One-Alpha

Medicinal product

(Invented) name

One-Alpha

Active substance (s)

Alfakalcidolis

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)

A11CC03, Alfacalcidol

Marketing authorisation holder

LEO Pharma A/S, Danija

Date of authorisation

1995-04-05

Date of renewal

2009-05-13

Documents

1573_1_2 One_Alpha kaps PZ PL 181018.docx

1573_1_2 Pakuotės lapelis 181018.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Kapsulėje yra	1 vnt.
Alfakalcidolis	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
1215	2805	1002805	lizdinė plokštelė	N10		Receptinis	LT/1/95/1573/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-09-11	Išregistruotas
2009-05-13	Perregistruotas
1995-04-05	Registruotas