Betaserc

Medicinal product

(Invented) name

Betaserc

Active substance (s)

Betahistino dihidrochloridas

Strength

24 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

Viatris SIA, Latvija

Date of authorisation

2003-11-11

Date of renewal

2012-03-27

Documents

0848 Betaserc RPP2023 09 01.docx

0848 Pakuotės lapelis 2023 09 01.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.
Betahistino dihidrochloridas	24 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
11121	15627	1015627	lizdinė plokštelė	N20		Receptinis	LT/1/95/0848/003	Netiekiama	-	-	No	-	-
11122	15628	1015628	lizdinė plokštelė	N50		Receptinis	LT/1/95/0848/004	Tiekiama	-	-	No	-	-	Download
11123	15629	1015629	lizdinė plokštelė	N100		Receptinis	LT/1/95/0848/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2012-03-27	Perregistruotas
2003-11-11	Registruotas