Kreon 35000 V

Medicinal product

(Invented) name

Kreon 35000 V

Active substance (s)

Kasos milteliai (Lipazė/Amilazė/Proteazė)

Strength

420 mg (35000 V/25200 V/1400 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

Viatris Healthcare Limited, Airija

Date of authorisation

2018-12-28

Date of renewal

2023-07-26

Documents

4318_4319 Kreon PCS PL 2024 06 19, 35000V_PL 2023 10 10.docx

4319 Pakuotės lapelis 35000V 2023 10 10.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

DE/H/5183/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kapsulėje yra:	1 vnt.
Kasos milteliai (Lipazė/Amilazė/Proteazė)	420 mg (35000 V/25200 V/1400 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
100738	86848	1086848	buteliukas	N50		Receptinis	LT/1/18/4319/001	Netiekiama	-	-	No	-	-
100739	86849	1086849	buteliukas	N60		Receptinis	LT/1/18/4319/002	Netiekiama	-	-	No	-	-
100740	86850	1086850	buteliukas	N100		Receptinis	LT/1/18/4319/003	Netiekiama	-	-	No	-	-
100741	86851	1086851	buteliukas	N120		Receptinis	LT/1/18/4319/004	Netiekiama	-	-	No	-	-
100742	86852	1086852	buteliukas	N200		Receptinis	LT/1/18/4319/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-07-26	Perregistruotas
2018-12-28	Registruotas