Strensiq

Medicinal product

(Invented) name

Strensiq

Active substance (s)

Asfotazė alfa

Strength

100 mg/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A16AB13, Asfotase alfa

Marketing authorisation holder

Alexion Europe SAS, Prancūzija

Date of authorisation

2015-08-28

Date of renewal

Documents

Strensiq mokomoji medziaga pacientams 2.pdf

Strensiq mokomoji medziaga pacientams.pdf

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	1 ml
Asfotazė alfa	100 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
63998	78444	1078444	flakonas	0,8 ml N1		Receptinis	EU/1/15/1015/003	Netiekiama	-	-	No	-	-
63999	78445	1078445	flakonas	0,8 ml N12		Receptinis	EU/1/15/1015/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-08-28	Registruotas