Register of
Medicinal Products
Human medicines
Veterinary medicines
Medical nutritions
User
Listings
Data download
Veterinary medicines
Search for medicinal products
Search for packages
ATC tree
Print
MEZYM 10 000
General data
Product class:
Authorized package
Medicinal product class:
For human use
Package code:
1121937
Name of medicinal product:
MEZYM 10 000
Active substances:
Lipase+Amylase+Protease
Estonian
,
English
,
Latin
ATC code:
A09AA02
Dosage form:
gastro-resistant tablet
Route of administration:
oral use
Strengh:
10000ühik+7500ühik+375ühik
Amount in package:
100TK
Legal status for supply*:
Not subject to medicinal prescription
Class of active substance:
Additional information:
Indication:
Reduced exocrine pancreatic function (enzyme replacement therapy)Cystic fibrosis (mucoviscidosis).
Safety features:
No
Summary of product characteristics (SPC):
(last updated May 27, 2015)
Package information leaflet (PIL):
EST
(last updated May 27, 2015)
Translation of package information leaflet into Russian:
RUS
(last updated May 27, 2015)
Translation of package information leaflet into English:
ENG
(last updated May 27, 2015)
Labelling:
(last updated August 23, 2018)
Last imported to Estonia:
November 13, 2007
Marketing authorization
Marketing authorization holder:
Berlin-Chemie AG
Marketing authorization number:
416603
Marketing authorization issued on:
August 8, 2003
Marketing authorization expires on:
Unlimited
Marketing authorization procedure type:
National
Prices
Reference price:
Under reference price:
Reference price of daily dose:
Entry/Changing date: March 18, 2021
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
You can download Acrobat Reader from
here