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Document information 05/08/2015 13:24
Current documents
SPC 2506
PIL 2035
Total: 4541
Submissions in the last 3 months
Updated: 1540
New: 107

 

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
05 August 2015
New 2, Updated 11, Retired 0, [Total 13]
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
Active Ingredients: Loperamide Hydrochloride
  • Addition of information on reporting a side effect.
Active Ingredients: Cyclopentolate Hydrochloride
  • Change to side-effects
  • Change to date of revision, Addition of information on reporting a side effect.
Active Ingredients: Cyclopentolate Hydrochloride
  • Change to side-effects
  • Change to date of revision, Addition of information on reporting a side effect.
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 4.5 - 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
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
  • New SPC for new product
  • 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 4.8 – 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 4.4 - 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 10 - Date of revision of the text
  • 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
  • Removal of black triangle
Active Ingredients: Teduglutide
  • Change to MA holder contact details
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
04 August 2015
New 3, Updated 35, Retired 1, [Total 39]
Active Ingredients: Quinapril hydrochloride
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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
Active Ingredients: Quinapril hydrochloride
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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
Active Ingredients: Quinapril hydrochloride
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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
Active Ingredients: Glimepiride
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
Active Ingredients: Glimepiride
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
Active Ingredients: Glimepiride
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
Active Ingredients: Glimepiride
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
Active Ingredients: Acetylsalicylic acid (Aspirin)
  • Change to date of revision
  • Change to dosage and administration, Addition of information on reporting a side effect.
Active Ingredients: Amoxicillin trihydrate, Potassium clavulanate
  • 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 4.6 - Pregnancy and lactation
  • 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 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Change to improve clarity and readability
Active Ingredients: Amoxicillin trihydrate, Potassium clavulanate
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to instructions about missed dose
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to date of revision, Addition of information on reporting a side effect.
Active Ingredients: clopidogrel 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
Active Ingredients: Aspirin
  • Change to drug interactions
Active Ingredients: Tacrolimus
Company: Chiesi Limited
  • New PIL for new product
Active Ingredients: Tacrolimus
Company: Chiesi Limited
  • New PIL for new product
Active Ingredients: Tacrolimus
Company: Chiesi Limited
  • New PIL for new product
Active Ingredients: Piroxicam
  • Change to side-effects
  • Change to date of revision
Active Ingredients: Ispaghula Husk
  • Change of trade or active ingredient name
  • Change of trade or active ingredient name
Active Ingredients: Sodium Alginate, Calcium Carbonate, Sodium Hydrogen Carbonate
  • Change to warnings or special precautions for use
PIL retired Gaviscon Strawberry Chewable Tablets
Active Ingredients: Sodium Alginate, Calcium Carbonate, Sodium Hydrogen Carbonate
  • PIL - Product no longer marketed in Ireland
Active Ingredients: Influenza vaccine (surface antigen, inactivated)
  • Change to further information section
  • Change to date of revision
  • Change to side-effects, Addition of information on reporting a side effect.
Active Ingredients: verapamil hydrochloride
  • Change to side-effects, Addition of information on reporting a side effect.
Active Ingredients: verapamil hydrochloride
  • Change to side-effects, Addition of information on reporting a side effect.
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to instructions about missed dose
  • 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
  • Change to dosage and administration
  • Changes to therapeutic indications
  • Change to product name, Addition of information on reporting a side effect.
  • Introduction of new pack/pack size
  • Change to warnings or special precautions for use
Active Ingredients: Paracetamol, Pseudoephedrine Hydrochloride
  • Change to further information section
Active Ingredients: Macitentan
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
Active Ingredients: Hexetidine
  • Change to side-effects
  • Change to date of revision
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to side-effects
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Active Ingredients: Ciclopirox Olamine USP
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text
Active Ingredients: Glyceryl Trinitrate
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
Active Ingredients: Diclofenac Sodium
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.6 - Special precautions for disposal and other handling
03 August 2015
New 2, Updated 13, Retired 2, [Total 17]
Active Ingredients: Quinapril hydrochloride
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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
Active Ingredients: Tenofovir disoproxil fumarate, Efavirenz, Emtricitabine
  • 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: Daclatasvir dihydrochloride
  • 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 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
  • Change to dosage and administration
  • Addition of information on reporting a side effect.
SPC retired INTANZA 9 microgram/strain
Active Ingredients: Influenza vaccine (split virion, inactivated)
  • Product no longer marketed in Ireland
PIL retired INTANZA 9 microgram/strain
Active Ingredients: Influenza vaccine (split virion, inactivated)
  • Presentation currently not marketed.
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
Active Ingredients: Oxybutynin Hydrochloride
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text
Active Ingredients: brimonidine tartrate
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text
Active Ingredients: brimonidine tartrate
  • Change to warnings or special precautions for use
Active Ingredients: Macitentan
  • Change to date of revision
  • Change to, or new use for medicine
  • Change to instructions about missed dose
  • Change to side-effects
  • Change to date of revision
  • Change to dosage and administration
  • Changes to therapeutic indications
Active Ingredients: Brinzolamide, brimonidine tartrate
  • Improved electronic presentation
Active Ingredients: Ciclopirox Olamine USP
  • Change to date of revision
  • Change to improve clarity and readability, Addition of information on reporting a side effect.
Active Ingredients: Timolol Maleate, Tafluprost
  • New PIL for new product
Active Ingredients: Timolol Maleate, Tafluprost
  • New SPC for new product