AZALONUM

Medicinal product

(Invented) name

AZALONUM

Active substance (s)

Cinarizinas/Dimenhidrinatas

Strength

20 mg/40 mg

Pharmaceutical form

tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N07CA52, Cinnarizine, combinations

Marketing authorisation holder

Medochemie Ltd., Kipras

Date of authorisation

2019-04-30

Date of renewal

2024-05-21

Documents

4373_pakuotes lapelis_2024-05-21.docx

4373_Azalonum_perr2024-05-21.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

SE/H/1798/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Cinarizinas	20 mg
Dimenhidrinatas	40 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
101473	87576	1087576	lizdinė plokštelė	N20		Receptinis	LT/1/19/4373/001	Netiekiama	-	-	No	-	-
101474	87577	1087577	lizdinė plokštelė	N30		Receptinis	LT/1/19/4373/002	Netiekiama	-	-	No	-	-
101475	87578	1087578	lizdinė plokštelė	N50		Receptinis	LT/1/19/4373/003	Tiekiama	-	-	No	-	-
101476	87579	1087579	lizdinė plokštelė	N100		Receptinis	LT/1/19/4373/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-05-21	Perregistruotas
2019-04-30	Registruotas