Colecalciferol Fresenius

Medicinal product

(Invented) name

Colecalciferol Fresenius

Active substance (s)

Kolekalciferolis

Strength

14400 TV/ml

Pharmaceutical form

geriamieji lašai (tirpalas)

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A11CC05, Colecalciferol

Marketing authorisation holder

Fresenius Kabi Polska Sp.z.o.o., Lenkija

Date of authorisation

2021-03-18

Date of renewal

2021-09-22

Documents

4704 pakuotes lapelis_2021-09-22.doc

4704 Colecalciferol Fresenius_perr2021-09-22.doc

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

AT/H/0578/001/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

1 ml (36 lašuose) yra:	1 ml
Kolekalciferolis	14400 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
106147	92248	1092248	buteliukas	12,5 ml N1		Receptinis	LT/1/21/4704/001	Netiekiama	-	-	No	-	-
106148	92249	1092249	buteliukas	25 ml N1		Receptinis	LT/1/21/4704/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-09-22	Perregistruotas
2021-03-18	Registruotas