Last Updated on eMC 15-11-2017 View medicine  | Merck Sharp & Dohme 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 5.1 - Pharmacodynamic properties
  • 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:12-10-2017

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



·         Section 5.1 Pharmacodynamic properties is updated to reflect:

-            Results from study 12935 (PATENT-2): Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral riociguat (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic pulmonary arterial hypertension

-            Results from study 11349 (CHEST-2): Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral riociguat (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with chronic thromboembolic pulmonary hypertension

-            Results from study 13605 (RISE-IIP): A randomized, double-blind, placebo-controlled phase II study to investigate the efficacy and safety of riociguat (0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg and 2.5 mg tid) in patients with symptomatic pulmonary hypertension associated with idiopathic interstitial pneumonias

·         Section 4.8 Undesirable effects: Reporting of suspected adverse reactions

-            Search for MHRA Yellow Card: reference to the Google Play and Apple App Store is added

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:02-05-2017

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



-        Section 7 - MARKETING AUTHORISATION HOLDER - updated to reflect the change in the Marketing Authorisation Holder name and address details: Bayer Pharma AG 13342 Berlin Germany to Bayer AG 51368 Leverkusen Germany

Reasons for adding or updating:

  • 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 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:26-01-2017

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



·        Section 4.4 – Special Warnings and Precautions for use: Updated to reinforce the existing messages in sections 4.3 and 4.6 with regards to pregnancy.

·        Section 4.5 - Interactions with other medicinal products and other forms of interaction: Iinformation added about interactions of riociguat when administered concomitantly with combined oral contraceptives containing levonorgestrel and ethinyl estradiol to healthy female subjects. The list of CYP isoforms involved in the metabolism of riociguat based on in vitro data has been corrected.

·        Section 5.2 - Pharmacokinetic properties: The list of CYP isoforms involved in the metabolism of riociguat based on in vitro data has been corrected.

·        The Product Information was brought into line with the latest QRD template version 10.0. This affected the SmPC by formatting and slight wording modifications in sections 2, 3, 4.4, 4.6, 6.1 and 8.

Reasons for adding or updating:

  • Change to section 4.3 - Contraindications
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:04-07-2016

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



·       Section 4.3 – Contraindications: new contraindication “Patients with pulmonary hypertension (PH) associated with idiopathic interstitial pneumonias (IIP)”.

·       Section 5.1 – Pharmacodynamic properties: Clinical efficacy and safety details added from the RISE-IIP study which resulted in the new contraindication.

Reasons for adding or updating:

  • Change from individual to joint SPC

Date of revision of text on the SPC:01-07-2015

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

SmPC title changed to combine strengths.

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Date of revision of text on the SPC:01-07-2015

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



  • To include information on crushed tablets in sections 4.2 and 5.2
  • Include the phrase "recreational drugs called 'poppers' in sections 4.3 and 4.5
  • Include commas after each ADR in table 1 of section 4.8
  • Deletion of 'mean LS' in table 2 of section 5.1
  • IDT is defined under table 3 of section 5.1 (individual dose titration)

Reasons for adding or updating:

  • Change to section 6.5 - Nature and contents of container
  • 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:14-10-2014

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



The key changes are:

·        Section 6.5: ……Pack sizes: 42, 84, 90 or 294 film-coated tablets…..

·        Section 8: addition of the new MA numbers for the 294 pack for each strength

·        Section 10: date of revision added.

 

 

Reasons for adding or updating:

  • New SPC for new product

Date of revision of text on the SPC:01-01-0001

Legal Category:POM

Black Triangle (CHM): YES