Britaject

Medicinal product

(Invented) name

Britaject

Active substance (s)

Apomorfino hidrochloridas

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

STADA Arzneimittel AG, Vokietija

Date of authorisation

2012-04-27

Date of renewal

2022-06-21

Documents

2917 Pakuotės lapelis amp 2023 12 21.docx

2917 Britaject inj_inf amp PCS PL 2023 12 21.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

IE/H/0658/002

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Apomorfino hidrochloridas	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
44561	58357	1058357	ampulė	2 ml N1		Receptinis	LT/1/12/2917/001	Netiekiama	-	-	No	-	-
44562	58358	1058358	ampulė	2 ml N25		Receptinis	LT/1/12/2917/002	Netiekiama	-	-	No	-	-
52192	66111	1066111	ampulė	2 ml N50		Receptinis	LT/1/12/2917/003	Netiekiama	-	-	No	-	-
52193	66112	1066112	ampulė	5 ml N5		Receptinis	LT/1/12/2917/004	Netiekiama	-	-	No	-	-
52194	66113	1066113	ampulė	5 ml N25		Receptinis	LT/1/12/2917/005	Netiekiama	-	-	No	-	-
52195	66114	1066114	ampulė	5 ml N50		Receptinis	LT/1/12/2917/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-07-31	Išregistruotas
2022-06-21	Perregistruotas
2012-04-27	Registruotas