GRIVIX

Medicinal product

(Invented) name

GRIVIX

Active substance (s)

Dimetindeno maleatas

Strength

1 mg/g

Pharmaceutical form

gelis

Route (s) of administration

vartoti ant odos

Legal status for supply

Nereceptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

D04AA13, Dimetindene

Marketing authorisation holder

Zakłady Farmaceutyczne POLPHARMA S.A., Lenkija

Date of authorisation

2015-12-22

Date of renewal

2020-06-17

Documents

3860 Pakuotės lapelis 2021_05_14.docx

Grivix_LT_113_DC_ AR.pdf

3860 GRIVIX gelis II PZ PL 2021_05_14.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

LT/H/0113/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kiekviename grame gelio yra	1 g
Dimetindeno maleatas	1 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
60683	74972	1074972	tūbelė	5 g N1		Nereceptinis	LT/1/15/3860/001	Netiekiama	-	-	No	-	-
64655	79140	1079140	tūbelė	20 g N1		Nereceptinis	LT/1/15/3860/002	Netiekiama	-	-	No	-	-
64656	79141	1079141	tūbelė	30 g N1		Nereceptinis	LT/1/15/3860/003	Tiekiama	-	-	No	-	-	Download
64657	79142	1079142	tūbelė	50 g N1		Nereceptinis	LT/1/15/3860/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-06-17	Perregistruotas
2015-12-22	Registruotas