Xiapex

Medicinal product

(Invented) name

Xiapex

Active substance (s)

Clostridium histolyticum kolagenazė

Strength

0,9 mg

Pharmaceutical form

milteliai ir tirpiklis injekciniam tirpalui

Route (s) of administration

vartoti į pažeistą vietą

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

M09AB02, Collagenase clostridium histolyticum

Marketing authorisation holder

Swedish Orphan Biovitrum AB (publ), Švedija

Date of authorisation

2011-02-28

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Powder and solvent for solution for injection	1 vnt.
Clostridium histolyticum kolagenazė	0,9 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
45466	59266	1059266	flakonas	N1+1		Receptinis	EU/1/11/671/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-12-05	Išregistruotas
2011-02-28	Registruotas