Kestine

Medicinal product

(Invented) name

Kestine

Active substance (s)

Ebastinas

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)

R06AX22, Ebastine

Marketing authorisation holder

Almirall, S.A., Ispanija

Date of authorisation

1998-10-22

Date of renewal

2011-01-17

Documents

2295 Kestine 10mg II PL 2021 09 20.docx

2295 Pakuotės lapelis 10mg Rp 2021 09 20.docx

2295 Pakuotės lapelis 10mg OTC 2021 09 20.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Ebastinas	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
7664	12601	1012601	lizdinė plokštelė	N10		Nereceptinis	LT/1/98/2295/001	Netiekiama	-	-	No	-	-	Download
7665	3913	1003913	lizdinė plokštelė	N30		Receptinis	LT/1/98/2295/002	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2011-01-17	Perregistruotas
1998-10-22	Registruotas