Enzepi

Medicinal product

(Invented) name

Enzepi

Active substance (s)

Lipazė/Amilazė/Proteazė

Strength

5000 V/>=1600 V/>=130 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

Allergan Pharmaceuticals International Ltd., Airija

Date of authorisation

2016-06-29

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Gastro-resistant capsule, hard	1 vnt.
Lipazė	5000 V
Amilazė	>=1600 V
Proteazė	>=130 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
66247	80770	1080770	buteliukas	N20		Receptinis	EU/1/16/1113/001	Netiekiama	-	-	No	-	-
66248	80771	1080771	buteliukas	N50		Receptinis	EU/1/16/1113/002	Netiekiama	-	-	No	-	-
66249	80772	1080772	buteliukas	N100		Receptinis	EU/1/16/1113/003	Netiekiama	-	-	No	-	-
66250	80773	1080773	buteliukas	N200		Receptinis	EU/1/16/1113/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-07-21	Išregistruotas
2016-06-29	Registruotas