details for the
Summary of Product Characteristics (SPC).
Marketing authorisation holders of generic medicinal products sometimes remove information from the
summary of product characteristics (SmPC) and the patient information leaflet to prevent the potential infringement of a use patent.
As in other applications, minimum, maximum and average temperatures can be collected for specific burgers or the field of view as a whole, This data can then be used for trending and
summary of product characteristics (SPC) purposes.
The new label with an updated
summary of product characteristics (SmPC) will be implemented after the EC has approved the recommendation.
(2.)
Summary of product characteristics; Diamox[R] Tablets 250mg, Goldshield plc.
It also includes the new local practice recommendations, which may differ from advice in the
summary of product characteristics. Although the information in the medicine monographs is aimed at adult patients, information to support administration to children has been included for certain medicines.
* It has released a guideline for achieving better pharmacovigilance in relation to vaccines against infectious diseases, calling on market authorisation holders to weigh the risks of vaccines against the benefits--http://www.emea.europa.eu/pdfs/human/phvwp/50344907enfin.pdf; Meanwhile, the European Commission has revised its guideline for submitting '
summary of product characteristics' (SmPC) reports in marketing applications, which will come into effect May 2010--http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol- 2/c/smpc_guideline_rev2.pdf.
It also sets out the possibility, in the event of an extension to the MA, of a full and distinct authorisation demand for a medicine that has already been authorised, but under a different denomination and with a different
summary of product characteristics. Grossetete justified this principle by the fact that "some medicine names are strongly associated with a pathology and being obliged to keep the same name for another completely different pathology could have a damaging effect for the patient".
The announcement results from the European Commission's decision to harmonize the
summary of product characteristics (SPC) for Prograf across all EU member countries.
Britannia Pharmaceuticals, the manufacturer of lofexidine (BritLofex), has added a warning about adverse ECG changes to its
summary of product characteristics. "Before initiating lofexidine, clinicians may want to screen patients who might be at risk for repolarization abnormalities," the researchers noted.
At the completion of the MRP, the following countries have endorsed the mutually agreed
summary of product characteristics: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Iceland, Italy, Luxemburg, Netherlands, Norway, Portugal, Spain, Sweden and the United Kingdom.