BRAVELLE

Medicinal product

(Invented) name

BRAVELLE

Active substance (s)

Urofolitropinas

Strength

75 TV

Pharmaceutical form

milteliai ir tirpiklis injekciniam tirpalui

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

G03GA04, Urofollitropin

Marketing authorisation holder

Ferring GmbH, Vokietija

Date of authorisation

2008-12-30

Date of renewal

2014-02-26

Documents

1393_1_2 BRAVELLE milt PCS PL 161031.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

UK/H/0697/001/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Miltelius ištirpinus pakuotėje esančiame tirpiklyje, flakone yra :	1 vnt.
Urofolitropinas	75 TV

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
23580	26274	1026274	flakonas	milteliai ir ampulė tirpiklio (1 ml) N5		Receptinis	LT/1/08/1393/001	Netiekiama	-	-	No	-	-
23916	26596	1026596	flakonas	milteliai ir ampulė tirpiklio (1 ml) N10		Receptinis	LT/1/08/1393/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-08-05	Išregistruotas
2014-02-26	Perregistruotas
2008-12-30	Registruotas