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Document information 30/06/2016 23:57
Current documents
SPC 2550
PIL 2128
Total: 4678
Submissions in the last 3 months
Updated: 872
New: 86

 

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 June 2016
New 2, Updated 6, Retired 0, [Total 8]
  • Change to, or new use for medicine
  • 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
  • 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
Active Ingredients: Teduglutide
  • Change to date of revision
  • Change to name of manufacturer
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.7 - 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 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to side-effects, Addition of information on reporting a side effect.
Active Ingredients: Sufentanil Citrate
Company: Grunenthal Ltd
  • New SPC for new product
Active Ingredients: Sufentanil Citrate
Company: Grunenthal Ltd
  • New PIL for new product
29 June 2016
New 1, Updated 14, Retired 0, [Total 15]
  • 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 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
Active Ingredients: Daclatasvir dihydrochloride
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.3 - Shelf life
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
Active Ingredients: Fusidic Acid, Betamethasone Valerate
  • New PIL for new product
Active Ingredients: Emtricitabine, Elvitegravir, Cobicistat, Tenofovir alafenamide fumarate
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to further information section
  • Change to date of revision
  • Change to dosage and administration
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to dosage and administration
Active Ingredients: Norethisterone
  • Change to storage instructions
  • Change to date of revision
Active Ingredients: Evolocumab
  • Change to further information section
  • Change to date of revision
Active Ingredients: Evolocumab
  • Change to further information section
  • Change to date of revision
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
Active Ingredients: Eltrombopag olamine
  • 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
Active Ingredients: Dabrafenib mesilate
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – 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 6.3 - Shelf life
  • Change to section 4.8 - Undesirable effects
28 June 2016
New 0, Updated 13, Retired 0, [Total 13]
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision
  • Change to dosage and administration
Active Ingredients: Daclatasvir dihydrochloride
  • Change of trade or active ingredient name
  • Change to date of revision, Introduction of new pack/pack size
  • Change to date of revision
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Active Ingredients: Emtricitabine, Elvitegravir, Cobicistat, Tenofovir alafenamide fumarate
  • Change to further information section
  • Change to date of revision
Active Ingredients: Imatinib mesilate
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to warnings or special precautions for use
Active Ingredients: Methylnaltrexone bromide
  • Change to section 10 - Date of revision of the text
Active Ingredients: Eculizumab
  • Change to section 10 - Date of revision of the text
Active Ingredients: Trimetazidine dihydrochloride
  • Removal of black triangle
Active Ingredients: Doxycycline hyclate
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 1 - Name of medicinal product
  • 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 4.6 - Pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • 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 10 - Date of revision of the text