Last Updated on eMC 25-01-2018 View medicine  | Wockhardt UK Ltd Contact details

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.

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration

Date of revision of text on the SPC:23-01-2018

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Update section 4.2 of the SmPC and sectons 2 and 3 of the PIL in line with PRAC recommendations.

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects - how to report a side effect

Date of revision of text on the SPC:15-12-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

ADR reporting instructions

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:02-01-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Update Section 4.4, 4.8 and 4.9 in line with PSUR.

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:15-03-2012

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.

 

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for Use

Date of revision of text on the SPC:23-06-2011

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.

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:27-10-2010

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.

Reasons for adding or updating:

  • Change of Marketing Authorisation Holder

Date of revision of text on the SPC:08-04-2008

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 04543/0374 amended to PL 29831/0122

Section 9 & 10 amended.

Reasons for adding or updating:

  • Change to section 6. 5 - Nature and Contents of Container

Reasons for adding or updating:

  • Change to section 9 - Date of Renewal of Authorisation