BROMHEXINE-GRINDEKS

Medicinal product

(Invented) name

BROMHEXINE-GRINDEKS

Active substance (s)

Bromheksinas

Strength

4 mg/5 ml

Pharmaceutical form

sirupas

Route (s) of administration

vartoti per burną

Legal status for supply

Nereceptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R05CB02, Bromhexine

Marketing authorisation holder

AS Grindeks, Latvija

Date of authorisation

1996-05-17

Date of renewal

2011-04-29

Documents

1714 Pakuotės lapelis sirupas 2024 10 16, VRA_19535.docx

1714 BROMHEXINE_GRINDEKS sirupas PL 2024 10 16, VRA_19535.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

5 ml sirupo yra	5 ml
Bromheksinas	4 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
3287	8770	1008770	buteliukas	100 ml ir matavimo šaukštas N1		Nereceptinis	LT/1/97/1714/003	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2011-04-29	Perregistruotas
1996-05-17	Registruotas