Kaletra

Medicinal product

(Invented) name

Kaletra

Active substance (s)

Lopinaviras/Ritonaviras

Strength

80 mg/20 mg/ml

Pharmaceutical form

geriamasis tirpalas

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J05AR10, Lopinavir and ritonavir

Marketing authorisation holder

AbbVie Deutschland GmbH & Co. KG , Vokietija

Date of authorisation

2001-03-20

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Oral solution	1 ml
Lopinaviras	80 mg
Ritonaviras	20 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
5004	10318	1010318	buteliukas	60 ml ir dozavimo švirkštas (5 ml) N5		Receptinis	EU/1/01/172/003	Netiekiama	-	-	No	-	-
98187	84285	1084285	buteliukas	60 ml ir dozavimo švirkštas (2 ml) N2		Receptinis	EU/1/01/172/009	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2001-03-20	Registruotas