Ospamox

Medicinal product

(Invented) name

Ospamox

Active substance (s)

Amoksicilinas

Strength

250 mg/5 ml

Pharmaceutical form

milteliai geriamajai suspensijai

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J01CA04, Amoxicillin

Marketing authorisation holder

Sandoz d.d., Slovėnija

Date of authorisation

2010-01-19

Date of renewal

2013-02-28

Documents

1840 Pakuotės lapelis milt ger susp 2023 05 18.docx

1840 Ospamox milt ger susp PCS PL 2023 05 18.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

AT/H/0187/005/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

5 ml paruoštos suspensijos yra	5 ml
Amoksicilinas	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
23592	26284	1026284	buteliukas	6,6 g ir geriamasis švirkštas/matavimo šaukštas N1		Receptinis	LT/1/10/1840/021	Tiekiama	2025-03-14	-	No	-	-	Download
24438	27094	1027094	buteliukas	11 g ir geriamasis švirkštas/matavimo šaukštas N1		Receptinis	LT/1/10/1840/022	Tiekiama	2024-11-15	-	No	-	-

Stadijos

Data	Stadija
2013-02-28	Perregistruotas
2010-01-19	Registruotas