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Registerpharmacological alternative [Regulatives / Guidelines]
Dear all
We have a active substance which is a pharmacological alternative (different salt) of an already approved drug in Europe. But our salt is approved in other countries. In this scenario,if we prove Bioequivalence of ours with reference available in Europe, can we register the dossier in Europe?
We have a active substance which is a pharmacological alternative (different salt) of an already approved drug in Europe. But our salt is approved in other countries. In this scenario,if we prove Bioequivalence of ours with reference available in Europe, can we register the dossier in Europe?
Complete thread:
- pharmacological alternativevelupharm 2007-03-29 14:34
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- pharmacological alternative Ohlbe 2007-03-29 16:10
- pharmacological alternative velupharm 2007-03-29 17:53
- pharmacological alternative Ohlbe 2007-03-29 16:10
Ing. Helmut Schütz