Solifenacin/Tamsulosin Newbury approved by the Norwegian Health Authorities
Newbury Pharmaceuticals is pleased to announce the Marketing Authorization (MA) of Solifenacin/Tamsulosin Newbury 6 mg/0,4 mg modified release tablets in Norway as the first country in a dual country registration procedure. Approval in Denmark is expected to follow upon finalized national review.
“The product is a fully bioequivalent version of Urizia MR Tablets, 6mg/0,4mg. Urizia is a niche product, indicated for the treatment of urinary tract symptoms associated with Benign Prostatic Hyperplasia (BPH) in men, who are not adequately responding to treatment with monotherapy. Based on this positive progress, we will proceed to launch this product, within the respective markets as soon as regulatory exclusivities and patents allow us.” Says Mr. Lars Minor, CEO of Newbury.
Benign prostatic hyperplasia (BPH), also called prostate enlargement, is a noncancerous increase in size of the prostate gland. Symptoms may include frequent urination, trouble starting to urinate, weak stream, inability to urinate, or loss of bladder control.
