Zyrtec

Medicinal product

(Invented) name

Zyrtec

Active substance (s)

Cetirizino dihidrochloridas

Strength

10 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Nereceptinis/Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R06AE07, Cetirizine

Marketing authorisation holder

UCB Pharma Oy Finland, Suomija

Date of authorisation

1997-10-23

Date of renewal

2012-03-15

Documents

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

2859 pakuotes lapelis tab 10mg OTC 2023 09 22.docx

2859 pakuotes lapelis tab 10mg Rp 2023 09 22.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

IE/H/0209/001/MR

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
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
5679	10903	1010903	lizdinė plokštelė	N7		Nereceptinis	LT/1/97/2859/001	Netiekiama	-	-	No	-	-
5680	10904	1010904	lizdinė plokštelė	N10		Nereceptinis	LT/1/97/2859/002	Tiekiama	-	-	No	-	-	Download
51709	65605	1065605	lizdinė plokštelė	N30		Receptinis	LT/1/97/2859/003	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2012-03-15	Perregistruotas
1997-10-23	Registruotas