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PRODUCT DETAIL

Dabigatran etexilate STADA 150 mg tvrdé kapsuly

Code 6830E
MA number 16/0170/24-S
Product Form: cps dur 30x150 mg (blis. OPA/Al/vysúšadlo PE-Al/PE)
MA Status: R - Valid Marketing Authorisation
Type of procedure: Decentralised
MAH, country: STADA Arzneimittel AG, Germany
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: 36
Route of admin.: Oral use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 10(1) generic application
MA issued: 06.08.2024
Validity: 06.08.2029
Pediatric indication: Yes
Pediatric posology: Yes
Pediatric contraindication: Yes
Pediatric warnings: Yes
SPC: SPC_Dabigatran etexilate STADA 150 mg tvrdé kapsuly_07 2024.pdf  
PIL: PIL_Dabigatran etexilate STADA 150 mg tvrdé kapsuly_07 2024.pdf  
Safety feature Yes
Data update: 23.08.2024
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