Fromilid

Medicinal product

(Invented) name

Fromilid

Active substance (s)

Klaritromicinas

Strength

250 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

2009-07-21

Date of renewal

2014-06-06

Documents

1613_2 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	250 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
17594	21398	1021398	buteliukas	60 ml ir geriamasis švirkštas (5 ml) N1		Receptinis	LT/1/97/1613/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-06-06	Perregistruotas
2009-07-21	Registruotas