Last Updated on eMC 26-09-2017 View medicine  | Bayer plc 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 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:31-08-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



  • Section 7 - the MAH address has been updated
  • Date of revision of text has changed.

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

Date of revision of text on the SPC:12-12-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The key changes are:

 

SmPC Section 4.4, inclusion of Thrombophilia warning.

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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:23-03-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The key changes to the SmPC are (with consequential changes to the PIL) are:

 

Ø  section 2 (Qualitative and quantitative composition)

Ø  sections 4.4 (Special warnings and precautions for use) àto add a warning on use of Testosterone in in case of severe cardiac, hepatic, or renal insufficiency or ischaemic heart disease” due to increased risk of sodium and water retention with androgen therapy, with the recommendation to “stop therapy immediately in case of severe complications characterized by oedema with or without congestive heart failure;

Ø  section 4.5 (Interaction with other medicinal products and other forms of interaction)à characterization of the oral anti-coagulants for which testosterone (and its derivatives) increase activities of, ascoumarin derived oral anti-coagulants”.

Ø  section 4.8 (Undesirable effects) à addition of the 2 new ADRs: “Pulmonary oil microembolism” with frequency “unknown” under a new SOC “Injury, poisoning and procedural complicationsandincreased hair growth” under the sub-tabular “Description of selected adverse reactions”.  In addition, editorial changes (addition of subheadings) in line with the QRD template and SmPC guideline (including addition of subheadings for special populations and minor formatting edits).

Ø  section 6.6 (Special precautions for disposal and other handling) à addition of a description for the handling of the vial (including a diagrammatic representation).

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:18-01-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The key changes are:

·        Sections 4.4 (Special warnings and precautions for use) àto add a paragraph on the laboratory monitoring of testosterone level to ensure maintenance of eugonadal testosterone levels” and “a warning on use of Testosterone in men with hypertension”;

·        Section 4.8 (Undesirable effects) àto change the frequency of the ADRs: Haematocrit increased, Red blood cell count increased and Haemoglobin increased, from “uncommon” to “common”.

·        Editorial changes were made in line with the current QRD template and SmPC guideline (including addition of subheadings for special populations and minor formatting edits).

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
  • Change to section 4.3 - Contraindications

Date of revision of text on the SPC:01-12-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The key changes are:

·        update with required ADR statements according to the new legislation

·        minor adaptations to standard QRD templates

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:14-11-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The key changes are:

·        To introduce a new vial presentation. 

Reasons for adding or updating:

  • 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

Date of revision of text on the SPC:20-04-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The key changes are:

 

·        Section 4.2: Additional detail that the injections must be administered very slowly over two minutes was added.

·        Section 4.4: Medical examination - reference to local guidelines added

Application – again the injection to be administered slowly over two minutes was added. Additional advice to observe the patient during and immediately after each injection for early recognition of possible signs/symptoms of pulmonary oily microembolism.

·        Section 4.8: Additional details on pulmonary oily microembolism.

Statement that androgens may accelerate the progression of sub-clinical prostatic cancer and benign prostatic hyperplasia.

 

Reasons for adding or updating:

  • Removal of Black Triangle

Date of revision of text on the SPC:23-09-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

The key changes are:

  • Removal of the black triangle. 

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:23-09-2011

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



The key changes are:

 

  • To remove the trading style statement in section 7 of the SmPC.

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:01-08-2011

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Section 4.4 (Special warnings) Additional text concerning anaphylactic shock
Section 4.8 (Side effects) anaphylactic shock has been added
Section 10 - Revision date is now August 2011

Reasons for adding or updating:

  • Change to section 1 -Name of the Medicinal product
  • 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 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:19-01-2011

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



The key changes to the SmPC are:

1. Name of the medicinal product: Editorial change to correct spacing

4.2 Posology and method of administration: Section 4.2 now divided clearly under the headings "Posology" and "Method of administration".Inclusion of information on special populations (geriatric patients, patients with hepatic impairment, patients with renal impairment) in order to reflect current requirements. Order of subsections rearragned in line with QRD template.

Section 4.2 now divided clearly under the headings "Posology" and "Method of administration".Inclusion of information on special populations (geriatric patients, patients with hepatic impairment, patients with renal impairment) in order to reflect current requirements. Order of subsections rearragned in line with QRD template.

4.3 Contraindications. Inclusion of contraindication in women in line with SmPC guideline

Inclusion of contraindication in women in line with SmPC guideline

4.4 Special warnings and precautions for use: Elimination of frequencies in the statement regarding benign and malignant liver tumours and replacement of the term "testosterone" compounds by "androgen" compounds. Statement regarding liver tumor diagnosis added. Inclusion of an explanatory statement regarding oedema predisposition and a cross-reference to section 4.8

Elimination of frequencies in the statement regarding benign and malignant liver tumours and replacement of the term "testosterone" compounds by "androgen" compounds. Statement regarding liver tumor diagnosis added. Inclusion of an explanatory statement regarding oedema predisposition and a cross-reference to section 4.8

4.6 Pregnancy and lactation: Inclusion of information regarding fertility and cross-references to section 4.8 and 5.3

: Inclusion of information regarding fertility and cross-references to section 4.8 and 5.3

4.8 Undesirable effects: Editorial change to move position of frequency definitions

: Editorial change to move position of frequency definitions

5.2 Pharmacokinetic properties: Typographical corrections

: Typographical corrections

6.6 Instructions for use/handling: Inclusion of information regarding the handling of the OPC ampoule and a graphic demonstration

Inclusion of information regarding the handling of the OPC ampoule and a graphic demonstration

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:25-11-2008

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



The key SmPC changes are as follows:

Section 4.4, "Application "

: this has been revised to reflect recent clinical study and post-marketing experience, which report rare, short-lasting reactions to Nebido injection, believed to be due to the "pulmonary oily microembolism" (POME) phenomenon, causing symptoms such as the urge to cough and respiratory distress. The previous version of the SmPC provided no explanation for these side effects, with the consequence that they were occasionally misinterpreted as allergic reactions. This new version of the SmPC describes these reactions more specifically and references POME as a potential cause.

Section 4.8

: Table 1 has been revised to reflect most recent clinical data and recoded in line with MedDRA. As a result, several AEs have been added and pre-existing AEs regraded according to the most recent data on frequency. A paragraph on POME has also been added to this section to reflect recent clinical and post-marketing data.

Reasons for adding or updating:

  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 7 - Marketing Authorisation Holder
  • 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): YES

Free-text change information supplied by the pharmaceutical company:

Sections 7, 8, 9 and 10 have been updated to reflect the change of ownership from Schering Health Care Limited (PL 00053/0350) to Bayer plc (PL 00010/0549). 

Reasons for adding or updating:

  • Change to section 6. 3 - Shelf Life

Date of revision of text on the SPC:01-11-2006

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 6.3 change in shelf - life from 3 to 5 years

Reasons for adding or updating:

  • New SPC for new product