
Regulatory19 May 2026, 06:21 pm
Zim Labs Gets Italy Nod for Dabigatran Etexilate
AI Summary
ZIM Laboratories Ltd has received Marketing Authorization (MA) from Agenzia Italiana del Farmaco (AIFA) for its anticoagulant product, Dabigatran Etexilate (75 mg, 110 mg & 150 mg hard capsules), in Italy via DCP to its wholly owned European subsidiary, SIA ZIM Laboratories Limited, Latvia. This authorization is expected to facilitate faster approvals in other European Union countries, the UK, and other global markets. Dabigatran Etexilate Capsules are used for the prevention and treatment of thromboembolic disorders. The EU market size for this product in 2025 was approximately USD 392.84 MN, with Italy contributing USD 60.91 MN.
Key Highlights
- Zim Labs secures Marketing Authorization in Italy for Dabigatran Etexilate.
- Authorization via DCP to its European subsidiary SIA ZIM Laboratories Limited.
- The product targets thromboembolic disorders, including stroke prevention.
- EU market size for Dabigatran Etexilate in 2025 was USD 392.84 MN.
- Italy's contribution to the EU market was USD 60.91 MN in 2025.
Price Impact
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