COPAXONE

Medicinal product

(Invented) name

COPAXONE

Active substance (s)

Glatiramerio acetatas

Strength

40 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

2014-12-23

Date of renewal

2019-11-22

Documents

0240 COPAXONE 40 PCS PL 2025 01 07, KR_1266.docx

0240 Pakuotės lapelis 40mg 2025 01 07, KR_1266.docx

Glatiramer acetate DHPC2024.pdf

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

DE/H/5283/004

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Glatiramerio acetatas	40 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
56298	70394	1070394	užpildytas švirkštas	1 ml N3		Receptinis	LT/1/05/0240/006	Netiekiama	-	-	No	-	-
61003	75312	1075312	užpildytas švirkštas	1 ml N12		Receptinis	LT/1/05/0240/007	Tiekiama	-	-	No	-	-	Download
61004	75313	1075313	užpildytas švirkštas	1 ml N36 (3x12) (sudėtinė)		Receptinis	LT/1/05/0240/008	Netiekiama	-	-	No	-	-
107270	93374	1093374	užpildytas švirkštas	1 ml N36		Receptinis	LT/1/05/0240/009	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-11-22	Perregistruotas
2014-12-23	Registruotas