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Document information 31/08/2014 03:13
Current documents
SPC 2388
PIL 1987
Total: 4375
Submissions in the last 3 months
Updated: 990
New: 57

 

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
29 August 2014
New 2, Updated 7, Retired 2, [Total 11]
PIL retired Cetrotide 3 mg
Active Ingredients: cetrorelix acetate
Company: Merck Serono
  • PIL product / presentation discontinued
SPC retired Cetrotide 3 mg
Active Ingredients: cetrorelix acetate
Company: Merck Serono
  • SPC Product / presentation discontinued
Active Ingredients: Empagliflozin
  • New SPC for new product
Active Ingredients: Empagliflozin
  • New SPC for new product
Active Ingredients: Oxybutynin Hydrochloride
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to date of revision
Active Ingredients: Meningococcal Group A, C, W135 and Y conjugate vaccine
  • Change to date of revision, Correction of spelling/typing errors
Active Ingredients: Ivabradine hydrochloride
  • Change to side-effects
  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
  • 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 4.5 - 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 - how to report a side effect
  • 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 10 - Date of revision of the text
Active Ingredients: Cobicistat
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Active Ingredients: Idarubicin Hydrochloride
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
28 August 2014
New 0, Updated 27, Retired 2, [Total 29]
Active Ingredients: Tenofovir disoproxil fumarate, Efavirenz, Emtricitabine
  • Change to warnings or special precautions for use
  • Improved electronic presentation
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.3 - Contraindications
  • 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 section 10 - Date of revision of the text
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.3 - Contraindications
  • 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 section 10 - Date of revision of the text
  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to date of revision
  • Change to improve clarity and readability
  • Change to warnings or special precautions for use
  • Change to instructions about missed dose
  • Change to side-effects
  • Change to date of revision
  • Change to improve clarity and readability, Addition of marketing authorisation holder
Active Ingredients: Tenofovir disoproxil fumarate, Emtricitabine, Rilpivirine Hydrochloride
  • Change to warnings or special precautions for use
  • Change to date of revision
  • Change of manufacturer
  • Change to date of revision
Active Ingredients: Aluminium Hydroxide, Magnesium Hydroxide
  • 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 4.9 - Overdose
Active Ingredients: Magnesium Hydroxide, Aluminium oxide, hydrated
  • 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 4.9 - Overdose
Active Ingredients: Simethicone, Magnesium Hydroxide, Aluminium oxide, hydrated
  • 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
Active Ingredients: Aluminium Hydroxide, Simethicone, Magnesium Hydroxide
  • 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
Active Ingredients: Potassium Hydroxyquinoline Sulphate, Benzoyl Peroxide, hydrous
  • 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 appearance of the medicine, Addition of information on reporting a side effect.
Active Ingredients: Tenofovir disoproxil fumarate, Emtricitabine, Elvitegravir, Cobicistat
  • Change to warnings or special precautions for use
  • Change to date of revision
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Change to storage instructions
  • Change to date of revision, Addition of information on reporting a side effect.
  • Change to storage instructions
  • Change to date of revision, Addition of information on reporting a side effect.
SPC retired TETRAVAC
Active Ingredients: Poliomyelitis Vaccine, Diphtheria, Tetanus and Pertussis vaccine
  • Presentation currently not marketed.
PIL retired TETRAVAC
Active Ingredients: Diphtheria, tetanus, pertussis (acellular) and poliomyelitis (inactivated) vaccine
  • Presentation currently not marketed.
Active Ingredients: Tenofovir disoproxil fumarate, Emtricitabine
  • Change to warnings or special precautions for use
  • Change to date of revision
  • Change to side-effects
  • Change to date of revision
  • Change to side-effects
  • Change to date of revision
  • Change to side-effects
  • Change to date of revision
  • Change to side-effects
  • Change to date of revision
Active Ingredients: sildenafil citrate
  • Change of licence holder
  • Change to side-effects
  • Change to date of revision
  • Change to MA holder contact details
Active Ingredients: Tenofovir disoproxil fumarate
  • Change to warnings or special precautions for use
  • Change to date of revision
  • Change to side-effects
  • Change to date of revision
  • 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 section 4.4 - Special warnings and precautions for use
27 August 2014
New 1, Updated 12, Retired 0, [Total 13]
Active Ingredients: Ibuprofen, Pseudoephedrine Hydrochloride
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to section 10 - Date of revision of the text
  • Change to section 1 - Name of medicinal product
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
Active Ingredients: Telaprevir
  • 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 10 - Date of revision of the text
Active Ingredients: Simvastatin, ezetimibe
  • 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 10 - Date of revision of the text
Active Ingredients: Meningococcal group C conjugate vaccine
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • 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: Pantoprazole sodium sesquihydrate
  • 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 4.8 - 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 6.4 - Special precautions for storage
Active Ingredients: Pantoprazole sodium sesquihydrate
  • 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 4.8 - 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 5.2 - Pharmacokinetic properties
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text
  • New PIL for new product
  • Change to side-effects
  • Change to date of revision
Active Ingredients: valganciclovir hydrochloride
  • Change to paediatric information
  • 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 4.8 - 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 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
Active Ingredients: valganciclovir hydrochloride
  • Change to paediatric information
  • 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 4.8 - 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 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
Active Ingredients: Simvastatin
  • 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 10 - Date of revision of the text