Zemplar

Medicinal product

(Invented) name

Zemplar

Active substance (s)

Parikalcitolis

Strength

1 µg

Pharmaceutical form

minkštosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

H05BX02, Paricalcitol

Marketing authorisation holder

SIA AbbVie, Latvija

Date of authorisation

2008-03-06

Date of renewal

2012-05-09

Documents

1042_1_6 Zemplar kaps RPP 200127.docx

1042_1_6 Pakuotės lapelis 200127.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

ES/H/0113/002/MR

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

Kapsulėje yra	1 vnt.
Parikalcitolis	1 µg

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
22943	25676	1025676	lizdinė plokštelė	N7		Receptinis	LT/1/08/1042/001	Netiekiama	-	-	No	-	-
23385	26088	1026088	lizdinė plokštelė	N28		Receptinis	LT/1/08/1042/002	Netiekiama	-	-	No	-	-	Download
22942	25675	1025675	buteliukas	N30		Receptinis	LT/1/08/1042/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-12-29	Išregistruotas
2012-05-09	Perregistruotas
2008-03-06	Registruotas