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PRODUCT DETAIL

Rovamycine 1,5 M.I.U.

Code 98069
MA number 15/0090/92-S
Product Form: tbl flm 16x1,5 M.I.U.(blis.PVC/Al)
MA Status: D - Marketing Authorisation valid for an unlimited period
Type of procedure: National
Therapeutic Class: 15 - ANTIBIOTICA (PROTI MIKROB. A VÍRUSOVÝM INFEKCIAM)
ATC:
J ANTIINFECTIVES FOR SYSTEMIC USE
J01 ANTIBACTERIALS FOR SYSTEMIC USE
J01F MACROLIDES, LINCOSAMIDES AND STREPTOGRAMINS
J01FA Macrolides
J01FA02 Spiramycin
Shelf life: 36
Container: blister PVC/Al
Route of admin.: Oral use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 21.05.1992
Pediatric indication: Yes
Pediatric posology: Yes
PIL: PIL_Rovamycine 1,5 M.I.U; 3 M.I.U tbl flm_12.2021.pdf  
SPC: SPC_Rovamycine 1,5 M.I.U. tbl flm_12.2021.pdf  
Safety feature Yes
Data update: 16.07.2018
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