Xelpek

Medicinal product

(Invented) name

Xelpek

Active substance (s)

Pregabalinas

Strength

82,5 mg

Pharmaceutical form

pailginto atpalaidavimo tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

Yes

ATC code (s)

N02BF02, Pregabalin

Marketing authorisation holder

UAB Exeltis Baltics, Lietuva

Date of authorisation

2026-10-15

Date of renewal

Documents

6169-70-71_pakuotes lapelis_2026-10-15.docx

6169-70-71_Xelpex.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

NL/H/5675/001/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Pregabalinas	82,5 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
122574	108684	1108684	lizdinė plokštelė	N30		Receptinis	LT/1/26/6169/001	Netiekiama	-	-	No	-	-
122575	108685	1108685	talpyklė	N30		Receptinis	LT/1/26/6169/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2026-10-15	Registruotas