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Document information 30/05/2016 11:40
Current documents
SPC 2548
PIL 2124
Total: 4672
Submissions in the last 3 months
Updated: 824
New: 75

 

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
30 May 2016
New 0, Updated 1, Retired 0, [Total 1]
Active Ingredients: Sodium Dihydrogen Phosphate Dihydrate, Disodium Phosphate Dodecahydrate
  • Change to section 1 - Name of medicinal product
  • Change to section 10 - Date of revision of the text
27 May 2016
New 0, Updated 19, Retired 0, [Total 19]
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.2 - Incompatibilities
  • 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
Active Ingredients: Levodopa, Carbidopa Monohydrate
  • 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 8 - MA number
  • Change to information about pregnancy or lactation
  • Change to date of revision
Active Ingredients: Ethinyloestradiol, Norelgestromin
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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: Hydrocortisone
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
Active Ingredients: Carfilzomib
  • 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: Carfilzomib
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
Active Ingredients: Paracetamol, Promethazine hydrochloride, Dextromethorphan Hydrobromide
  • Change to section 10 - Date of revision of the text
Active Ingredients: levomepromazine hydrochloride
  • Change to side-effects
  • Change to date of revision
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to dosage and administration
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to dosage and administration
Active Ingredients: Pantoprazole sodium sesquihydrate
  • 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: Medroxyprogesterone Acetate
  • Change to warnings or special precautions for use
  • Change to instructions about overdose
  • Change to storage instructions
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to further information section
  • Change to date of revision
  • Change to further information section
  • Change to date of revision
Active Ingredients: oseltamivir phosphate
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
  • Change to section 4.2 - Posology and method of administration
  • 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: Ethosuximide
  • Change to warnings or special precautions for use
  • Change to date of revision
26 May 2016
New 2, Updated 11, Retired 0, [Total 13]
Active Ingredients: Doxorubicin hydrochloride
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • Change to section 8 - MA number
Active Ingredients: Levodopa, Carbidopa Monohydrate
  • Change to warnings or special precautions for use
  • Change to side-effects
Active Ingredients: Ethinyloestradiol, Norelgestromin
  • Change to drug interactions
  • Change to date of revision
Active Ingredients: Dapagliflozin propanediol monohydrate
  • Change to section 4.4 - Special warnings and precautions for use
  • 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
  • Introduction of new strength
  • Introduction of new strength
Active Ingredients: Ivabradine hydrochloride
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
Active Ingredients: Pantoprazole sodium sesquihydrate
  • 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: Hydrochlorothiazide, Eprosartan mesilate
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to further information section
  • Change to date of revision
Active Ingredients: Lisinopril dihydrate
  • 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 10 - Date of revision of the text