Rebif

Medicinal product

(Invented) name

Rebif

Active substance (s)

Interferonas beta-1a

Strength

44 µg

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L03AB07, Interferon beta-1a

Marketing authorisation holder

Merck Europe B.V., Nyderlandai

Date of authorisation

1998-05-04

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

Solution for injection	0.5 ml
Interferonas beta-1a	44 µg

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
1104	6944	1006944	užpildytas švirkštas	0,5 ml N1		Receptinis	EU/1/98/063/004	Netiekiama	-	-	No	-	-
1105	6945	1006945	užpildytas švirkštas	0,5 ml N3		Receptinis	EU/1/98/063/005	Netiekiama	-	-	No	-	-
1106	4423	1004423	užpildytas švirkštas	0,5 ml N12		Receptinis	EU/1/98/063/006	Tiekiama	-	-	No	-	-
34343	5538	1005538	užtaisas	1,5 ml N4		Receptinis	EU/1/98/063/009	Tiekiama	-	-	No	-	-
57691	71810	1071810	užtaisas	1,5 ml N12		Receptinis	EU/1/98/063/019	Netiekiama	-	-	No	-	-
98879	84983	1084983	užpildytas švirkštas	0,5 ml N36		Receptinis	EU/1/98/063/021	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
1998-05-04	Registruotas