Dacepton

Medicinal product

(Invented) name

Dacepton

Active substance (s)

Apomorfino hidrochloridas hemihidratas

Strength

5 mg/ml

Pharmaceutical form

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

2014-02-26

Date of renewal

2019-01-25

Documents

2759 Dacepton PCS PL 2024 02 23.docx

2759 Pakuotės lapelis 2024 02 23.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

AT/H/0364/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra:	1 ml
Apomorfino hidrochloridas hemihidratas	5 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
54366	68361	1068361	flakonas	20 ml N1		Receptinis	LT/1/11/2759/008	Netiekiama	-	-	No	-	-
58611	72794	1072794	flakonas	20 ml N5		Receptinis	LT/1/11/2759/009	Netiekiama	-	-	No	-	-
58612	72795	1072795	flakonas	20 ml N5x1 (sudėtinė)		Receptinis	LT/1/11/2759/010	Netiekiama	-	-	No	-	-
58613	72796	1072796	flakonas	20 ml N10x1 (sudėtinė)		Receptinis	LT/1/11/2759/011	Netiekiama	-	-	No	-	-
58614	72797	1072797	flakonas	20 ml N30x1 (sudėtinė)		Receptinis	LT/1/11/2759/012	Netiekiama	-	-	No	-	-
58615	72798	1072798	flakonas	20 ml N2x5 (sudėtinė)		Receptinis	LT/1/11/2759/013	Netiekiama	-	-	No	-	-
58616	72799	1072799	flakonas	20 ml N6x5 (sudėtinė)		Receptinis	LT/1/11/2759/014	Netiekiama	-	-	No	-	-
67292	81841	1081841	flakonas	20 ml N30		Receptinis	LT/1/11/2759/015	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-01-25	Perregistruotas
2014-02-26	Registruotas