Business Milestones
2025.11.27
TAHO Pharmaceuticals Announces European Medicines Agency (EMA) Validation of Marketing Authorization Application for BEQIA(TAH3311), the world’s first Apixaban Oral Dissolving Film (ODF)
TAHO Pharmaceuticals Announces European Medicines Agency (EMA) Validation of Marketing Authorization Application for BEQIA(TAH3311), the world’s first Apixaban Oral Dissolving Film (ODF)
TAIPEI, TAIWAN – November 27, 2025 – TAHO Pharmaceuticals Ltd. (“TAHO Pharma”) today announced that the European Medicines Agency (EMA) has validated its Marketing Authorization Application (MAA) for BEQIA(TAH3311, Apixaban Oral Dissolving Film(ODF)), indicated for the prophylaxis of stroke, deep vein thrombosis (DVT), and pulmonary embolism (PE).
The EMA’s validation confirms that the MAA submission is complete and that the formal scientific assessment by the Committee for Medicinal Products for Human Use (CHMP), under the centralized procedure, has officially commenced. The centralized procedure enables a single marketing authorization valid across all European Union (EU) Member States, as well as Iceland, Liechtenstein, and Norway.
As part of the MAA review procedure, the CHMP will evaluate the quality and safety of BEQIA based on comprehensive clinical and non-clinical data. The MAA review timeline typically follows a standard 210-day evaluation period, which may be extended if additional information or clarification is requested by the EMA.
The EMA’s acceptance of the BEQIA application represents a significant regulatory milestone, bringing TAHO Pharma one step closer to delivering a new treatment option for patients in Europe who require daily anticoagulant therapy. TAHO remains committed to collaborating closely and efficiently with the CHMP throughout the review process.
A CHMP opinion on the MAA is expected by the end of 2026, following completion of the standard review cycle.
About Apixaban
Apixaban (co-developed by Bristol Myers Squibb and Pfizer under the brand name Eliquis®) is a direct Factor Xa inhibitor approved for several thromboembolic disorders, including stroke prevention in non-valvular atrial fibrillation, thromboprophylaxis following hip or knee replacement surgery, and the treatment and prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE). With notable safety advantages, Apixaban is recognized as a leading novel oral anticoagulant (NOAC) globally.
About TAHO Pharmaceuticals Ltd.
Founded in 2010, TAHO Pharma is a global small-to-medium enterprise (SME) specializing in innovative oral and transdermal drug delivery systems. Through its proprietary Transepithelial Delivery System (TDS) platform, TAHO enables efficient transdermal and transmucosal delivery of small-molecule drugs. The TDS platform provides significant advantages over conventional delivery routes, including tailored release profiles (from rapid onset to sustained delivery), reduced gastrointestinal side effects, enhanced bioavailability, and simplified administration for patients with compliance challenges. With TAHO’s scientifically differentiated technology and clinically meaningful solutions, TAHO is dedicated to advancing patient care and improving quality of life worldwide.
Media Contact:
TAHO Pharmaceuticals
+886-2-2659-8515
ir@tahopharma.com
TAIPEI, TAIWAN – November 27, 2025 – TAHO Pharmaceuticals Ltd. (“TAHO Pharma”) today announced that the European Medicines Agency (EMA) has validated its Marketing Authorization Application (MAA) for BEQIA(TAH3311, Apixaban Oral Dissolving Film(ODF)), indicated for the prophylaxis of stroke, deep vein thrombosis (DVT), and pulmonary embolism (PE).
The EMA’s validation confirms that the MAA submission is complete and that the formal scientific assessment by the Committee for Medicinal Products for Human Use (CHMP), under the centralized procedure, has officially commenced. The centralized procedure enables a single marketing authorization valid across all European Union (EU) Member States, as well as Iceland, Liechtenstein, and Norway.
As part of the MAA review procedure, the CHMP will evaluate the quality and safety of BEQIA based on comprehensive clinical and non-clinical data. The MAA review timeline typically follows a standard 210-day evaluation period, which may be extended if additional information or clarification is requested by the EMA.
The EMA’s acceptance of the BEQIA application represents a significant regulatory milestone, bringing TAHO Pharma one step closer to delivering a new treatment option for patients in Europe who require daily anticoagulant therapy. TAHO remains committed to collaborating closely and efficiently with the CHMP throughout the review process.
A CHMP opinion on the MAA is expected by the end of 2026, following completion of the standard review cycle.
About Apixaban
Apixaban (co-developed by Bristol Myers Squibb and Pfizer under the brand name Eliquis®) is a direct Factor Xa inhibitor approved for several thromboembolic disorders, including stroke prevention in non-valvular atrial fibrillation, thromboprophylaxis following hip or knee replacement surgery, and the treatment and prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE). With notable safety advantages, Apixaban is recognized as a leading novel oral anticoagulant (NOAC) globally.
About TAHO Pharmaceuticals Ltd.
Founded in 2010, TAHO Pharma is a global small-to-medium enterprise (SME) specializing in innovative oral and transdermal drug delivery systems. Through its proprietary Transepithelial Delivery System (TDS) platform, TAHO enables efficient transdermal and transmucosal delivery of small-molecule drugs. The TDS platform provides significant advantages over conventional delivery routes, including tailored release profiles (from rapid onset to sustained delivery), reduced gastrointestinal side effects, enhanced bioavailability, and simplified administration for patients with compliance challenges. With TAHO’s scientifically differentiated technology and clinically meaningful solutions, TAHO is dedicated to advancing patient care and improving quality of life worldwide.
Media Contact:
TAHO Pharmaceuticals
+886-2-2659-8515
ir@tahopharma.com