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Document information 01/02/2015 04:04
Current documents
SPC 2425
PIL 1984
Total: 4409
Submissions in the last 3 months
Updated: 949
New: 53

 

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 January 2015
New 0, Updated 15, Retired 0, [Total 15]
Active Ingredients: Meningococcal group-B vaccine (rDNA, component, adsorbed)
  • Change to warnings or special precautions for use
  • Change to side-effects
Active Ingredients: Bisoprolol Fumarate
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.4 - Special precautions for storage
Active Ingredients: Certolizumab Pegol
  • Change of trade or active ingredient name
  • Change to section 4.3 - Contraindications
  • 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: Leuprorelin Acetate
  • Change to storage instructions
  • Change to date of revision, Addition of information on reporting a side effect.
Active Ingredients: Leuprorelin Acetate
  • Change to storage instructions
  • Change to date of revision, Addition of information on reporting a side effect.
Active Ingredients: Leuprorelin Acetate
  • Change to storage instructions
  • Change to date of revision, Addition of information on reporting a side effect.
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text
Active Ingredients: Dabigatran etexilate mesilate
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text
Active Ingredients: Dabigatran etexilate mesilate
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text
Active Ingredients: Dabigatran etexilate mesilate
  • 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 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text
Active Ingredients: Eltrombopag olamine
  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to instructions about missed dose
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision
  • Change to dosage and administration, Addition of information on reporting a side effect.
Active Ingredients: Remifentanil Hydrochloride
  • Change to, or new use for medicine
  • Change to date of revision
Active Ingredients: Remifentanil Hydrochloride
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
Active Ingredients: enzalutamide
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision
29 January 2015
New 0, Updated 13, Retired 2, [Total 15]
  • Change to warnings or special precautions for use, Addition of information on reporting a side effect.
  • 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to warnings or special precautions for use, Addition of information on reporting a side effect.
Active Ingredients: Paracetamol, Pholcodine, Pseudoephedrine Hydrochloride
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.3 - Preclinical safety data
Active Ingredients: Fluconazole
  • Change to section 5.3 - Preclinical safety data
Active Ingredients: Telaprevir
  • Change to, or new use for medicine
  • Change to date of revision
Active Ingredients: Lormetazepam
  • Change to side-effects
  • Change to date of revision
Active Ingredients: Norethisterone
  • Change to side-effects
  • Change to date of revision
Active Ingredients: Sofosbuvir
  • Change to date of revision
Active Ingredients: Indacaterol maleate , Glycopyrronium bromide
  • Change to section 7 - Marketing authorisation holder
SPC retired Voltarol 75mg/3ml ampoules
Active Ingredients: Diclofenac Sodium
  • Product no longer marketed in Ireland
PIL retired Voltarol 75mg/3ml ampoules
Active Ingredients: Diclofenac Sodium
  • PIL - Product no longer marketed in Ireland
  • Change to warnings or special precautions for use
  • Change to date of revision
28 January 2015
New 0, Updated 20, Retired 0, [Total 20]
Active Ingredients: Amphotericin B
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Active Ingredients: Bisoprolol Fumarate
  • Change to storage instructions
  • Change to side-effects
  • Change to further information section
  • Change to date of revision
  • Change to section 5.3 - Preclinical safety data
  • Change to section 5.3 - Preclinical safety data
Active Ingredients: Fluconazole
  • Change to section 5.3 - Preclinical safety data
Active Ingredients: Fluconazole
  • Change to section 5.3 - Preclinical safety data
Active Ingredients: Ulipristal acetate
  • Change to section 10 - Date of revision of the text, Addition of legal category
Active Ingredients: Hydrochlorothiazide, Enalapril Maleate
  • 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 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • 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: Filgrastim
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
Active Ingredients: Lormetazepam
  • 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: Norethisterone
  • 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: Denosumab
  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
Active Ingredients: Cinchocaine hydrochloride, prednisolone caproate
  • Change to side-effects
Active Ingredients: Cinchocaine hydrochloride, prednisolone caproate
  • 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: Tiotropium bromide monohydrate
  • Change to section 1 - Name of medicinal product
  • Change to section 3 - Pharmaceutical form
  • 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 4.9 - Overdose
  • 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: Regorafenib
  • Change to side-effects
Active Ingredients: Tenofovir disoproxil fumarate, Emtricitabine
  • Change to date of revision, Introduction of new pack/pack size
Active Ingredients: Rivaroxaban
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
Active Ingredients: Rivaroxaban
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties