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Document information 21/10/2014 09:44
Current documents
SPC 2394
PIL 1992
Total: 4386
Submissions in the last 3 months
Updated: 1000
New: 72

 

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
21 October 2014
New 0, Updated 5, Retired 0, [Total 5]
Active Ingredients: Enalapril Maleate, Lercanidipine Hydrochloride
  • Change to section 10 - Date of revision of the text, Correction of spelling/typing errors
Active Ingredients: Enalapril Maleate, Lercanidipine Hydrochloride
  • Change to section 10 - Date of revision of the text, Correction of spelling/typing errors
Active Ingredients: Flavoxate 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: Silodosin
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Active Ingredients: Silodosin
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
20 October 2014
New 0, Updated 7, Retired 0, [Total 7]
Active Ingredients: Botulinum Toxin Type A
  • 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 4.8 - 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 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
Active Ingredients: Botulinum Toxin Type A
  • 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 4.8 - 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 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
SPC updated FML
Active Ingredients: Fluorometholone
  • 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 10 - Date of revision of the text
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text, Introduction of new pack/pack size
Active Ingredients: Ethinyloestradiol, Gestodene
  • Change to section 4.8 - Undesirable effects
Active Ingredients: Levonorgestrel
  • 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 4.7 - 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text, Correction of spelling/typing errors
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
17 October 2014
New 0, Updated 11, Retired 4, [Total 15]
Active Ingredients: Hydrochlorothiazide, Candesartan Cilexetil
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
PIL retired Blopress Plus 16mg/12.5mg tablets
Active Ingredients: Hydrochlorothiazide, Candesartan Cilexetil
  • Change to marketing authorisation holder address,Individual presentations superseded by joint PIL
Active Ingredients: Hydrochlorothiazide, Candesartan Cilexetil
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Active Ingredients: Hydrochlorothiazide, Candesartan Cilexetil
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
PIL retired Blopress Plus 32 mg/25 mg tablets
Active Ingredients: Hydrochlorothiazide, Candesartan Cilexetil
  • Change to marketing authorisation holder address,Individual presentations superseded by joint PIL
PIL retired Blopress Plus 32mg/12.5mg tablets
Active Ingredients: Hydrochlorothiazide, Candesartan Cilexetil
  • Change to marketing authorisation holder address,Individual presentations superseded by joint PIL
Active Ingredients: Hydrochlorothiazide, Candesartan Cilexetil
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
PIL retired Blopress Plus 8mg/12.5mg tablets
Active Ingredients: Hydrochlorothiazide, Candesartan Cilexetil
  • Change to marketing authorisation holder address,Individual presentations superseded by joint PIL
Active Ingredients: Candesartan Cilexetil
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
  • Change to further information section
  • Change to date of revision
Active Ingredients: Lenalidomide
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.2 - Pharmacokinetic properties
  • 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 4.6 - 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 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • 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 4.6 - 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 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • 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 4.6 - 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 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • 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 4.6 - 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 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data