Last Updated on eMC 07-09-2017 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 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 4.9 - Overdose
  • Change to section 7 - Marketing authorisation holder

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 4.3: contraindication for concomitant use with the medicinal products containing ombitasvir / paritaprevir / ritonavir or dasabuvir

-       Section 4.4: information added on ALT elevations with concomitant use of above products

-       Section 4.5: information added on enzyme induction and pharmacodynamics interactions, again related to use of above products.

-       Section 4.9: harmonisation of wording regarding symptoms of overdose.

-       Section 7: Update to the MAH address.

Reasons for adding or updating:

  • Change to section 10 - Date of revision of the text
  • Removal of black triangle

Date of revision of text on the SPC:14-03-2017

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 symbol, Dianette has been removed from the list of medicinal products subject to additional monitoring.

Reasons for adding or updating:

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:26-04-2016

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



The key changes are:

  • Update to section 4.5 Interactions, to removed duplicate information.

Reasons for adding or updating:

  • 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:05-08-2015

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



The key changes are:

·        To include ‘increased blood pressure’ into section 4.8, within the column adverse events reported post-marketing.

Reasons for adding or updating:

  • Change to section 10 - Date of revision of the text
  • Change to section 4.2 - Posology and method of administration

Date of revision of text on the SPC:08-05-2015

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



The key changes are:
To include information into section 4.2 of the SPC on special populations in line with standard templates. (The additional information is not new.)

Reasons for adding or updating:

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:01-05-2014

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



The key changes are:

 

Section 4.5 deletion of information on drug interaction between COCs and non-enzyme inducing antibiotics. 

Reasons for adding or updating:

  • Change to section 3 - Pharmaceutical form
  • 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:25-03-2014

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



The key changes are:

 

·        Update to Section 4.8 with aligned consequential changes to the PIL section 4.1:

 

Post-marketing reports of severe depression (including very rare reports of suicidal ideation or behaviour) in patients using Dianette have been received.  However, a causal relationship between clinical depression and Dianette has not been established....................

 

·        In addition, an editorial amendment to the description of the tablet shape and colouring was also approved recently for SmPC section 3 as follows (additional text highlighted):

 

Sugar-coated tablets.    

 

Beige, round tablet, with convex faces.

 

 

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects
  • Change to section 1 - Name of the medicinal product
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text
  • Addition of black triangle
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.3 - Contraindications

Date of revision of text on the SPC:30-07-2013

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



The key changes are:
·        To introduce the Black Triangle symbol and associated text into the SmPC/PIL, indicating that this product is subject to Additional Monitoring (PASS).
·        Updates and amendments to SmPC sections 1, 4.1, 4.2, 4.3, 4.4 and 4.8 (with associated consequential changes to the PIL),  in line with the text agreed by the EMA’s  Pharmacovigilance Risk Assessment Committee (PRAC) and published in the EC Decision

Reasons for adding or updating:

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

Date of revision of text on the SPC:06-03-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The key changes to the SmPC are:

  •  Section 7, removal of the trading style.

Reasons for adding or updating:

  • Change to section 10 date of revision of the text
  • Extra statutory information

Date of revision of text on the SPC:14-02-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The key changes to the SmPC are:

·        Overall update of the SmPC in line with the Company Core Datasheet and Core Safety Profile (as agreed on a European level).

·        Section 10, Date of revision of the text.

 

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration

Date of revision of text on the SPC:05-11-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The key changes are:

  • The length of use statement has been moved from Section 4.1 ‘Therapeutic indications’ of the Dianette SmPC to section 4.2 ‘Posology and method of administration'.

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 10 date of revision of the text

Date of revision of text on the SPC:27-05-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 2 ( Qualatative and quantative composition) - has been amended to reflect current standard terminology in line with the European Guideline on the Summary of Product Characteristics

Section 4.4 ( Special warnings) As the Dianette tablets contain lactose and sucrose the warning statements for lactose and sucrose from the Notice to Applicants; ENTR/F2/BL D (2003) were added to Section 4.4 of the SmPC.

Section 10 ( Revision date) - this is now 27 May 2010

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • 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:01-05-2008

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

The MA Holder has changed from Schering Health Care Limited to Bayer plc. 

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:01-06-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

The following sections have been updated with revised depression warnings:
Section 4.4 (Special warnings and special precautions for use)
Section 4.8 (Undesirable effects)
Section 10 (Date of revision of the text) - this has been updated to 26th June 2007. 

Reasons for adding or updating:

  • Change from the BAN of the active substance to the rINN

Reasons for adding or updating:

  • Change to section 9 - Date of Renewal of Authorisation

Reasons for adding or updating:

  • Change to section 9 - Date of Renewal of Authorisation

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 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 (date of (partial) revision of the text

Reasons for adding or updating:

  • Transferred from eMC version 1

Reasons for adding or updating:

  • No reasons supplied

Reasons for adding or updating:

  • No reasons supplied

Reasons for adding or updating:

  • No reasons supplied