Xyzal

Medicinal product

(Invented) name

Xyzal

Active substance (s)

Levocetirizino dihidrochloridas

Strength

0,5 mg/ml

Pharmaceutical form

geriamasis tirpalas

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R06AE09, Levocetirizine

Marketing authorisation holder

UCB Pharma Oy Finland, Suomija

Date of authorisation

2007-03-01

Date of renewal

2015-01-27

Documents

0476 Xyzal geriam tirp PCS PL 2022 07 12.docx

0476 Pakuotės lapelis geriam tirp 2022 07 12.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

DE/H/0299/003/MR

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Levocetirizino dihidrochloridas	0,5 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
18816	22346	1022346	buteliukas	200 ml ir geriamasis švirkštas (10 ml) N1		Receptinis	LT/1/06/0476/019	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2015-01-27	Perregistruotas
2007-03-01	Registruotas