Tamsulosin, an alpha-1 adrenergic receptor blocker, combined with Dutasteride, a dual 5- alpha-reductase inhibitor, is indicated for the treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH) in adult men
The company's decision to withdraw the MAA was due to the timing of the availability of Chemistry Manufacturing and Controls
Dimethyl Fumarate Modified Release Capsules are indicated for the treatment of relapsing forms of multiple sclerosis
According to IQVIA, the European market for Buprenorphine-based opioid dependency treatments in 2023 surpassed USD 355 million annually
Relonchem Limited has received Marketing Authorization for the product Levonorgestrel 1.5 mg Tablets from UK MHRA
NULIBRY is a first-in-class synthetic cPMP substrate replacement therapy to reduce the risk of mortality in patients with MoCD Type A
These approvals mark significant progress for Venus Remedies in expanding its market presence
Trastuzumab biosimilar is a humanized monoclonal antibody for treating metastatic breast cancer
Marketing Authorization replaces conditional Marketing Authorization and is first for Novavax in the EU
This request for withdrawal of the two dossiers was made after necessary consultations and receiving guidance from EMA
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