Zyrtec

Medicinal product

(Invented) name

Zyrtec

Active substance (s)

Cetirizino dihidrochloridas

Strength

10 mg/ml

Pharmaceutical form

geriamieji lašai (tirpalas)

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R06AE07, Cetirizine

Marketing authorisation holder

UCB Pharma Oy Finland, Suomija

Date of authorisation

1997-11-24

Date of renewal

2012-03-15

Documents

2859 Pakuotės lapelis geriam lasai 2023 09 22.docx

2859 Zyrtec tab PCS 2022 06 13, lasai, tirp PCS 2023 09 22, PL 2023 09 22.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

IE/H/0209/002/MR

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

Viename ml tirpalo yra	1 ml
Cetirizino dihidrochloridas	10 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
5678	3218	1003218	buteliukas	20 ml su lašintuvu N1		Receptinis	LT/1/97/2859/005	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2012-03-15	Perregistruotas
1997-11-24	Registruotas