Doxylamine Krka

Medicinal product

(Invented) name

Doxylamine Krka

Active substance (s)

Doksilamino-vandenilio sukcinatas

Strength

25 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R06AA09, Doxylamine

Marketing authorisation holder

KRKA, d.d., Novo mesto, Slovėnija

Date of authorisation

2018-10-08

Date of renewal

Documents

4277_01-04 Pakuotes lapelis_2018-10-08.docx

4277_01-04 Doxylamine Krka_DC.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DE/H/5227/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Doksilamino-vandenilio sukcinatas	25 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
100264	86373	1086373	lizdinė plokštelė	N7		Receptinis	LT/1/18/4277/001	Netiekiama	-	-	No	-	-
100265	86374	1086374	lizdinė plokštelė	N10		Receptinis	LT/1/18/4277/002	Netiekiama	-	-	No	-	-
100266	86375	1086375	lizdinė plokštelė	N14		Receptinis	LT/1/18/4277/003	Netiekiama	-	-	No	-	-
100267	86376	1086376	lizdinė plokštelė	N20		Receptinis	LT/1/18/4277/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-12-29	Išregistruotas
2018-10-08	Registruotas