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PRODUCT DETAIL

Gribero 75 mg tvrdé kapsuly

Code 4443E
MA number 16/0222/23-S
Product Form: cps dur 100(2x50x1)x75 mg (blis.OPA/Al/vysúš.PE-Al/PE-perfor.-jednodáv.-multibal.)
MA Status: R - Valid Marketing Authorisation
Type of procedure: Decentralised
MAH, country: Sandoz Pharmaceuticals d.d., Slovenia
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: 02.10.2023
Validity: 02.10.2028
Pediatric indication: Yes
Pediatric posology: Yes
Pediatric contraindication: Yes
Pediatric warnings: Yes
Dokument: dabigatran etexilát_Príručka pre predpisujúceho lekára VTE.pdf  
Dokument: dabigatran etexilát_Príručka pre predpisujúceho lekára CMP.pdf  
Dokument: dabigatran etexilát_Príručka pre predpisujúceho lekára - pediatria.pdf  
SPC: SPC_Gribero 75 mg tvrdé kapsuly_09.2024.pdf  
PIL: PIL_Gribero 75 mg tvrdé kapsuly_09.2024.pdf  
Safety feature Yes
Data update: 09.10.2023
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