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Wockhardt UK Ltd

Ash Road North, Wrexham Industrial Estate, Wrexham, LL13 9UF
Telephone: +44 (0)1978 661 261
Fax: +44 (0)1978 660 130

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Summary of Product Characteristics last updated on the eMC: 27/03/2012
SPC Hypurin Bovine Neutral Cartridges

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 27/03/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   15-Mar-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



Section 4.4 – addition of information regarding hypoglycaemia

 

Section 4.8 – addition of information regarding neuropathic pain

 

Section 4.9 – supplemented with the potential for administering glucagon intravenously.

 

Updated on 08/07/2011 and displayed until 27/03/2012
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   23-Jun-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.4 updated - information regarding the use of Hypurin insulins with pioglitazone added.
Updated on 22/03/2011 and displayed until 08/07/2011
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 6.2 - Incompatibilities
Date of revision of text on the SPC:   27-Oct-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

SmPC changes to section 4.3, 4.4, 4.5, 4.6, 4.8, 4.9 and 6.2 clinical updates following PSUR.
Updated on 08/09/2008 and displayed until 22/03/2011
Reasons for adding or updating:
  • Change of Marketing Authorisation Holder
Date of revision of text on the SPC:   08-Apr-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 7 - 'CP Pharmaceuticals Ltd' amended to 'Wockhardt UK Ltd'

Section 8 - PL 04543/0366 amended to PL 29831/0127

Section 9 & 10 amended
Updated on 29/09/2003 and displayed until 08/09/2008
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
Updated on 04/09/2002 and displayed until 29/09/2003
Reasons for adding or updating:
  • Change to section 9 - Date of Renewal of Authorisation

Active Ingredients/Generics

 
   bovine insulin
   insulin
   beef insulin