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Ovreena 30 micrograms/150 micrograms coated tablets

  • Name:

    Ovreena 30 micrograms/150 micrograms coated tablets

  • Company:
    info
  • Active Ingredients:

    Ethinylestradiol, Levonorgestrel

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 22/05/20

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Summary of Product Characteristics last updated on medicines.ie: 22/5/2020

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Consilient Health Ltd

Consilient Health Ltd

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Medicine Name altavitaD3 25,000 IU oral solution Active Ingredients Colecalciferol (Vitamin D3)
Medicine Name altavitaD3 25,000 IU soft capsules Active Ingredients Colecalciferol (Vitamin D3)
Medicine Name altavitaD3 7,000 IU soft capsules Active Ingredients Colecalciferol (Vitamin D3)
Medicine Name Azalia 75 microgram film-coated tablets Active Ingredients Desogestrel
Medicine Name Cadelius 600 mg / 1,000 IU orodispersible tablets Active Ingredients Calcium Carbonate, Colecalciferol (Vitamin D3)
Medicine Name Cilique 250/ 35 microgram tablets Active Ingredients Ethinylestradiol, Norgestimate
Medicine Name Elvina 0.03mg/3mg Film-coated Tablets Active Ingredients Drospirenone, Ethinylestradiol
Medicine Name Elvinette 0.02mg/3mg film-coated tablets Active Ingredients Drospirenone, Ethinylestradiol
Medicine Name Mysimba 8 mg/90 mg prolonged-release tablets Active Ingredients Bupropion Hydrochloride, Naltrexone Hydrochloride
Medicine Name Ovreena 30 micrograms/150 micrograms coated tablets Active Ingredients Ethinylestradiol, Levonorgestrel
Medicine Name Violite 100/20 micrograms film-coated tablets Active Ingredients Ethinylestradiol, Levonorgestrel
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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 22 May 2020 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 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

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

Updated on 22 May 2020 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 20 May 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 18 May 2019 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Updated following PRAC recommendation 

Updated on 16 November 2017 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 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
  • 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

SmPC update

Updated on 16 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 15 November 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 15 November 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 15 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 4.3 - 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 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic 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

Almost rewrite of the SmPC to bring in line with Article 31 referral.$0Also updated to bring in line with QRD.$0

Updated on 8 February 2016 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to instructions about missed dose
  • Change to instructions about overdose
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery

Updated on 22 September 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 17 September 2015 PIL

Reasons for updating

  • New PIL for new product