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Document information 10/02/2016 10:39
Current documents
SPC 2532
PIL 2070
Total: 4602
Submissions in the last 3 months
Updated: 1009
New: 83

 

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
10 February 2016
New 0, Updated 9, Retired 2, [Total 11]
PIL retired Codalax and Codalax Forte Capsules
Active Ingredients: Poloxamer 188, Dantron
  • Licence Withdrawn
SPC retired Codalax and Codalax Forte Capsules
Active Ingredients: Poloxamer 188, Dantron
  • Licence Withdrawn
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
Active Ingredients: Potassium Chloride
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
  • Change to side-effects
  • Change to date of revision
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision
  • Improved electronic presentation
  • Improved electronic presentation
09 February 2016
New 0, Updated 16, Retired 2, [Total 18]
Active Ingredients: Irinotecan hydrochloride trihydrate
  • Change to section 6.3 - Shelf life
Active Ingredients: venlafaxine hydrochloride
  • Change to section 9 - Date of renewal of authorisation
Active Ingredients: venlafaxine hydrochloride
  • Change to section 9 - Date of renewal of authorisation
Active Ingredients: venlafaxine hydrochloride
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
Active Ingredients: Lamivudine, Abacavir Sulfate
  • 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: Bimatoprost
  • Previous version of SPC reinstated
Active Ingredients: Bimatoprost
  • Previous version of SPC reinstated
Active Ingredients: Levothyroxine sodium
Company: Aspen | Document History
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to how the medicine works
  • Change to further information section
  • Change to date of revision
  • Change to marketing authorisation holder
  • Change to MA holder contact details
  • Change to product name
Active Ingredients: Dabigatran etexilate mesilate
  • Change to date of revision
  • Change to improve clarity and readability
Active Ingredients: Dabigatran etexilate mesilate
  • Change to date of revision
  • Change to improve clarity and readability
SPC retired Rocaltrol 0.25mcg Soft Capsules
Active Ingredients: Calcitriol
  • Licence Withdrawn
PIL retired Rocaltrol 0.25mcg Soft Capsules
Active Ingredients: Calcitriol
  • Licence Withdrawn
Active Ingredients: Lamivudine, Abacavir Sulfate, Dolutegravir sodium
  • 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: Lamivudine, Zidovudine, Abacavir Sulfate
  • 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: Abacavir Sulfate
  • 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: Abacavir Sulfate
  • 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
08 February 2016
New 2, Updated 14, Retired 0, [Total 16]
Active Ingredients: Atenolol, Chlortalidone
  • New individual SPC (was previously included in combined SPC)
Active Ingredients: Atenolol, Chlortalidone
  • New individual SPC (was previously included in combined SPC)
Active Ingredients: follitropin alfa
  • Change to date of revision
Active Ingredients: follitropin alfa
  • Change to date of revision
Active Ingredients: follitropin alfa
  • Change to date of revision
Active Ingredients: Lamivudine, Abacavir Sulfate
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
Active Ingredients: mefloquine hydrochloride
  • Change to section 3 - Pharmaceutical form
  • 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 10 - Date of revision of the text
Active Ingredients: Bimatoprost
  • Previous version of PIL reinstated
Active Ingredients: Ethinyloestradiol, Levonorgestrel
  • 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 pregnancy or lactation
  • Change to information about driving or using machinery
  • 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 4.1 - 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
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 6.6 - Special precautions for disposal and other handling
  • Change to section 8 - MA number
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
Active Ingredients: Sofosbuvir
  • 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 10 - Date of revision of the text
Active Ingredients: Lamivudine, Abacavir Sulfate, Dolutegravir sodium
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
Active Ingredients: Lamivudine, Zidovudine, Abacavir Sulfate
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
Active Ingredients: Abacavir Sulfate
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
Active Ingredients: Abacavir Sulfate
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision