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Document information 17/12/2017 21:17
Current documents
SPC 2624
PIL 2177
Total: 4801
Submissions in the last 3 months
Updated: 885
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
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
13 December 2017
New 0, Updated 18, Retired 3, [Total 21]
  • Change to section 10 - Date of revision of the text
Active Ingredients: Leflunomide
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text
Active Ingredients: Leflunomide
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
Active Ingredients: Tamsulosin Hydrochloride, Dutasteride
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
Active Ingredients: Tamsulosin Hydrochloride, Dutasteride
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
PIL retired Copegus 200mg Film-coated Tablets
Active Ingredients: Ribavirin
  • Licence withdrawn
PIL retired Copegus 400 mg Film-coated Tablet
Active Ingredients: Ribavirin
  • Licence withdrawn
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text
Active Ingredients: Clobetasone Butyrate
  • 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: Clobetasone Butyrate
  • 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
Active Ingredients: Clobetasone Butyrate
  • 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
Active Ingredients: Clobetasone Butyrate
  • 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: Rasburicase
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
SPC retired Kevzara Combined
Active Ingredients: Sarilumab
Company: SANOFI
  • Retired from medicines.ie
Active Ingredients: pregabalin
  • Previous version of SPC reinstated
Active Ingredients: pregabalin
  • Previous version of SPC reinstated
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision
  • Change to section 6 - date of revision
  • Change to section 6 - date of revision