COPAXONE

Medicinal product

(Invented) name

COPAXONE

Active substance (s)

Glatiramerio acetatas

Strength

20 mg/ml

Pharmaceutical form

injekcinis tirpalas užpildytame švirkšte

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L03AX13, Glatiramer acetate

Marketing authorisation holder

Teva GmbH, Vokietija

Date of authorisation

2006-12-07

Date of renewal

2008-01-17

Documents

0240 Pakuotės lapelis 20mg 2025 01 07.docx

Glatiramer acetate DHPC2024.pdf

0240 COPAXONE 20 PZ PL 2025 01 07.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

DE/H/5283/002

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Glatiramerio acetatas	20 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
19586	4651	1004651	užpildytas švirkštas	1 ml N28		Receptinis	LT/1/05/0240/002	Tiekiama	-	-	No	-	-	Download
34633	36975	1036975	užpildytas švirkštas	1 ml N7		Receptinis	LT/1/05/0240/003	Netiekiama	-	-	No	-	-
56155	70238	1070238	užpildytas švirkštas	1 ml N30		Receptinis	LT/1/05/0240/004	Netiekiama	-	-	No	-	-
56156	70239	1070239	užpildytas švirkštas	1 ml N90 (3x30) (sudėtinė)		Receptinis	LT/1/05/0240/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2008-01-17	Perregistruotas
2006-12-07	Registruotas