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Document information 06/03/2015 03:56
Current documents
SPC 2435
PIL 1994
Total: 4429
Submissions in the last 3 months
Updated: 951
New: 70

 

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
05 March 2015
New 1, Updated 9, Retired 2, [Total 12]
  • 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
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to side-effects
Active Ingredients: Salicylic Acid, Coconut Oil, Distilled Coal Tar
  • Change to date of revision, Addition of information on reporting a side effect.
Active Ingredients: Salicylic Acid, Coconut Oil, Distilled Coal Tar
  • 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: Rasburicase
  • Change to side-effects
  • Change to date of revision
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • 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 date of revision
Active Ingredients: Sevelamer hydrochloride
  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to instructions about missed dose
  • Change to instructions about overdose
  • Change to side-effects
  • Change to drug interactions
  • Change to information about drinking alcohol
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to date of revision
  • New PIL for medicines.ie
PIL retired Revlimid 2.5mg, 5mg, 10mg
Active Ingredients: Lenalidomide
Company: Celgene Ltd
  • Individual presentations superseded by joint PIL
PIL retired Revlimid 7.5mg, 15mg, 25mg
Active Ingredients: Lenalidomide
Company: Celgene Ltd
  • Individual presentations superseded by joint PIL
  • Change of inactive ingredient
  • Change to packaging
  • Change to, or new use for medicine
  • Change to date of revision, Correction of spelling/typing errors
04 March 2015
New 1, Updated 18, Retired 0, [Total 19]
Active Ingredients: Hydrocortisone & urea
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
Active Ingredients: Caffeine, Acetylsalicylic acid (Aspirin)
  • Addition of information on reporting a side effect.
  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to instructions about missed dose
  • Change to instructions about overdose
  • Change to storage instructions
  • Change to side-effects
  • Change to information about drinking alcohol
  • 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
  • Change to dosage and administration, Addition of manufacturer
  • Addition of information on reporting a side effect.
  • Change to side-effects
  • Change to date of revision
Active Ingredients: Enalapril Maleate, Lercanidipine Hydrochloride
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to date of revision
Active Ingredients: Enalapril Maleate, Lercanidipine Hydrochloride
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to date of revision
Active Ingredients: Meloxicam
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to further information section
  • Change to date of revision
  • Change to dosage and administration
  • Change to improve clarity and readability, Addition of information on reporting a side effect.
Active Ingredients: Meloxicam
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to further information section
  • Change to date of revision
  • Change to dosage and administration
  • Change to improve clarity and readability, Addition of information on reporting a side effect.
Active Ingredients: Naltrexone Hydrochloride
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
Active Ingredients: Ciclosporin
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
  • Change to side-effects
Active Ingredients: Ciclosporin
  • Change to section 4.8 - Undesirable effects
  • 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: Ciclosporin
  • Change to section 4.8 - Undesirable effects
  • 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: Ciclosporin
  • Change to side-effects
Active Ingredients: Nicotinamide
  • Change to further information section
  • Change to date of revision, Addition of information on reporting a side effect., Removal/change of distributor
Active Ingredients: Teduglutide
  • New SPC for new product
Active Ingredients: Botulinum Toxin Type A
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
03 March 2015
New 1, Updated 13, Retired 0, [Total 14]
Active Ingredients: Chlorphenamine Maleate
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors
Active Ingredients: Hydrochlorothiazide, Valsartan, Amlodipine besylate
  • Change to section 7 - Marketing authorisation holder
Active Ingredients: Hydrochlorothiazide, Valsartan, Amlodipine besylate
  • Change to section 7 - Marketing authorisation holder
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • Change to side-effects
  • Change to date of revision
  • Change to side-effects
  • Change to date of revision
Active Ingredients: Ethinyloestradiol, Desogestrel
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Active Ingredients: Teduglutide
  • New PIL for new product
Active Ingredients: Estradiol Hemihydrate
  • Change to date of revision, Addition of information on reporting a side effect.
Active Ingredients: Estradiol Hemihydrate
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Active Ingredients: azacitidine
  • Change to side-effects