Remurel

Medicinal product

(Invented) name

Remurel

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

Zentiva k.s., Čekija

Date of authorisation

2017-11-13

Date of renewal

2023-05-29

Documents

4164 Remurel 40 PCS PL 2025 03 19.docx

4164 Pakuotės lapelis 2025 03 19.docx

Glatiramer acetate DHPC2024.pdf

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

NL/H/3778/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Užpildytame švirkšte (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
98323	84425	1084425	užpildytas švirkštas	1 ml N3		Receptinis	LT/1/17/4164/001	Netiekiama	-	-	No	-	-
98324	84426	1084426	užpildytas švirkštas	1 ml N12		Receptinis	LT/1/17/4164/002	Tiekiama	2025-11-01	-	No	-	-	Download
98325	84427	1084427	užpildytas švirkštas	1 ml N36 (3x12)		Receptinis	LT/1/17/4164/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-05-29	Perregistruotas
2017-11-13	Registruotas