Kreon 40000 V

Medicinal product

(Invented) name

Kreon 40000 V

Active substance (s)

Kasos milteliai (Lipazė/Amilazė/Proteazė)

Strength

400 mg (40000 V/25000 V/1600 V)

Pharmaceutical form

skrandyje neirios kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A09AA02, Multienzymes (lipase, protease etc.)

Marketing authorisation holder

Mylan IRE Healthcare Limited, Airija

Date of authorisation

2008-07-03

Date of renewal

2013-05-07

Documents

1201_2_7, 15 Pakuotės lapelis 210219.docx

1201_2_7, 9, 11, 14_15 Kreon kaps Rp RPP 210219.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Kapsulėje yra	1 vnt.
Kasos milteliai (Lipazė/Amilazė/Proteazė)	400 mg (40000 V/25000 V/1600 V)

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
18745	22289	1022289	buteliukas	N50		Receptinis	LT/1/97/1201/002	Netiekiama	-	-	No	-	-
18746	22290	1022290	buteliukas	N100		Receptinis	LT/1/97/1201/003	Netiekiama	-	-	No	-	-
49160	63027	1063027	buteliukas	N60		Receptinis	LT/1/97/1201/004	Netiekiama	-	-	No	-	-
49161	63028	1063028	buteliukas	N120		Receptinis	LT/1/97/1201/005	Netiekiama	-	-	No	-	-
49162	63029	1063029	buteliukas	N200		Receptinis	LT/1/97/1201/006	Netiekiama	-	-	No	-	-
49163	63030	1063030	buteliukas	N250		Receptinis	LT/1/97/1201/007	Netiekiama	-	-	No	-	-
60795	75085	1075085	lizdinė plokštelė	N20		Receptinis	LT/1/97/1201/015	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-12-29	Išregistruotas
2013-05-07	Perregistruotas
2008-07-03	Registruotas