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PRODUCT DETAIL

Eltrombopag Glenmark 12,5 mg

Code 6616E
MA number 16/0156/24-S
Product Form: tbl flm 30x12,5 mg (blis.OPA/Al/PVC/Al)
MA Status: R - Valid Marketing Authorisation
Type of procedure: Decentralised
MAH, country: Glenmark Pharmaceuticals s.r.o., Czechia
Therapeutic Class: 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.)
ATC:
B BLOOD AND BLOOD FORMING ORGANS
B02 ANTIHEMORRHAGICS
B02B LOCAL HEMOSTATICS, COMBINATIONS
B02BX Other systemic hemostatics
B02BX05 Eltrombopag
Shelf life: 24
Container: blister OPA/Al/PVC/Al
Route of admin.: Oral use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 10(1) generic application
MA issued: 27.06.2024
Validity: 27.06.2029
Pediatric indication: Yes
Pediatric posology: Yes
Pediatric warnings: Yes
PIL: PIL_Eltrombopag Glenmark_06.2024.pdf  
SPC: SPC_Eltrombopag Glenmark_06.2024.pdf  
Safety feature Yes
Data update: 02.07.2024
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