Rovamicina

Medicinal product

(Invented) name

Rovamicina

Active substance (s)

Spiramicinas

Strength

3000000 TV

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J01FA02, Spiramycin

Marketing authorisation holder

UAB Niromed, Lietuva

Date of authorisation

2024-09-19

Date of renewal

Documents

2218_Rovamicina_3000000TV_pl_d_tab_PL_2024-09-19.docx

2218_Rovamicina_3000000TV_pl_d_tab_PZ_2024-09-19.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Lygiagretus importas

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Spiramicinas	3000000 TV

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
114937	101044	1101044	lizdinė plokštelė	N12		Receptinis	LT/L/24/2218/001	Tiekiama	2025-10-16	-	No	-	-	Download

Stadijos

Data	Stadija
2024-09-19	Registruotas