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Document information 18/12/2017 22:05
Current documents
SPC 2624
PIL 2177
Total: 4801
Submissions in the last 3 months
Updated: 888
New: 55

 

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
18 December 2017
New 0, Updated 17, Retired 0, [Total 17]
Active Ingredients: hyoscine butylbromide
  • Change to section 4.3 - Contraindications
  • Change to section 10 - Date of revision of the text
Active Ingredients: hyoscine butylbromide
  • Change to section 4.3 - Contraindications
  • Change to section 10 - Date of revision of the text
  • Change to section 3 - how to take/use
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision
Active Ingredients: Perindopril arginine
  • Change to section 6 - what the product looks like and pack contents
Active Ingredients: Perindopril arginine
  • Change to section 6 - what the product looks like and pack contents
Active Ingredients: Calcipotriol
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - excipient warnings
  • Change to section 3 - how to take/use
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision, Correction of spelling/typing errors, Improved presentation of PIL
Active Ingredients: Ulipristal acetate
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Improved presentation of PIL
  • Improved presentation of PIL
  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Change to Section 1 - what the product is
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
Active Ingredients: Cladribine
Company: Merck | Document History
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects, Removal of black triangle
  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
15 December 2017
New 0, Updated 12, Retired 0, [Total 12]
Active Ingredients: Levodopa, Carbidopa Monohydrate
  • 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
  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
  • 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
  • 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
Active Ingredients: Teriparatide
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text, Improved presentation of SPC
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
  • 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
Active Ingredients: Cyanocobalamin (Vitamin B12), Ferrous sulfate, Vitamin A, Folic Acid, Zinc sulfate monohydrate, Colecalciferol (Vitamin D3), Ascorbic Acid (Vitamin C), Riboflavine (Vitamin B2), Nicotinamide, Magnesium sulfate, Lecithin, Vitamin E (tocopherol), Biotin, pyridoxine hydrochloride (B6), thiamine mononitrate (B1), Ginseng extract, Calcium phosphate, anhydrous, dibasic, Copper sulfate, sodium selenite
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
  • Change to section 4.2 - Posology and method of administration
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
Active Ingredients: Fluticasone Propionate, Salmeterol Xinafoate
  • Change to section 2 - excipient warnings
  • Change to section 6 - date of revision
Active Ingredients: Fluticasone Propionate, Salmeterol Xinafoate
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text
Active Ingredients: Collagenase clostridium histolyticum
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
14 December 2017
New 0, Updated 16, Retired 0, [Total 16]
  • Change to section 6 - date of revision
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 10 - Date of revision of the text
Active Ingredients: hyoscine butylbromide
  • Change to section 2 - what you need to know - contraindications
  • Change to section 6 - date of revision
Active Ingredients: hyoscine butylbromide
  • Change to section 2 - what you need to know - contraindications
  • Change to section 6 - date of revision
Active Ingredients: Eliglustat tartrate
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 4.4 - Special warnings and precautions for use, Improved presentation of SPC
Active Ingredients: Esomeprazole magnesium trihydrate
  • 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 7 - Marketing authorisation holder
  • Change to section 6 - what the product contains
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals
Active Ingredients: Cinnarizine
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
Active Ingredients: Hydrochlorothiazide, Eprosartan mesilate
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
Active Ingredients: Tenofovir alafenamide fumarate
  • Change to section 3 - how to take/use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 7 - Marketing authorisation holder