Sitagliptin/Metformin hydrochloride Olpha

Medicinal product

(Invented) name

Sitagliptin/Metformin hydrochloride Olpha

Active substance (s)

Sitagliptinas/Metformino hidrochloridas

Strength

50 mg/1000 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)

A10BD07, Metformin and sitagliptin

Marketing authorisation holder

Olpha AS, Latvija

Date of authorisation

2025-11-20

Date of renewal

Documents

5894_95_Sitag_metf_HCl Olpha.docx

5894_95_pakuotes lapelis_2025-11-20.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

LV/H/0280/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Sitagliptinas	50 mg
Metformino hidrochloridas	1000 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
119154	105259	1105259	lizdinė plokštelė	N28		Receptinis	LT/1/25/5895/001	Netiekiama	-	-	No	-	-
119155	105260	1105260	lizdinė plokštelė	N56		Receptinis	LT/1/25/5895/002	Netiekiama	-	-	No	-	-
119156	105261	1105261	lizdinė plokštelė	N60		Receptinis	LT/1/25/5895/003	Netiekiama	-	-	No	-	-
119157	105262	1105262	lizdinė plokštelė	N196		Receptinis	LT/1/25/5895/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-11-20	Registruotas