Enzepi

Medicinal product

(Invented) name

Enzepi

Active substance (s)

Lipazė/Amilazė/Proteazė

Strength

25000 V/>=4800 V/>=410 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	25000 V
Amilazė	>=4800 V
Proteazė	>=410 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
66255	80778	1080778	buteliukas	N20		Receptinis	EU/1/16/1113/009	Netiekiama	-	-	No	-	-
66256	80779	1080779	buteliukas	N50		Receptinis	EU/1/16/1113/010	Netiekiama	-	-	No	-	-
66257	80780	1080780	buteliukas	N100		Receptinis	EU/1/16/1113/011	Netiekiama	-	-	No	-	-
66258	80781	1080781	buteliukas	N200		Receptinis	EU/1/16/1113/012	Netiekiama	-	-	No	-	-

Stadijos

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