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PRODUCT DETAIL

Dabigatran etexilate Glenmark 110 mg tvrdé kapsuly

Code 5536E
MA number 16/0024/24-S
Product Form: cps dur 180(3x60)x1x110 mg (blisAl/Al + vysúšadlo - jednotk.bal. - multibal.)
MA Status: R - Valid Marketing Authorisation
Type of procedure: Mutual recognition procedure
Therapeutic Class: 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.)
ATC:
B BLOOD AND BLOOD FORMING ORGANS
B01 ANTITHROMBOTIC AGENTS
B01A ANTITHROMBOTIC AGENTS
B01AE DIRECT THROMBIN INHIBITORS
B01AE07 Dabigatran etexilate
Shelf life: 24
Route of admin.: Oral use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 10(1) generic application
MA issued: 20.02.2024
Validity: 20.02.2029
Pediatric indication: Yes
Pediatric posology: Yes
Pediatric contraindication: Yes
Pediatric warnings: Yes
PIL: PIL_Dabigatran etexilate Glenmark 110mg_02.2024.pdf  
SPC: SPC_Dabigatran etexilate Glenmark 110 mg_02.2024.pdf  
Safety feature Yes
Data update: 22.02.2024
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