PRODUCT DETAIL

Rovamycine 3 M.I.U.

Code

18536

MA number

15/0240/13-S

Product Form:

tbl flm 10x3 M.I.U.(blis.PVC/Al)

MA Status:

D - Marketing Authorisation valid for an unlimited period

Type of procedure:

National

MAH, country:

Sanofi Winthrop Industrie, France

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:

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_06.2023.pdf
SPC:	SPC_Rovamycine 3 M.I.U tbl flm_06.2023.pdf
Safety feature	Yes
Data update:	16.07.2018