Dacepton

Medicinal product

(Invented) name

Dacepton

Active substance (s)

Apomorfino hidrochloridas hemihidratas

Strength

10 mg/ml

Pharmaceutical form

injekcinis ar infuzinis tirpalas

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N04BC07, Apomorphine

Marketing authorisation holder

EVER Neuro Pharma GmbH, Austrija

Date of authorisation

2012-01-06

Date of renewal

Documents

2759_1_7 Dacepton 10mg_ml PCS PL keit.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Apomorfino hidrochloridas hemihidratas	10 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
38329	51985	1051985	ampulė	N5x1		Receptinis	LT/1/11/2759/001	Netiekiama	-	-	No	-	-
50686	64574	1064574	ampulė	N10x1		Receptinis	LT/1/11/2759/002	Netiekiama	-	-	No	-	-
50687	64575	1064575	ampulė	N2x5		Receptinis	LT/1/11/2759/003	Netiekiama	-	-	No	-	-
50688	64576	1064576	ampulė	N5x5		Receptinis	LT/1/11/2759/004	Netiekiama	-	-	No	-	-
50689	64577	1064577	ampulė	N10x5		Receptinis	LT/1/11/2759/005	Netiekiama	-	-	No	-	-
50690	64578	1064578	ampulė	N3x10		Receptinis	LT/1/11/2759/006	Netiekiama	-	-	No	-	-
50691	64579	1064579	ampulė	N10x10		Receptinis	LT/1/11/2759/007	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-03-23	Išregistruotas
2012-01-06	Registruotas