Sitagliptin Olpha

Medicinal product

(Invented) name

Sitagliptin Olpha

Active substance (s)

Sitagliptinas

Strength

100 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A10BH01, Sitagliptin

Marketing authorisation holder

Olpha AS, Latvija

Date of authorisation

2025-02-14

Date of renewal

Documents

5703-04-05_Sitagliptin Olpha_corrPZ.docx

5703-05_pakuotes lapelis_2025-02-14.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

MT/H/0709/003/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Sitagliptinas	100 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
116636	102735	1102735	lizdinė plokštelė	N28		Receptinis	LT/1/25/5705/001	Netiekiama	-	2025-11-17	No	-	-
116637	102736	1102736	lizdinė plokštelė	N30		Receptinis	LT/1/25/5705/002	Netiekiama	-	-	No	-	-
116638	102737	1102737	lizdinė plokštelė	N56		Receptinis	LT/1/25/5705/003	Netiekiama	-	-	No	-	-
116639	102738	1102738	lizdinė plokštelė	N98		Receptinis	LT/1/25/5705/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-02-14	Registruotas