We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we'll assume that you are happy to receive all cookies on the medicines.ie website. Find out more

Document information 25/08/2016 21:06
Current documents
SPC 2547
PIL 2140
Total: 4687
Submissions in the last 3 months
Updated: 829
New: 91

 

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.

Filter Results

Document Type:
PIL SPC
Status:  
New Update Retired
25 August 2016
New 4, Updated 17, Retired 0, [Total 21]
Active Ingredients: Vernakalant Hydrochloride
  • New PIL for medicines.ie
Active Ingredients: Edoxaban tosilate
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
Active Ingredients: Edoxaban tosilate
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
Active Ingredients: Edoxaban tosilate
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
Active Ingredients: Ibuprofen, Pseudoephedrine Hydrochloride
  • New SPC for medicines.ie
Active Ingredients: Metformin Hydrochloride, Empagliflozin
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Active Ingredients: Rabbit Anti-Human Thymocyte Immunoglobulin
  • Change to date of revision
Active Ingredients: Iron Sucrose
  • Change to side-effects
  • 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
  • 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
  • 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: Ondansetron hydrochloride dihydrate
  • Change to section 4.9 - Overdose
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
Active Ingredients: Ondansetron hydrochloride dihydrate
  • Change to section 4.9 - Overdose
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
Active Ingredients: Ondansetron
  • 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: Ondansetron hydrochloride dihydrate
  • Change to section 4.9 - Overdose
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text
Active Ingredients: Ondansetron hydrochloride dihydrate
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
Active Ingredients: Ondansetron hydrochloride dihydrate
  • Change to section 4.9 - Overdose
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
Active Ingredients: Ondansetron
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
Active Ingredients: Ondansetron
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
24 August 2016
New 0, Updated 17, Retired 0, [Total 17]
Active Ingredients: Methyldopa
Company: Aspen | Document History
  • Change to further information section
  • Change to date of revision
  • Change to improve clarity and readability
Active Ingredients: Methyldopa
Company: Aspen | Document History
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
Active Ingredients: Methyldopa
Company: Aspen | Document History
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
Active Ingredients: Clindamycin Phosphate
  • Change to side-effects
  • Change to date of revision
Active Ingredients: Fulvestrant
  • 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 Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
Active Ingredients: Fulvestrant
  • Change to side-effects
  • Change to further information section
  • Change to date of revision
Active Ingredients: Ritonavir, Lopinavir
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision
Active Ingredients: Ritonavir, Lopinavir
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision
Active Ingredients: Ritonavir, Lopinavir
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision
Active Ingredients: Trametinib dimethyl sulfoxide
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
Active Ingredients: Simeprevir sodium
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Active Ingredients: Fosphenytoin Sodium
  • Change to warnings or special precautions for use
  • Change to information about drinking alcohol
  • Change to further information section
  • Change to date of revision
Active Ingredients: Aliskiren hemifumarate
  • Change to date of revision
  • Change to dosage and administration, Addition of joint PIL covering all presentations, Addition of information on reporting a side effect.
Active Ingredients: Lenalidomide
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text
Active Ingredients: Lenalidomide
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text
Active Ingredients: Ritonavir, Ombitasvir, Paritaprevir
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to side-effects
  • Change to date of revision
  • Change to dosage and administration
23 August 2016
New 0, Updated 8, Retired 1, [Total 9]
Active Ingredients: Simethicone, Loperamide Hydrochloride
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
Active Ingredients: Nintedanib esilate
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Active Ingredients: Simeprevir sodium
  • Change to warnings or special precautions for use
  • Change to date of revision
PIL retired Rasilez 300mg film-coated tablets
Active Ingredients: Aliskiren hemifumarate
  • Individual presentations superseded by joint PIL
Active Ingredients: Lenalidomide
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text
Active Ingredients: Lenalidomide
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text