Boncel

Medicinal product

(Invented) name

Boncel

Active substance (s)

Kolekalciferolis

Strength

25 000 TV

Pharmaceutical form

geriamasis 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

UAB Orivas, Lietuva

Date of authorisation

2018-02-26

Date of renewal

2023-06-08

Documents

4199 Boncel 25000TV RPP 2025 07 09.docx

4199 Pakuotės lapelis 2025 07 09.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

LV/H/0146/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Kolekalciferolis	25 000 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
98998	85102	1085102	ampulė	1 ml N1		Receptinis	LT/1/18/4199/001	Netiekiama	-	-	No	-	-
98999	85103	1085103	ampulė	1 ml N2		Receptinis	LT/1/18/4199/002	Netiekiama	-	-	No	-	-
99000	85104	1085104	ampulė	1 ml N3		Receptinis	LT/1/18/4199/003	Netiekiama	-	-	No	-	-
99001	85105	1085105	ampulė	1 ml N4		Receptinis	LT/1/18/4199/004	Tiekiama	-	-	No	-	-
118188	104296	1104296	ampulė	1 ml N12		Receptinis	LT/1/18/4199/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-06-08	Perregistruotas
2018-02-26	Registruotas