Palynziq

Medicinal product

(Invented) name

Palynziq

Active substance (s)

Pegvaliazė

Strength

20 mg

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)

A16AB19, pegvaliase

Marketing authorisation holder

BioMarin International Limited, Airija

Date of authorisation

2019-05-03

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 syringe	1 ml
Pegvaliazė	20 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
101607	87711	1087711	užpildytas švirkštas	N1		Receptinis	EU/1/19/1362/003	Netiekiama	-	-	No	-	-
101608	87712	1087712	užpildytas švirkštas	N4		Receptinis	EU/1/19/1362/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-05-03	Registruotas