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Amgen Ltd
240 Cambridge Science Park, Milton Road, Cambridge, CB4 0WD
Telephone: +44 (0)1223 420 305
Fax: +44 (0)1223 426 314
Medical Information Direct Line: +44 (0)1223 436 441
Medical Information e-mail: gbinfoline@amgen.com
Customer Care direct line: +44 (0)808 0100 321
Medical Information Fax: +44 (0)1223 426 314

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: 06/05/2011
SPC Neupogen Singleject 48 MU (0.96 mg/ml)

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 06/05/2011 and displayed until Current
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 10 date of revision of the text
Date of revision of text on the SPC:   17-Mar-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


The following changes have been made to the Summary of Product Characteristics

·     Deletion of the statement in section 4.3 (Contraindications) “NEUPOGEN should not be used to increase the dose of cytotoxic chemotherapy beyond established dosage regimens“. 

·     Relocation of the statement “NEUPOGEN should not be administered to patients with severe congenital neutropenia (Kostman's syndrome) with abnormal cytogenetics“ that was in section 4.3 (Contraindications) to section 4.4 (Special Warnings and Precautions for Use) and to amend the statement.  

·     Deletion of the statement ‘If patients with SCN develop abnormal cytogenetics, the risks and benefits of continuing NEUPOGEN should be carefully weighed; NEUPOGEN should be discontinued if MDS or leukaemia occur’ from section 4.4, sub-section Transformation to leukaemia or myelodysplastic syndrome.
·         Update to section 10 (date of revision of the text) to 17 March 2011

Updated on 23/07/2010 and displayed until 06/05/2011
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6.1 - List of Excipients
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   05-Jul-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 2 - Updated to include information regarding the excipients sodium and sorbitol.

Section 4.4
Updated to include information regarding the excipients sodium and sorbitol.

Safety related terms have been amended in accordance to MedRA standard terms. 
Information to record the trade name of the administered product has been included.

Section 4.8 – Text has been revised in accordance to MedRA standard terms and a subsection ‘Post-marketing experience’ under the frequency category ‘unknown’ has been introduced.

 

Section 6.1 now lists the E number for sorbitol (E420).


Section 10 - The date of revision of text has been updated.

Updated on 21/07/2010 and displayed until 23/07/2010
Reasons for adding or updating:
  • New individual SPC (was previously included in combined SPC)
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided

Active Ingredients/Generics

 
  filgrastim