Atozet 10mg/10mg, 10mg/20mg, 10mg/40mg and 10mg/80mg film-coated tablets

  • Name:

    Atozet 10mg/10mg, 10mg/20mg, 10mg/40mg and 10mg/80mg film-coated tablets

  • Company:
    info
  • Active Ingredients:

    Atorvastatin calcium trihydrate, ezetimibe

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 25/09/19

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Summary of Product Characteristics last updated on medicines.ie: 18/10/2019

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MSD Ireland (Human Health) Limited

MSD Ireland (Human Health) Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Adempas Film Coated Tablets Active Ingredients Riociguat
Medicine Name Arcoxia 30 60 90 120 film-coated tablets Active Ingredients Etoricoxib
Medicine Name Atozet 10mg/10mg, 10mg/20mg, 10mg/40mg and 10mg/80mg film-coated tablets Active Ingredients Atorvastatin calcium trihydrate, ezetimibe
Medicine Name Bridion Active Ingredients Sugammadex sodium
Medicine Name Cancidas 50mg Powder for concentrate for solution for infusion Active Ingredients caspofungin acetate
Medicine Name Cancidas 70mg Powder for concentrate for solution for infusion Active Ingredients caspofungin acetate
Medicine Name Cerazette 75 microgram film-coated tablet Active Ingredients Desogestrel
Medicine Name Cozaar 12.5mg, 50mg & 100mg Film-coated Tablets Active Ingredients Losartan potassium
Medicine Name Cozaar 2.5mg/ml Powder and Solvent for Oral Suspension Active Ingredients Losartan potassium
Medicine Name Cozaar COMP 50 mg/12.5 mg, 100 mg/12.5 mg, 100 mg/25 mg film-coated tablets Active Ingredients Hydrochlorothiazide, Losartan potassium
Medicine Name Cubicin 350mg Powder for Solution for injection or infusion Active Ingredients Daptomycin
Medicine Name Cubicin 500mg powder for solution for injection or infusion Active Ingredients Daptomycin
Medicine Name Delstrigo 100 mg/300 mg/245 mg film-coated tablets Active Ingredients Lamivudine, Tenofovir disoproxil fumarate, Doravirine
Medicine Name Diprosalic Scalp Application Active Ingredients Betamethasone dipropionate, Salicylic Acid
Medicine Name Elocon Cream Active Ingredients Mometasone Furoate
Medicine Name Elocon Ointment Active Ingredients Mometasone Furoate
Medicine Name Elocon Scalp Lotion Active Ingredients Mometasone Furoate
Medicine Name EMEND 125 mg hard capsules Active Ingredients Aprepitant
Medicine Name EMEND 80 mg hard capsules Active Ingredients Aprepitant
Medicine Name EMEND 80mg, 125mg hard Capsules Active Ingredients Aprepitant
Medicine Name Esmeron Active Ingredients Rocuronium Bromide
Medicine Name EZETROL 10 mg Tablets Active Ingredients ezetimibe
Medicine Name FOSAMAX Once Weekly 70 mg Tablets Active Ingredients Alendronate Sodium Trihydrate
Medicine Name FOSAVANCE Active Ingredients Alendronate Sodium Trihydrate, Colecalciferol (Vitamin D3)
Medicine Name GARDASIL Active Ingredients human papillomavirus vaccine
1 - 0 of 84 items.Total: Infinity pages

When a pharmaceutical company changes any document, 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 18 October 2019 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Correction to section 4.8

Updated on 25 September 2019 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

PIL change to section 2 - interactions with other medicines, food or drink, Change to section 3 - how to take/use, Change to section 4 - possible side effects, Change to section 6 - date of revision

 

Updated on 20 September 2019 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Updates to section 4.8 Undesirable effects and section 10. Date of revision following approval of WS/613 - PRAC recommendation regards to Lupus-like Syndrome

 

Updated on 13 August 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to further information section
  • Change to date of revision

Updated on 31 July 2019 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Updates to section 4.8 Undesirable effects and section 10. Date of revision following approval of WS609 PRAC Muscle Rupture

 

Updated on 12 April 2019 SmPC

Reasons for updating

  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Changes to 9. Date of first authorisation/renewal of authorisation

 

Updated on 22 March 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 14 March 2019 SmPC

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

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Updates to SPC following approval of WS566 - Interactions with antivirals

Updated on 20 July 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 10 July 2018 SmPC

Reasons for updating

  • 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

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Changes to 7. Marketing Authorisation Holder  and Section 10 – Date of revision of the text following approval of MA Transfer

Updated on 14 November 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 14 November 2017 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 8 November 2017 SmPC

Reasons for 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
  • Correction of spelling/typing errors
  • Improved presentation of SPC

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Updates to sections 4.5 and 10 and Correction of spelling/typing errors  and Improved presentation of SPC as a result of approval of Type II variation (DE/H/xxxx/WS/385) DDI xref Safety Label Update

Updated on 8 November 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 11 May 2017 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 2 May 2017 SmPC

Reasons for 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 4.5 - 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

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Updates to sections 4.2, 4.4, 4.5, 5.2 and 10 as a result of approval of Type II variation (DE/H/xxxx/WS/335) DDI of BCRP inhibitors with HMG-CoA reductase inhibitors (statins)

Updated on 6 May 2016 SmPC

Reasons for 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

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Sections   4.4 & 4.5 
SPC Change Details: to include a warning on concomitant use with fusidic acid

Updated on 5 May 2016 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to drug interactions

Updated on 12 February 2016 SmPC

Reasons for 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 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Tell us all the sections of your SPC that have changed: 4.1, 4.2, 4.4, 4.8, 5.1

SPC Change Details: In section 4.1, a new indication for “Prevention of Cardiovascular Events” has been added (with corresponding updates to other sections)

Updated on 11 February 2016 SmPC

Reasons for 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 - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

SPC Change Details  4.1, 4.2, 4.4, 4.8, 5.1
In section 4.1, a new indication for “Prevention of Cardiovascular Events” has been added (with corresponding updates to other sections)

Updated on 11 February 2016 PIL

Reasons for updating

  • Changes to therapeutic indications

Updated on 15 July 2015 SmPC

Reasons for 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

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to Section 4.4 - Special warnings and precautions for use, Change to Section 4.8 - Undesirable effects and Change to Section 10 - Date of revision of the text
Brief outline of changes to SPC sections listed above
Update to PI according to PRAC recommendation on IMNM

Updated on 14 July 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 11 May 2015 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 8 May 2015 PIL

Reasons for updating

  • New PIL for new product