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Document information 25/10/2014 19:54
Current documents
SPC 2404
PIL 1993
Total: 4397
Submissions in the last 3 months
Updated: 979
New: 85

 

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
25 October 2014
New 0, Updated 2, Retired 0, [Total 2]
Active Ingredients: Paracetamol, Caffeine, Codeine Phosphate Hemihydrate
  • Change to section 10 - Date of revision of the text
Active Ingredients: Paracetamol, Caffeine, Codeine Phosphate Hemihydrate
  • Change to section 10 - Date of revision of the text
24 October 2014
New 0, Updated 12, Retired 0, [Total 12]
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 10 - Date of revision of the text
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 10 - Date of revision of the text
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 10 - Date of revision of the text
Active Ingredients: Fluticasone Propionate, Azelastine Hydrochloride
  • Correction of spelling/typing errors
Active Ingredients: Metformin Hydrochloride, Saxagliptin hydrochloride
  • Change to date of revision
  • Change to marketing authorisation holder
Active Ingredients: Metformin Hydrochloride, Saxagliptin hydrochloride
  • Change to date of revision
  • Change to marketing authorisation holder
  • Change to date of revision
  • Change to marketing authorisation holder
  • Improved electronic presentation
Active Ingredients: Rimexolone 10mg/ml
  • 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.2 - Pharmacokinetic properties
23 October 2014
New 10, Updated 13, Retired 0, [Total 23]
Active Ingredients: Adapalene
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to date of revision, Addition of information on reporting a side effect.
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.5 - Nature and contents of container
Active Ingredients: Somatropin
  • Change to section 4.3 - Contraindications
  • Change to section 4.8 - Undesirable effects
Active Ingredients: Somatropin
  • New individual SPC (was previously included in combined SPC)
Active Ingredients: Somatropin
  • New individual SPC (was previously included in combined SPC)
Active Ingredients: Somatropin
  • New individual SPC (was previously included in combined SPC)
Active Ingredients: Somatropin
  • New individual SPC (was previously included in combined SPC)
Active Ingredients: Somatropin
  • New individual SPC (was previously included in combined SPC)
Active Ingredients: Somatropin
  • New individual SPC (was previously included in combined SPC)
Active Ingredients: Somatropin
  • New individual SPC (was previously included in combined SPC)
Active Ingredients: Somatropin
  • New individual SPC (was previously included in combined SPC)
Active Ingredients: Somatropin
  • New individual SPC (was previously included in combined SPC)
Active Ingredients: Ketamine Hydrochloride
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4 - Clinical particulars
  • 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 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 8 - MA number
  • Change to section 1 - Name of medicinal product
  • 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 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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
  • Change to section 3 - Pharmaceutical form
  • 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 10 - Date of revision of the text
Active Ingredients: Lamotrigine
  • New PIL for new product
  • Change to MA holder contact details
Active Ingredients: Prednisolone Acetate
  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
Active Ingredients: Prednisolone Acetate
  • Change of contraindications
  • Change to instructions about missed dose
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to further information section
  • Change to date of revision
Active Ingredients: Ziconotide acetate
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.3 - Shelf life
  • 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, Correction of spelling/typing errors
  • Change to improve clarity and readability
  • Change due to harmonisation of SPC
Active Ingredients: 5.5mg fibrinogen, 2.0IU thrombin/cm2
  • Change to date of revision, Introduction of new pack/pack size
  • Change to product name, Addition of information on reporting a side effect.
Active Ingredients: 5.5mg fibrinogen, 2.0IU thrombin/cm2
  • Change to section 1 - Name of medicinal product
  • Change to section 3 - Pharmaceutical form
  • 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 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
Active Ingredients: Fesoterodine Fumarate
  • Change to section 10 - Date of revision of the text, Improved electronic presentation