Remurel

Medicinal product

(Invented) name

Remurel

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

Zentiva k.s., Čekija

Date of authorisation

2016-05-10

Date of renewal

2021-03-05

Documents

3917 Remurel 20mg_ml PCS PL 2024 11 18.docx

3917 Pakuotės lapelis 2024 11 18.docx

Glatiramer acetate DHPC2024.pdf

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

NL/H/3211/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml injekcinio tirpalo (užpildytame švirkšte) 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
59703	73937	1073937	užpildytas švirkštas	1 ml N7		Receptinis	LT/1/16/3917/001	Netiekiama	-	-	No	-	-
65739	80248	1080248	užpildytas švirkštas	1 ml N28		Receptinis	LT/1/16/3917/002	Netiekiama	-	-	No	-	-	Download
65740	80249	1080249	užpildytas švirkštas	1 ml N30		Receptinis	LT/1/16/3917/003	Netiekiama	-	-	No	-	-
65741	80250	1080250	užpildytas švirkštas	1 ml N90 (3x30)		Receptinis	LT/1/16/3917/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-03-05	Perregistruotas
2016-05-10	Registruotas