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Document information 01/08/2014 08:47
Current documents
SPC 2387
PIL 1987
Total: 4374
Submissions in the last 3 months
Updated: 1027
New: 49

 

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
31 July 2014
New 0, Updated 17, Retired 0, [Total 17]
Active Ingredients: Amlodipine besilate
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text, Introduction of new pack/pack size
Active Ingredients: Tenofovir disoproxil fumarate, Efavirenz, Emtricitabine
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 10 - Date of revision of the text
Active Ingredients: Prazepam
  • Change to side-effects
  • Change to further information section
  • Change to date of revision
  • Change to improve clarity and readability, Deletion of a pack size, Improved electronic presentation
Active Ingredients: Dorzolamide Hydrochloride, Timolol Maleate
  • Change to date of revision
  • Change to MA holder contact details
  • Change to improve clarity and readability, Addition of information on reporting a side effect.
  • Change to side-effects
Active Ingredients: Sodium Alginate, Potassium hydrogen carbonate
  • Change to packaging
Active Ingredients: Metformin Hydrochloride, sitagliptin phosphate monohydrate
  • Introduction of new pack/pack size
Active Ingredients: sitagliptin phosphate monohydrate
  • Addition of information on reporting a side effect.
Active Ingredients: sitagliptin phosphate monohydrate
  • Addition of information on reporting a side effect.
Active Ingredients: pregabalin
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to product name
  • Change to section 1 - Name of medicinal product
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text, Introduction of new pack/pack size
  • Change to section 4.8 - Undesirable effects
Active Ingredients: Desloratadine
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.8 - Undesirable effects
Active Ingredients: Sofosbuvir
  • Change to date of revision
Active Ingredients: Dolutegravir sodium
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.2 - Pharmacokinetic properties
Active Ingredients: Anagrelide hydrochloride
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.2 - Pharmacokinetic properties
30 July 2014
New 3, Updated 36, Retired 0, [Total 39]
Active Ingredients: brimonidine tartrate
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
Active Ingredients: Teriflunomide
  • New SPC for new product
Active Ingredients: duloxetine hydrochloride
  • Change to section 4.2 - Posology and method of administration
  • 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 10 - Date of revision of the text
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
Active Ingredients: Vildagliptin
  • Change to warnings or special precautions for use
  • Change to side-effects, Addition of information on reporting a side effect.
Active Ingredients: follitropin alfa
  • Addition of information on reporting a side effect.
Active Ingredients: follitropin alfa
  • Addition of information on reporting a side effect.
Active Ingredients: follitropin alfa
  • Addition of information on reporting a side effect.
Active Ingredients: follitropin alfa
  • Addition of information on reporting a side effect.
Active Ingredients: follitropin alfa
  • Addition of information on reporting a side effect.
Active Ingredients: follitropin alfa
  • Addition of information on reporting a side effect.
Active Ingredients: Pomalidomide
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • New SPC for new product
  • New PIL for new product
  • 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 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 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 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 - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • 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 4.9 - Overdose
  • 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 side-effects
  • Change to information about pregnancy or lactation
  • Change to further information section
  • Change to date of revision, Addition of information on reporting a side effect., Correction of spelling/typing errors
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and lactation
  • 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 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Active Ingredients: Interferon beta-1a
  • Change to warnings or special precautions for use
  • Change to side-effects, Addition of information on reporting a side effect.
Active Ingredients: Interferon beta-1a
  • Change to warnings or special precautions for use
  • Change to side-effects, Addition of information on reporting a side effect.
  • Change to warnings or special precautions for use
  • Change to side-effects, Addition of information on reporting a side effect.
Active Ingredients: Interferon beta-1a
  • Change to warnings or special precautions for use
  • Change to side-effects, Addition of information on reporting a side effect.
Active Ingredients: Interferon beta-1a
  • Change to warnings or special precautions for use
  • Change to side-effects, Addition of information on reporting a side effect.
  • Change to warnings or special precautions for use
  • Change to side-effects, Addition of information on reporting a side effect.
  • Change to side-effects, Addition of information on reporting a side effect.
  • Change to warnings or special precautions for use
  • Change to side-effects, Addition of information on reporting a side effect.
  • Change to warnings or special precautions for use
  • Change to side-effects, Addition of information on reporting a side effect.
Active Ingredients: Lenalidomide
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.1 - List of excipients
Active Ingredients: Itraconazole
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision
Active Ingredients: prochlorperazine mesilate
  • Change to side-effects
Active Ingredients: Prochlorperazine maleate
  • Change to side-effects
29 July 2014
New 8, Updated 16, Retired 2, [Total 26]
  • Change to date of revision
  • Change due to harmonisation of PIL, Addition of information on reporting a side effect.
  • 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 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
Active Ingredients: Teriflunomide
  • New PIL for new product
Active Ingredients: Beclometasone Dipropionate
  • New SPC for medicines.ie
Active Ingredients: Beclometasone Dipropionate
  • New SPC for medicines.ie
Active Ingredients: Beclometasone Dipropionate
  • New SPC for medicines.ie
  • Change to drug interactions
  • Change to date of revision
  • Change to dosage and administration, Addition of information on reporting a side effect., Correction of spelling/typing errors
  • Change to warnings or special precautions for use, Addition of information on reporting a side effect.
PIL retired Eliquis 2.5 mg film-coated tablets
Active Ingredients: apixaban
  • Individual presentations superseded by joint PIL
PIL retired Eliquis 5 mg film coated tablets
Active Ingredients: apixaban
  • Individual presentations superseded by joint PIL
Active Ingredients: Human Insulin
  • Change to date of revision
  • Change due to harmonisation of PIL, Addition of information on reporting a side effect.
Active Ingredients: Human Insulin
  • Change to date of revision
  • Change due to harmonisation of PIL, Addition of information on reporting a side effect.
Active Ingredients: Human Insulin
  • Change to date of revision
  • Change due to harmonisation of PIL, Addition of information on reporting a side effect.
  • 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 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
Active Ingredients: Canagliflozin hemihydrate
  • New PIL for new product
Active Ingredients: Canagliflozin hemihydrate
  • New SPC for new product
Active Ingredients: Canagliflozin hemihydrate
  • New SPC for new product
  • New PIL for new product
  • Change to section 6.5 - Nature and contents of container
  • Change to, or new use for medicine
  • Change to date of revision
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
Active Ingredients: Tretinoin, Clindamycin Phosphate
  • Change to product name
Active Ingredients: Paricalcitol
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
Active Ingredients: Abiraterone Acetate
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect