ProZinc

Authorised

This medicine is authorised for use in the European Union

insulin human

Overview

Up-to-date information on this veterinary medicinal product is available on the Veterinary Medicines Information website

ProZinc : EPAR - Medicine overview

Reference Number: EMA/300817/2013

Product information

ProZinc : EPAR - Product Information

ProZinc : EPAR - All Authorised presentations

Product details

• Name of medicine:
  ProZinc
• Active substance:
  Insulin human
• International non-proprietary name (INN) or common name:
  insulin human

Pharmacotherapeutic group

Insulins and analogues for injection, intermediate-acting

Authorisation details

• EMA product number:
  EMEA/V/C/002634

Assessment history

Changes since initial authorisation of medicine

ProZinc : EPAR - Procedural steps taken and scientific information after authorisation

ProZinc-V-C-2634-II-0015 : EPAR - Assessment report - Variation

Adopted Reference Number: EMA/200382/2019

CVMP post-authorisation summary of positive opinion for ProZinc (II-0015)

Adopted Reference Number: EMA/CVMP/147691/2019

Initial marketing authorisation documents

ProZinc : EPAR - Public assessment report

CVMP summary of positive opinion for ProZinc

Adopted Reference Number: EMA/CVMP/250455/2013