Enbrel

Medicinal product

(Invented) name

Enbrel

Active substance (s)

Etanerceptas

Strength

25 mg

Pharmaceutical form

injekcinis tirpalas dozės skaičiuoklio užtaise

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L04AB01, Etanercept

Marketing authorisation holder

Pfizer Europe MA EEIG, Belgija

Date of authorisation

2001-12-17

Date of renewal

Documents

Enbrel paciento kortele.pdf

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for injection in dose-dispenser cartridge	0.5 ml
Etanerceptas	25 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
108540	94644	1094644	dozės skaičiuoklio užtaisas	N4 (ir 8 tamponai)		Receptinis	EU/1/99/126/027	Netiekiama	-	-	No	-	-
108541	94645	1094645	dozės skaičiuoklio užtaisas	N8 (ir 16 tamponų)		Receptinis	EU/1/99/126/028	Netiekiama	-	-	No	-	-
108542	94646	1094646	dozės skaičiuoklio užtaisas	N24 (ir 48 tamponai)		Receptinis	EU/1/99/126/029	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2001-12-17	Registruotas