Ostorep

Medicinal product

(Invented) name

Ostorep

Active substance (s)

Aceklofenakas

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)

M01AB16, Aceclofenac

Marketing authorisation holder

Medochemie Ltd., Kipras

Date of authorisation

2026-08-31

Date of renewal

Documents

6134_Ostorep.docx

6134_pakuotes lapelis_2026-08-31.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

SK/H/0347/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Aceklofenakas	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
122110	108221	1108221	lizdinė plokštelė	N20		Receptinis	LT/1/26/6134/001	Netiekiama	-	-	No	-	-
122111	108222	1108222	lizdinė plokštelė	N30		Receptinis	LT/1/26/6134/002	Netiekiama	-	-	No	-	-
122112	108223	1108223	lizdinė plokštelė	N60		Receptinis	LT/1/26/6134/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2026-08-31	Registruotas