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Four female clusters have been identified.The majority of women who fell into Cluster One which was characterized by storage problems, such as need to go to the toilet frequently and getting up to go at night. They had a total of fewer symptoms than women in the other clusters.Two studies have provided information to the patient-relevant endpoint to the mortality as well symptoms of shortness of breath breathlessness have, of supplemental oxygen and physical loading capacity. Results the results of health-related life quality and side effects . Minor additional benefit and major damage with not – serious consequences. Overall assessment compares the advantages and disadvantages.

The manufacturers must submit documentation for Orphan Medicinal Products.

The statutory instrument pursuant the early benefit evaluation are 6 categories on the extent of the additional benefit: When an added benefit is determined that it was large is significant or minor induced, depending on the extent of improvement out of of the drug. When added to benefit, but on available data estimated on the basis of available data, this is seen as non-quantifiable . May be assess to the benefit of the medication as smaller than the efit of the respective comparator therapy . When no additional benefit on the basis of which file can be prepared the manufacturer, the Regulation sets the category no proven added benefit .