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Document information 25/07/2016 01:17
Current documents
SPC 2557
PIL 2136
Total: 4693
Submissions in the last 3 months
Updated: 896
New: 91

 

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
22 July 2016
New 0, Updated 22, Retired 3, [Total 25]
  • Change to section 4.3 - Contraindications
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 4.3 - Contraindications
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 4.3 - Contraindications
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 4.3 - Contraindications
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 4.3 - Contraindications
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to date of revision
Active Ingredients: Hydrochlorothiazide, olmesartan medoxomil
  • Change to storage instructions
  • Change to date of revision
Active Ingredients: Cobimetinib hemifumarate
  • Change to date of revision, Correction of spelling/typing errors
  • 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 4.8 - Undesirable effects
  • Change to section 9 - Date of renewal of authorisation
Active Ingredients: Medroxyprogesterone Acetate, Estradiol valerate
  • Change of manufacturer
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
PIL retired Naprosyn EC 250mg and 500mg Gastro-resistant Tablets
Active Ingredients: Naproxen
  • Licence Withdrawn
SPC retired Naprosyn EC 250mg Gastro-resistant Tablets
Active Ingredients: Naproxen
  • Licence Withdrawn
SPC retired Naprosyn EC 500mg Gastro-resistant Tablets
Active Ingredients: Naproxen
  • Licence Withdrawn
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Active Ingredients: Apremilast
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Active Ingredients: Conjugated oestrogens
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
Active Ingredients: Somatropin
Company: Merck | Document History
  • Change to side-effects
  • Change to how the medicine works
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to date of revision
Active Ingredients: Thalidomide
  • Change to side-effects
  • Change to date of revision
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text
  • Change to improve clarity and readability
Active Ingredients: Botulinum Toxin Type A
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.8 - Undesirable effects
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Active Ingredients: Botulinum Toxin Type A
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.8 - Undesirable effects
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Active Ingredients: Cetirizine Dihydrochloride, Pseudoephedrine Hydrochloride
  • Deletion of a pack size, Introduction of new pack/pack size
21 July 2016
New 0, Updated 10, Retired 0, [Total 10]
  • Change of contraindications
Active Ingredients: Amoxicillin trihydrate, Potassium clavulanate
  • Change to further information section
  • Change to date of revision
  • Change to improve clarity and readability
  • 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 4.8 - Undesirable effects
  • Change to section 9 - Date of renewal of authorisation
  • 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 4.8 - Undesirable effects
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • Change to further information section
  • Change to date of revision
Active Ingredients: Ruxolitinib Phosphate
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • Change of inactive ingredient
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to how the medicine works
  • Change to date of revision
  • Change to side-effects
  • Change to information about driving or using machinery
  • Change to further information section
  • Change to date of revision, Addition of joint PIL covering all presentations
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Change to dosage and administration
20 July 2016
New 0, Updated 12, Retired 0, [Total 12]
Active Ingredients: Japanese encephalitis vaccine (inactivated, adsorbed)
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Active Ingredients: Apremilast
  • Change to side-effects
  • Change to date of revision
  • Change to name of manufacturer
  • Change to MA holder contact details
  • Change to name of manufacturer
Active Ingredients: Methadone Hydrochloride
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
Active Ingredients: Methadone Hydrochloride
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Active Ingredients: Regorafenib
  • Change to section 4.8 - Undesirable effects
Active Ingredients: Regorafenib
  • Change to warnings or special precautions for use
  • Change to date of revision
  • Change to MA holder contact details
  • Change to date of revision
  • Change to appearance of the medicine
Active Ingredients: Rivaroxaban
  • 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: Rivaroxaban
  • 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