Plegridy

Medicinal product

(Invented) name

Plegridy

Active substance (s)

Peginterferonas beta-1a+Peginterferonas beta-1a

Strength

63 µg + 94 µg

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)

L03AB13, Peginterferon beta-1a

Marketing authorisation holder

Biogen Netherlands B.V., Nyderlandai

Date of authorisation

2014-06-18

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
Peginterferonas beta-1a	63 µg
Solution for injection	0.5 ml
Peginterferonas beta-1a	94 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
59681	73915	1073915	užpildytas švirkštas	0,5 ml (63 µg) + 0,5 ml (94 µg) N1 (gydymo pradžiai)		Receptinis	EU/1/14/934/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-06-18	Registruotas