Raplixa

Medicinal product

(Invented) name

Raplixa

Active substance (s)

Žmogaus fibrinogenas/Žmogaus trombinas

Strength

79 mg/726 TV/g

Pharmaceutical form

audinių klijų milteliai

Route (s) of administration

vartoti ant pažeistos vietos

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

B02BC30, Combinations

Marketing authorisation holder

Mallinckrodt Pharmaceuticals Ireland Limited, Airija

Date of authorisation

2015-03-19

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Sealant powder	1 g
Žmogaus fibrinogenas	79 mg
Žmogaus trombinas	726 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
61689	76030	1076030	flakonas	0,5 g N1		Receptinis	EU/1/14/985/001	Netiekiama	-	-	No	-	-
61690	76031	1076031	flakonas	1 g N1		Receptinis	EU/1/14/985/002	Netiekiama	-	-	No	-	-
61691	76032	1076032	flakonas	2 g N1		Receptinis	EU/1/14/985/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-03-29	Išregistruotas
2015-03-19	Registruotas