Yes, EMA is the European Medicines Agency. Before the establishment of EMA, drug approvals in Europe were done at national level (individually). Post EMA, manufacturers now submit one application (to EMA), for marketing in the whole of the block. There is nothing to suggest that an EMA approval would have been harder to secure if the company had sought it. In fact, success in France gave them access to several other countries under a pre-EMA arrangement that allowed mutual recognitions. It seems the company did not pursue marketing beyond what they managed, presumably due to whatever led to the drug's discontinuation that time.
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