Last Updated on eMC 22-04-2016 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 1 - Name of the medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Date of revision of text on the SPC:26-02-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Spelling of sulphate amended to sulfate

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:22-12-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Addition of ADR reporting details 

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose

Date of revision of text on the SPC:17-09-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.1 - typographical amendments
Section 4.8 - section re-structured in line with MedDRA SOC subheadings.  'Anaphylactoid reactions' and 'severe, acute pulmonary vasoconstriction with cardiovascular collapse' added.  Additional information added regarding anticoagulant effect.
Section 4.9 - additional information regarding anticoagulant properties included.  Text added 'and/or a sensation of warmth may occur'.

Reasons for adding or updating:

  • Change to section 1 -Name of the Medicinal product
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:01-05-2008

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 1:
Prosulf            
Protamine Sulphate Injection BP
amended to :

Prosulf® 10mg/ml Solution for Injection
Protamine Sulphate 10mg/ml Solution for Injection

Section 7:
CP Pharamceuticals Ltd
amended to
Wockhardt UK Ltd

Section 8:
PL 04543/0234
amended to
PL 29831/0180

Section 9:
Date amended

Section 10:
Date amended

Reasons for adding or updating:

  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC