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Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 27/06/18

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Summary of Product Characteristics last updated on medicines.ie: 7/7/2016
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Orion Pharma (Ireland) Ltd

Orion Pharma (Ireland) Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name Bufomix Easyhaler 160 micrograms/4.5 micrograms Active Ingredients Budesonide, Formoterol fumarate dihydrate
Medicine Name Bufomix Easyhaler 320 micrograms/9 micrograms Active Ingredients Budesonide, Formoterol fumarate dihydrate
Medicine Name Bufomix Easyhaler 80 micrograms/4.5 micrograms Active Ingredients Budesonide, Formoterol fumarate dihydrate
Medicine Name Comtess Active Ingredients Entacapone
Medicine Name Dexdor 100 micrograms/ml concentrate for solution for infusion Active Ingredients Dexmedetomidine hydrochloride
Medicine Name Divigel 0.1% Gel Active Ingredients Estradiol Hemihydrate
Medicine Name Eldepryl 5 mg Tablets Active Ingredients Selegiline Hydrochloride
Medicine Name Fareston Active Ingredients Toremifene Citrate
Medicine Name Indivina Active Ingredients Estradiol valerate, Medroxyprogesterone Acetate
Medicine Name Indivina 1 mg/2.5 mg tablets Active Ingredients Estradiol valerate, Medroxyprogesterone Acetate
Medicine Name Indivina 1 mg/5 mg tablets Active Ingredients Estradiol valerate, Medroxyprogesterone Acetate
Medicine Name Indivina 2 mg/5 mg tablets Active Ingredients Estradiol valerate, Medroxyprogesterone Acetate
Medicine Name Methotrexate 10mg tablets Active Ingredients Methotrexate
Medicine Name Methotrexate 2.5mg tablet Active Ingredients Methotrexate
Medicine Name Methotrexate Orion 10 mg tablets Active Ingredients Methotrexate disodium
Medicine Name Methotrexate Orion 2.5 mg tablets Active Ingredients Methotrexate disodium
Medicine Name Stalevo 100 mg/25 mg/200 mg film-coated tablets Active Ingredients Carbidopa, Entacapone, Levodopa
Medicine Name Stalevo 125 mg/31.25 mg/200 mg film-coated tablets Active Ingredients Carbidopa, Entacapone, Levodopa
Medicine Name Stalevo 150 mg/37.5 mg/200 mg film-coated tablets Active Ingredients Carbidopa, Entacapone, Levodopa
Medicine Name Stalevo 175 mg/43.75 mg/200 mg film-coated tablets Active Ingredients Carbidopa, Entacapone, Levodopa
Medicine Name Stalevo 200 mg/50 mg/200 mg film-coated tablets Active Ingredients Carbidopa, Entacapone, Levodopa
Medicine Name Stalevo 50 mg/12.5 mg/200 mg film-coated tablets Active Ingredients Carbidopa, Entacapone, Levodopa
Medicine Name Stalevo 75 mg/18.75 mg/200 mg film-coated tablets Active Ingredients Carbidopa, Entacapone, Levodopa
Medicine Name Toilax micro enema suspension Active Ingredients Bisacodyl
Medicine Name Veramil 120 mg Film-coated Tablets Active Ingredients verapamil hydrochloride
1 - 0 of 26 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 27 June 2018 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 22 July 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 22 July 2016 PIL

Reasons for updating

  • Change of manufacturer

Updated on 7 July 2016 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The safety information in sections 4.4 and 4.8 of the SPC in relation to the risks of ovarian cancer has been updated.

Updated on 7 July 2016 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 6 July 2016 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 3 September 2015 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

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 Special warnings and precautions for use has been updated to include: Hereditary angioedema in the sub- section 'Conditions which need supervision' Venous thromboembolism sub-section has been updated to include patients with a history of VTE Other conditions sub-section has been updated to include information on chloasma. Section 4.8 the table has been updated and information on myocardial infarction and gall bladder disease has been added to 'Other adverse reactions have been reported in association with estrogen/progestagen treatment'. US WHI studies - additional risk of breast cancer after 5 years’ use table is updated

Updated on 1 September 2015 PIL

Reasons for updating

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

Updated on 28 February 2014 SmPC

Reasons for updating

  • Change to section 6.4 - Special precautions for storage

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The storage conditions have been amended to store below 25oC (previously storage was below 30oC).

Updated on 25 February 2014 PIL

Reasons for updating

  • Change to storage instructions

Updated on 3 May 2012 SmPC

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

New individual SmPC for product (was previously in a combined SmPC).

The SmPC is updated in line with core safety text for HRT products

Updated on 2 May 2012 PIL

Reasons for updating

  • Change to date of revision

Updated on 3 February 2011 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 18 March 2010 PIL

Reasons for updating

  • Change to date of revision
  • Improved electronic presentation

Updated on 15 August 2006 PIL

Reasons for updating

  • Change to date of revision

Updated on 2 August 2005 PIL

Reasons for updating

  • New PIL for medicines.ie