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Document information 27/11/2014 21:44
Current documents
SPC 2409
PIL 1989
Total: 4398
Submissions in the last 3 months
Updated: 1012
New: 68

 

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
27 November 2014
New 3, Updated 13, Retired 0, [Total 16]
Active Ingredients: Riociguat
  • Change to section 6.5 - Nature and contents of container
Active Ingredients: Riociguat
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
Active Ingredients: Riociguat
  • 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: Riociguat
  • 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: Riociguat
  • 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: Riociguat
  • Change to date of revision, Introduction of new pack/pack size, Addition of information on reporting a side effect.
Active Ingredients: Dibromopropamidine Isethionate
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text
Active Ingredients: Pomalidomide
Company: Celgene Ltd
  • New individual SPC (was previously included in combined SPC)
Active Ingredients: Pramipexole dihydrochloride monohydrate
  • Change to further information section
  • Change to date of revision, Addition of information on reporting a side effect.
  • 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: Lenalidomide
Company: Celgene Ltd
  • New individual SPC (was previously included in combined SPC)
Active Ingredients: Lenalidomide
Company: Celgene Ltd
  • New individual SPC (was previously included in combined SPC)
Active Ingredients: Itraconazole
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Change to side-effects
Active Ingredients: Paricalcitol
  • Change to section 4.2 - Posology and method of administration
26 November 2014
New 4, Updated 17, Retired 2, [Total 23]
Active Ingredients: Ciprofloxacin hydrochloride
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4 - Clinical particulars
  • 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5 - Pharmacological properties
  • 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 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Active Ingredients: Ciprofloxacin hydrochloride
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to instructions about missed dose
  • Change to instructions about overdose
  • Change to storage instructions
  • 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: Pomalidomide
  • Change to separate SPCs covering individual presentations
Active Ingredients: Pomalidomide
Company: Celgene Ltd
  • New individual SPC (was previously included in combined SPC)
Active Ingredients: Pomalidomide
Company: Celgene Ltd
  • New individual SPC (was previously included in combined SPC)
Active Ingredients: Ritonavir, Lopinavir
  • Change to instructions about overdose
  • Change to drug interactions
Active Ingredients: Ritonavir, Lopinavir
  • Change to instructions about missed dose
  • Change to drug interactions
Active Ingredients: Ritonavir, Lopinavir
  • Change to instructions about missed dose
  • Change to drug interactions
  • Change to warnings or special precautions for use
Active Ingredients: Levonorgestrel
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to how the medicine works
  • Change to date of revision
  • Change to dosage and administration
PIL retired Nurofen Advance Maximum Strength 400mg Oral Powder
Active Ingredients: Ibuprofen lysinate
  • PIL - Product no longer marketed in Ireland
SPC retired Nurofen Advance Maximum Strength 400mg Oral Powder
Active Ingredients: Ibuprofen lysinate
  • Product no longer marketed in Ireland
Active Ingredients: Lenalidomide
Company: Celgene Ltd
  • New individual SPC (was previously included in combined SPC)
Active Ingredients: Lenalidomide
  • Change to separate SPCs covering individual presentations
Active Ingredients: Lenalidomide
Company: Celgene Ltd
  • New individual SPC (was previously included in combined SPC)
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Active Ingredients: Ramipril
  • 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 4.8 - Undesirable effects
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
Active Ingredients: Ramipril
  • 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 4.8 - Undesirable effects
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
Active Ingredients: Ramipril
  • 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 4.8 - Undesirable effects
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
Active Ingredients: Ramipril
  • 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 4.8 - Undesirable effects
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
Active Ingredients: Paricalcitol
  • Change to warnings or special precautions for use
Active Ingredients: Paricalcitol
  • Change to warnings or special precautions for use
25 November 2014
New 0, Updated 19, Retired 0, [Total 19]
  • Change to warnings or special precautions for use
  • Change to information about driving or using machinery
  • Change to date of revision
  • Change to improve clarity and readability, Improved electronic presentation
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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 drug interactions
  • Change to date of revision
  • 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: Hydrochlorothiazide, olmesartan medoxomil, Amlodipine besilate
  • Change to drug interactions
  • Change to date of revision
  • 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: Lutropin alfa
  • Change to section 10 - Date of revision of the text
  • 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
  • Change to drug interactions
  • Change to date of revision
Active Ingredients: Hydrochlorothiazide, olmesartan medoxomil
  • 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: Hydrochlorothiazide, olmesartan medoxomil
  • Change to drug interactions
  • Change to date of revision
Active Ingredients: Hydrochlorothiazide, olmesartan medoxomil
  • 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: Hydrochlorothiazide, olmesartan medoxomil
  • Change to drug interactions
  • Change to date of revision
  • Change to date of revision
  • Change to improve clarity and readability, Addition of information on reporting a side effect.
  • Change to warnings or special precautions for use
  • Change to warnings or special precautions for use
Active Ingredients: enzalutamide
  • Addition of black triangle
Active Ingredients: Cetirizine Dihydrochloride, Pseudoephedrine Hydrochloride
  • Change to warnings or special precautions for use
  • Change to drug interactions, Addition of information on reporting a side effect.