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Document information 19/04/2014 11:43
Current documents
SPC 2383
PIL 1980
Total: 4363
Submissions in the last 3 months
Updated: 964
New: 61

 

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
18 April 2014
New 2, Updated 2, Retired 0, [Total 4]
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
Active Ingredients: Tamsulosin Hydrochloride
  • 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
  • New SPC for new product
  • New SPC for new product
17 April 2014
New 1, Updated 26, Retired 1, [Total 28]
  • 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: Sodium Alginate, Calcium Carbonate, Sodium Bicarbonate
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • 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 10 - Date of revision of the text
  • 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 10 - Date of revision of the text
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to date of revision
Active Ingredients: Saquinavir mesilate
  • Change to warnings or special precautions for use
  • Change to date of revision
  • Change to storage instructions
  • Addition of information on reporting a side effect.
PIL retired Panadol Tablets 500mg
Active Ingredients: Paracetamol
  • PIL Submitted in error
Active Ingredients: Pantoprazole sodium sesquihydrate
  • 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 5.1 - Pharmacodynamic properties
  • 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: Interferon beta-1a
  • Change to side-effects
  • Change to dosage and administration
  • Change of distributor details
Active Ingredients: Interferon beta-1a
  • Change to side-effects
  • Change to dosage and administration
  • Change of distributor details
  • Change to side-effects
  • Change to dosage and administration
  • Change of distributor details
Active Ingredients: Interferon beta-1a
  • Change to side-effects
  • Change to dosage and administration
  • Change of distributor details
Active Ingredients: Interferon beta-1a
  • Change to side-effects
  • Change to dosage and administration
  • Change of distributor details
  • Change to side-effects
  • Change to dosage and administration
  • Change of distributor details
  • Change to side-effects
  • Change to dosage and administration
  • Change of distributor details
  • Change to side-effects
  • Change to dosage and administration
  • Change of distributor details
  • Change to side-effects
  • Change to dosage and administration
  • Change of distributor details
  • Change to date of revision
  • Changes to therapeutic indications
  • Change to date of revision
  • Changes to therapeutic indications
Active Ingredients: Dimethyl fumarate
Company: Biogen Idec Ltd
  • New PIL for new product
  • 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 10 - Date of revision of the text
Active Ingredients: Tramadol Hydrochloride
  • Addition of information on reporting a side effect.
Active Ingredients: Tramadol Hydrochloride
  • Addition of information on reporting a side effect.
Active Ingredients: Tramadol Hydrochloride
  • Addition of information on reporting a side effect.
16 April 2014
New 3, Updated 14, Retired 0, [Total 17]
  • Change to date of revision
  • Change to MA holder contact details
Active Ingredients: Doxycycline monohydrate
  • Change to side-effects, Addition of information on reporting a side effect.
Active Ingredients: human papillomavirus vaccine
  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to information about pregnancy or lactation
  • Change to date of revision, Addition of information on reporting a side effect.
Active Ingredients: Sodium Alginate, Potassium hydrogen carbonate
  • New PIL for medicines.ie
Active Ingredients: Telaprevir
  • Change to further information section
  • Change to date of revision
Active Ingredients: Telaprevir
  • Change to section 4.2 - Posology and method of administration
  • 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
  • Change to side-effects
  • Change to drug interactions, Addition of manufacturer, Addition of information on reporting a side effect.
Active Ingredients: verapamil hydrochloride
  • Change to side-effects
  • Change to drug interactions, Addition of manufacturer, Addition of information on reporting a side effect.
Active Ingredients: Measles, mumps and rubella vaccine (live)
  • Change to date of revision
  • Change to marketing authorisation holder
Active Ingredients: Nitrazepam
  • 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 4.9 - 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: Moxifloxacin hydrochloride
  • Change to section 5.1 - Pharmacodynamic properties
Active Ingredients: Paracetamol, Codeine Phosphate Hemihydrate
  • Change to warnings or special precautions for use
  • Change to side-effects, Addition of information on reporting a side effect.
Active Ingredients: Dimethyl fumarate
Company: Biogen Idec Ltd
  • New SPC for new product
Active Ingredients: Dimethyl fumarate
Company: Biogen Idec Ltd
  • New SPC for new product
  • Change to drug interactions
Active Ingredients: Abacavir Sulfate
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
Active Ingredients: Abacavir Sulfate
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text