Betahistine Actavis

Medicinal product

(Invented) name

Betahistine Actavis

Active substance (s)

Betahistino dihidrochloridas

Strength

8 mg

Pharmaceutical form

tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N07CA01, Betahistine

Marketing authorisation holder

Actavis Group hf., Islandija

Date of authorisation

2006-10-12

Date of renewal

2012-09-07

Documents

0570_1_10 Betahistine Actavis II PL 160812.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/0710/001/MR

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Betahistino dihidrochloridas	8 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
19231	22595	1022595	lizdinė plokštelė	N50		Receptinis	LT/1/06/0570/001	Netiekiama	-	-	No	-	-
20496	23492	1023492	lizdinė plokštelė	N100		Receptinis	LT/1/06/0570/002	Netiekiama	-	-	No	-	-
20497	23493	1023493	lizdinė plokštelė	N120		Receptinis	LT/1/06/0570/003	Netiekiama	-	-	No	-	-
27413	29968	1029968	lizdinė plokštelė	N30		Receptinis	LT/1/06/0570/009	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-12-05	Išregistruotas
2012-09-07	Perregistruotas
2006-10-12	Registruotas