Britaject

Medicinal product

(Invented) name

Britaject

Active substance (s)

Apomorfino hidrochloridas hemihidratas

Strength

5 mg/ml

Pharmaceutical form

infuzinis tirpalas užtaise

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

2026-03-30

Date of renewal

Documents

5988_pakuotes lapelis_2026-03-30.docx

5988_Britaject.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

IE/H/0658/004/E/001

Marketing authorisation procedure

Kartotinė 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
120370	106474	1106474	užtaisas	20 ml N5		Receptinis	LT/1/26/5988/001	Netiekiama	-	-	No	-	-
120371	106475	1106475	užtaisas	20 ml N25 (5×5)		Receptinis	LT/1/26/5988/002	Netiekiama	-	-	No	-	-
120372	106476	1106476	užtaisas	20 ml N50 (10×5)		Receptinis	LT/1/26/5988/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2026-03-30	Registruotas