Adalvo is happy to announce that following the successful compilation of all necessary requirements today we submitted our Solifenacin+Tamsulosin MR Tablet dossier and will proceed via several DCP procedures in Europe. Our product is Solifenacin+Tamsulosin 6+0.4mg MR Tablet that has been developed based on the reference brand Vesomni® (Astellas) 6+ 0.4mg MR Tablets. Adalvo product has been co-developed with one of our strategic partner.
We expect Adalvo to be among the first companies getting an approval and launching the product in EU.
Solifenacin+Tamsulosin is a combination medication that is used in the treatment of benign prostatic hyperplasia. The brand has been selling $75 million across the globe in 2020 according to IQVIA.
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Disclaimer: Solifenacin+Tamsulosin which is subject to patent protection is currently not offered or made available in countries where patents are in force.