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Consilient Health Ltd

Block 2A Richview Office Park, Clonskeagh, Dublin 14, Ireland
Telephone: 353 1 2057760
Medical Information Direct Line: +44 (0) 203 751 1888
Medical Information e-mail: drugsafety@consilienthealth.com
Medical Information Facsimile: +44 (0) 203 751 1889
Summary of Product Characteristics last updated on medicines.ie: 2/13/2018
SPC Mysimba 8 mg/90 mg prolonged-release tablets

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 2/13/2018 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
Date of revision of text on the SPC:   26-Jan-2018
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

$0Section4.2: Updated posology for patients with renal impairment $0$0Section 4.3: Contraindication forsevere renal impairment removed$0$0Section 4.4: Updated specialwarnings and precautions for use in patients with renal impairment $0$0Section 4.8: Additional informationregarding possible side effects in patients with renal impairment $0$0Section 5.2: Updated informationfor Pharmacokinetic properties in patients with renal impairment$0
Updated on 11/20/2017 and displayed until 2/13/2018
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 6.5 - Nature and contents of container
Date of revision of text on the SPC:   01-Sep-2017
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

Section 4.4 - Additional wording for elevation of blood pressure$0$0$0$0Section 4.8 - Additional side effects listed in table$0$0$0$0$0Section 6.5 - 28 pack size added.$0
Updated on 6/29/2017 and displayed until 11/20/2017
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

None provided

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