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Document information 27/03/2015 01:52
Current documents
SPC 2444
PIL 1994
Total: 4438
Submissions in the last 3 months
Updated: 960
New: 62

 

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
26 March 2015
New 2, Updated 20, Retired 2, [Total 24]
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Change to further information section
  • Change to further information section
  • Change to further information section
  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Active Ingredients: Fluticasone Propionate
  • Change to side-effects
  • Change to date of revision
Active Ingredients: Fluticasone Propionate
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Active Ingredients: Fluticasone Propionate
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Active Ingredients: Fluticasone Propionate
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Active Ingredients: Fluticasone Propionate
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Active Ingredients: Fluticasone Propionate
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Active Ingredients: Fluticasone Propionate
  • Change to side-effects
  • Change to date of revision
Active Ingredients: Fluticasone Propionate
  • Change to side-effects
  • Change to date of revision
Active Ingredients: Fluticasone Propionate
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Active Ingredients: Fluticasone Propionate
  • Change to side-effects
  • Change to date of revision
Active Ingredients: Influenza vaccine (surface antigen, inactivated)
  • Change to further information section
  • Change to date of revision, Addition of information on reporting a side effect.
Active Ingredients: Meptazinol hydrochloride
  • Addition of information on reporting a side effect.
Active Ingredients: Meptazinol hydrochloride
  • Addition of information on reporting a side effect.
PIL retired Roferon-A Cartridge
Active Ingredients: Interferon Alfa-2a
  • Licence Withdrawn
SPC retired Roferon-A Cartridge
Active Ingredients: Interferon Alfa-2a
  • Licence Withdrawn
Active Ingredients: Salmeterol Xinafoate
  • Change to date of revision
  • Change to marketing authorisation holder
Active Ingredients: Salmeterol Xinafoate
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Active Ingredients: Zopiclone
Company: Chiesi Limited
  • New individual SPC (was previously included in combined SPC)
Active Ingredients: Zopiclone
Company: Chiesi Limited
  • New individual SPC (was previously included in combined SPC)
25 March 2015
New 0, Updated 13, Retired 0, [Total 13]
Active Ingredients: citalopram hydrochloride
  • 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: citalopram hydrobromide
  • 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 10 - Date of revision of the text
  • Change to side-effects
  • Change to side-effects
  • Change to side-effects
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Active Ingredients: Ibrutinib
  • Change to warnings or special precautions for use
  • Change to side-effects
Active Ingredients: Midodrine Hydrochloride
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.3 - Contraindications
  • 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 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
Active Ingredients: Midodrine Hydrochloride
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to further information section
  • Change to date of revision
Active Ingredients: Levofloxacin hemihydrate
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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, Correction of spelling/typing errors
Active Ingredients: Zopiclone
  • Change to date of revision, Addition of information on reporting a side effect.
24 March 2015
New 1, Updated 17, Retired 0, [Total 18]
Active Ingredients: Zoledronic acid monohydrate
  • Change to section 7 - Marketing authorisation holder
  • Change to MA holder contact details
Active Ingredients: Alteplase
  • 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 4.3 - 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • 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
  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Active Ingredients: Ibuprofen, Pseudoephedrine Hydrochloride
  • Change to section 2 - Qualitative and quantitative composition
  • 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 10 - Date of revision of the text
Active Ingredients: Ibuprofen, Pseudoephedrine Hydrochloride
  • Change to date of revision
  • Change to improve clarity and readability
  • New PIL for new product
  • Change to section 1 - Name of medicinal product
  • 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 4.5 - 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
  • Change to date of revision
  • Change to marketing authorisation holder
  • Change to MA holder contact details
Active Ingredients: Fluvastatin sodium
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Active Ingredients: Midodrine Hydrochloride
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to further information section
  • Change to date of revision
Active Ingredients: Midodrine Hydrochloride
  • 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 4.5 - 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 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
Active Ingredients: Calcium Carbonate, Magnesium carbonate, heavy
  • 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: Lanreotide acetate
  • Changes to therapeutic indications
  • Change to section 5.1 - Pharmacodynamic properties
Active Ingredients: Valaciclovir hydrochloride
  • 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: Valaciclovir hydrochloride
  • 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: Nintedanib esilate
  • Change to further information section
  • Change to date of revision
Active Ingredients: Nintedanib esilate
  • Change to storage instructions
  • Change to further information section
  • Change to date of revision