Fromilid

Medicinal product

(Invented) name

Fromilid

Active substance (s)

Klaritromicinas

Strength

125 mg/5 ml

Pharmaceutical form

granulės geriamajai suspensijai

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J01FA09, Clarithromycin

Marketing authorisation holder

KRKA, d.d., Novo mesto, Slovėnija

Date of authorisation

2000-01-28

Date of renewal

2009-07-21

Documents

1613_1 Pakuotės lapelis 210420.docx

1613_1_2 Fromilid gran ger susp PCS PL 210420.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

5 ml suspensijos yra	5 ml
Klaritromicinas	125 mg

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
535	3031	1003031	buteliukas	60 ml ir geriamasis švirkštas (5 ml) N1		Receptinis	LT/1/97/1613/001	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2009-07-21	Perregistruotas
2000-01-28	Registruotas