Copegus

Medicinal product

(Invented) name

Copegus

Active substance (s)

Ribavirinas

Strength

400 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)

J05AP01, ribavirin

Marketing authorisation holder

UAB Roche Lietuva, Lietuva

Date of authorisation

2007-01-26

Date of renewal

2007-11-30

Documents

0111 Pakuotės lapelis 400mg 2021 08 22.docx

0111 Copegus 400mg tab PCS PL 2021 08 22.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

NL/H/0352/002/MR

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Ribavirinas	400 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
19227	22591	1022591	buteliukas	N14		Receptinis	LT/1/04/0111/005	Netiekiama	-	-	No	-	-
19228	22592	1022592	buteliukas	N56		Receptinis	LT/1/04/0111/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-05-30	Išregistruotas
2007-11-30	Perregistruotas
2007-01-26	Registruotas