Fuzeon

Medicinal product

(Invented) name

Fuzeon

Active substance (s)

Enfuvirtidas

Strength

90 mg/ml

Pharmaceutical form

milteliai ir tirpiklis injekciniam tirpalui

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J05AX07, Enfuvirtide

Marketing authorisation holder

Roche Registration GmbH, Vokietija

Date of authorisation

2003-05-27

Date of renewal

Documents

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

Powder and solvent for solution for injection	1 ml
Enfuvirtidas	90 mg/ml

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
26020	28609	1028609	flakonas	milteliai, tirpiklio flakonas (2 ml), švirkštai (3 ml), švirkštai (1 ml), 2 spiritiniai tamponai N60		Receptinis	EU/1/03/252/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2003-05-27	Registruotas