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Document information 23/09/2014 13:18
Current documents
SPC 2390
PIL 1993
Total: 4383
Submissions in the last 3 months
Updated: 991
New: 69

 

What's New

These are the latest new, updated and retired (removed) Summaries of Product Characteristics (known as SPCs or SmPCs) and Patient Information Leaflets (known as PILs, Package Leaflets or PLs) on medicines.ie. More help.

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Document Type:
PIL SPC
Status:  
New Update Retired
23 September 2014
New 3, Updated 7, Retired 0, [Total 10]
  • 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 5.2 - Pharmacokinetic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to dosage and administration
Active Ingredients: Fondaparinux sodium
Company: Aspen
  • New PIL for medicines.ie
Active Ingredients: Fondaparinux sodium
Company: Aspen
  • New PIL for medicines.ie
  • New PIL for medicines.ie
Active Ingredients: Fusidic Acid Hemihydrate
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
Active Ingredients: Sodium Fusidate
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
Active Ingredients: Meropenem Trihydrate
  • Change to side-effects
  • Change to date of revision
  • Change to section 4.1 - Therapeutic indications
  • 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
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Changes to therapeutic indications
22 September 2014
New 0, Updated 12, Retired 0, [Total 12]
  • Addition of information on reporting a side effect., Addition of black triangle
  • Addition of black triangle
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
Active Ingredients: Teriflunomide
  • Change to section 4.4 - Special warnings and precautions for use
Active Ingredients: Tenofovir disoproxil fumarate, Emtricitabine, Rilpivirine Hydrochloride
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
  • Change to date of revision, Addition of manufacturer
Active Ingredients: fingolimod hydrochloride
  • Change to, or new use for medicine
  • Change to date of revision
  • Change to section 4.2 - Posology and method of administration
  • 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 10 - Date of revision of the text
Active Ingredients: Pneumococcal polysaccharide conjugate vaccine
  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to further information section
  • Change to date of revision
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text
Active Ingredients: Trimetazidine dihydrochloride
  • Addition of black triangle
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to date of revision
  • Change to MA holder contact details, Addition of information on reporting a side effect.
19 September 2014
New 2, Updated 6, Retired 0, [Total 8]
Active Ingredients: Mecasermin
  • Addition of black triangle
  • Change to section 4.8 - Undesirable effects
Active Ingredients: Erythromycin, Isotretinoin
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • 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 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text
Active Ingredients: Meningococcal Group A, C, W135 and Y conjugate vaccine
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Active Ingredients: Betahistine dihydrochloride
  • Change to further information section
  • Change to date of revision
  • Change to section 2 - Qualitative and quantitative composition
  • 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
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
Active Ingredients: Idelalisib
  • New PIL for new product
Active Ingredients: Idelalisib
  • New PIL for new product