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Hospira UK Ltd
Queensway, Royal Leamington Spa, Warwickshire, CV31 3RW
Telephone: +44 (0)1926 820 820
Fax: +44 (0) 1926 834446
WWW: http://www.hospira.com
Medical Information Direct Line: +44 (0) 1926 834400
Medical Information e-mail: medinfouk@hospira.com
Customer Care direct line: +44 (0)1926 821 022

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: 01/06/2011
SPC Epirubicin Hydrochloride 2 mg/ml Injection

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 01/06/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   09-Aug-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


9.         DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 DATE AMENDED

09/08/2010

10.       DATE OF REVISION OF THE TEXT

 

 DATE AMENDED

09/08/2010
Updated on 23/08/2010 and displayed until 01/06/2011
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 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Apr-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


4.3

2 bullet points added under “Epirubicin is contraindicated in:”

Heading added “For intraveneous use, epirubicin is contraindicated in:” with several changes made to the list

Heading added “For intravesical use epirubicin is contraindicated in:” with 4 items added to list

 

4.4

Paragraphs added starting, “Patients should recover from acute toxicities….” And following this “While treatment with high doses of epirubicin”

Additional paragraphs re Cardiac function, Early (ie Acute) Events, Late (ie Delayed) Events (3 paragraphs added with changes to existing 2 paragraphs), Haematologic Toxicity, Secondary Leukemia, Gastrointestinal, Liver Function, Renal Function, Effects at Site of Injection, Extravasation, Other, Tumour-Lysis Syndrome, Immunosuppressant Effects/Increased Susceptibility to Infections, Reproductive Systems, Intravesical route and Intra-arterial route.

Paragraph starting “Epirubicin may impart a red colour…” deleted

 

4.5

Amendment of 2nd paragraph and addition of 3 further paragraphs following this.

Addition of sentence at end of paragraph starting “Cimetidine..” with 6 additional paragraphs following this.

α2b amended to alfa-2b

 

4.6

Addition of section “Impairment of Fertility” (3 paragraphs)

Deletion of existing paragraph

New title “Pregnancy” with additions to end of 1st paragraph and start of 2nd paragraph.

Addition of title “Lactation” with 1 new paragraph.

 

4.7

One new sentence added

 

4.8

Side effects put into tabular format.

Side effects added

Paragraph re “Intravesical administration” added

 

4.9

2 sentences added with additional changes to existing wording.

 

10

April 2010 date added
Updated on 30/01/2009 and displayed until 23/08/2010
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   02-Jan-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


7.         MARKETING AUTHORISATION HOLDER

 Change to:

Hospira UK LimitedQueensway

Royal Leamington Spa

Warwickshire

CV31 3RW

 

9.         DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 

22/07/2005


10.       DATE OF REVISION OF THE TEXT

 

02/01/2008

 
Updated on 09/08/2006 and displayed until 30/01/2009
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  epirubicin hydrochloride