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Prosulf 10mg/ml Solution for Injection

Last Updated on eMC 22-Apr-2016 View document  | 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.

Updated on 22-Apr-2016 and displayed until Current

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-Feb-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Spelling of sulphate amended to sulfate

Updated on 04-Mar-2016 and displayed until 22-Apr-2016

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-Dec-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Addition of ADR reporting details 

Updated on 27-Sep-2010 and displayed until 04-Mar-2016

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-Sep-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'.

Updated on 27-Aug-2008 and displayed until 27-Sep-2010

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-May-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

Updated on 09-Jan-2004 and displayed until 27-Aug-2008

Reasons for adding or updating:

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

Company contact details

Wockhardt UK Ltd

Company image
Address

Ash Road North, Wrexham Industrial Estate, Wrexham, LL13 9UF

Fax

+44 (0)1978 660 130

Telephone

+44 (0)1978 661 261

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?

Active ingredients

protamine sulfate

Legal categories

POM - Prescription Only Medicine

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