Xanderla

Medicinal product

(Invented) name

Xanderla

Active substance (s)

Goserelinas

Strength

3,6 mg

Pharmaceutical form

implantas užpildytame švirkšte

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L02AE03, Goserelin

Marketing authorisation holder

Teva B.V., Nyderlandai

Date of authorisation

2017-07-10

Date of renewal

Documents

4107_1_3 Xanderla PZ 171006.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

PT/H/1634/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Viename implante yra	1 vnt.
Goserelinas	3,6 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
68805	83388	1083388	užpildytas švirkštas	N1		Receptinis	LT/1/17/4107/001	Netiekiama	-	-	No	-	-
68806	83389	1083389	užpildytas švirkštas	N2		Receptinis	LT/1/17/4107/002	Netiekiama	-	-	No	-	-
68807	83390	1083390	užpildytas švirkštas	N3		Receptinis	LT/1/17/4107/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-12-05	Išregistruotas
2017-07-10	Registruotas