Rebif

Medicinal product

(Invented) name

Rebif

Active substance (s)

Interferonas beta-1a+Interferonas beta-1a

Strength

8,8 µg + 22 µg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkštiklyje

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 in pre-filled pen (0,2 ml)	0.2 ml
Interferonas beta-1a	8,8 µg
Solution for injection in pre-filled pen (0,5 ml)	0.5 ml
Interferonas beta-1a	22 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
105166	91268	1091268	užpildytas švirkštiklis	0,2 ml N6 (8,8 µg) + 0,5 ml N6 (22 µg) (DebiRose)	pakuotė gydymui pradėti	Receptinis	EU/1/98/063/017	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
1998-05-04	Registruotas