Last Updated on eMC 12-07-2018 View medicine  | Chugai Pharma UK Limited 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 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects - how to report a side effect

Date of revision of text on the SPC:01-03-2018

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



  • In section 4.4 (Special warnings and precautions for use) the following paragraph has been added at the bottom: Aortitis has been reported after G-CSF administration in healthy donors and in cancer patients. The symptoms experienced included fever, abdominal pain, malaise, back pain and increased inflammatory markers (e.g. C-reactive protein and white blood cell count). In most cases aortitis was diagnosed by CT scan and generally resolved after withdrawal of G-CSF. See also section 4.8.
  • In section 4.8 (Undesirable effects), the table has been updated to include Aortitis under rare adverse reactions.
  • In section 10, the date of revision has been updated.

Reasons for adding or updating:

  • 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 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:31-10-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

- In sections, 2 4.2, 4.3, 4.6 and 5.1 wording updating to align with latest QRD template, headings inserted
- In section 4.4 information about Glomerulonephritis added
- In section 4.8 (undesirable effects) musculoskeletal pain and glomerulonephritis added
- In section 10 date of revision amended

Reasons for adding or updating:

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

Date of revision of text on the SPC:23-04-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.4 (special warnings and precautions for use) of the SPC has been changed to introduce the potential risk of Sickle Cell Disease crisis.

Reasons for adding or updating:

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:01-07-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



·        In section 6.3, the shelf-life has been changed from 2 years to 30 months.

·        In section 10, the date of revision is now July 2014.

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 4.8 - Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:01-12-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 4.4 (special warnings and precautions for use), description of Capillary leak syndrome is added.
In section 4.8 (undesirable effects), description of Capillary leak syndrome as a post-marketing life-threatening adverse drug reaction and its frequency "uncommon" have been added.
In section 4.8 reporting of suspected adverse reactions has been added.
In section 10 the date of revision is now December 2013.

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 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:01-05-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In Section 4.3, "see section 4.4" has been added in relation to hypersensitivity.$0In Section 4.4, the following statement has been added, "The tip cap composition of the pre-filled syringe contains latex rubber which may cause severe allergic reactions in predisposed subjects."$0In Section 6.5, reference to the tip cap and latex has been added.$0The date of revision has changed to May 2013.

Reasons for adding or updating:

  • Correction of spelling/typing errors

Date of revision of text on the SPC:01-07-2012

Legal Category:POM

Black Triangle (CHM): NO

Reasons for adding or updating:

  • 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 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
  • change to paediatric information

Date of revision of text on the SPC:01-07-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Sections 4.1, 4.2, 4.4 and 4.8 have been updated with information on paediatrics, in accordance with Article 45 of the paediatric regulation.

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 10 date of revision of the text

Date of revision of text on the SPC:29-04-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 4.4 Special warnings and precautions for use, pulmonary toxicity in healthy donors has been added.

In section 4.8 Undesirable effects, information on side effects observed in normal donors undergoing peripheral blood progenitor cell mobilisation has been added.

The SmPC text has been revised in April 2011.

Reasons for adding or updating:

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

Date of revision of text on the SPC:06-05-2009

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 4.4 (Special warnings and percautions for use) the following wording (in bold underlined) has been added.

Transient cytogenetic modifications have been observed in normal donors following G-CSF use. The significance of these changes is unknown.

Long-term safety follow up of donors is ongoing. Nevertheless, a risk of promotion of a malignant myeloid clone cannot be excluded. It is recommended that the apheresis centre perform a systematic record and tracking of the stem cell donors for at least 10 years to ensure monitoring of long-term safety.

The following wording (in italics) has been removed:

Data on long-term follow-up of donors are available on a small number of subjects. Up to six years, no emerging long-term sequelae have been reported. Nevertheless, a risk of promotion of a malignant myeloid clone is possible. Therefore, it is recommended that systematic recording and tracking of the stem-cell gifts be made by the apheresis centres.

Reasons for adding or updating:

  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6.1 - List of Excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 1 -Name of the Medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.6 - Pregnancy and Lactation

Date of revision of text on the SPC:19-08-2008

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

The SPC has been harominsed in line with the requirements for SPCs. Though no substantial changes have been made to the SPC, there have been updates to the presentation of the Name of the Product, the contraindications, posology, warnings, precautions and adverse events sections have been revised in line with the new requirements. Further information has been provided in the storage, pharmaceutical form and handling instructions.  

Reasons for adding or updating:

  • Improved Electronic Presentation

Reasons for adding or updating:

  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects

Reasons for adding or updating:

  • Correction of spelling/typing errors

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 5.3 - Preclinical Safety Data
  • Change to section 10 (date of (partial) revision of the text
  • Correction of spelling/typing errors

Reasons for adding or updating:

  • Correction of spelling/typing errors

Reasons for adding or updating:

  • Correction of spelling/typing errors