Copegus

Medicinal product

(Invented) name

Copegus

Active substance (s)

Ribavirinas

Strength

200 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

2004-07-13

Date of renewal

2007-11-30

Documents

0111 Copegus 200mg tab PCS PL 2021 08 22.docx

0111 Pakuotės lapelis 200mg 2021 08 22.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

NL/H/0352/001/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Ribavirinas	200 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
11866	16294	1016294	buteliukas	N28		Receptinis	LT/1/04/0111/001	Netiekiama	-	-	No	-	-
11867	16295	1016295	buteliukas	N42		Receptinis	LT/1/04/0111/002	Netiekiama	-	-	No	-	-
11868	16296	1016296	buteliukas	N112		Receptinis	LT/1/04/0111/003	Netiekiama	-	-	No	-	-
11869	3792	1003792	buteliukas	N168		Receptinis	LT/1/04/0111/004	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2022-05-30	Išregistruotas
2007-11-30	Perregistruotas
2004-07-13	Registruotas