Rovamycine

Medicinal product

(Invented) name

Rovamycine

Active substance (s)

Spiramicinas

Strength

1,5 mln. 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 SANOFI-AVENTIS LIETUVA, Lietuva

Date of authorisation

1998-01-28

Date of renewal

2013-12-31

Documents

3485_1_2 Rovamycine tab II PL 190903.docx

3485_1_2 Pakuotės lapelis 190903.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Spiramicinas	1,5 mln. 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
5732	10948	1010948	lizdinė plokštelė	N16		Receptinis	LT/1/98/3485/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-04-29	Išregistruotas
2013-12-31	Perregistruotas
1998-01-28	Registruotas