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PRODUCT DETAIL

Vocasept 8,75 mg tvrdé pastilky

Code 3584E
MA number 69/0087/23-S
Product Form: pas ord 16x8,75 mg (blis.PVC/PVDC/Al)
MA Status: R - Valid Marketing Authorisation
Type of procedure: Decentralised
MAH, country: MAPAEX CONSUMER HEALTHCARE (IRELAND) PRIVATE LIMITED, Ireland
Therapeutic Class: 69 - OTORHINOLARYNGOLOGICA
ATC:
R RESPIRATORY SYSTEM
R02 THROAT PREPARATIONS
R02A THROAT PREPARATIONS
R02AX Other throut preparations
R02AX01 Flurbiprofen
Shelf life: 36
Container: blister PVC/PVDC/Al
Route of admin.: Oromucosal use
Prescription Status: Medicinal product not subject to medical prescription.
Legal basis: Article 10a well-established use application
MA issued: 31.05.2023
Validity: 31.05.2028
Pediatric indication: Yes
Pediatric posology: Yes
Dokument: VHS_SK_H_0280_001_DC_Vocasept_EPAR.DOC  
Dokument: VHS_SK_H_0280_001_DC_Vocasept_summary EPAR.doc  
PIL: PIL_Vocasept_01/2024.pdf  
SPC: SPC_Vocasept_01/2024.pdf  
Safety feature No
Data update: 31.05.2023
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