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Document information 17/01/2018 11:22
Current documents
SPC 2625
PIL 2179
Total: 4804
Submissions in the last 3 months
Updated: 882
New: 67

 

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
17 January 2018
New 0, Updated 5, Retired 0, [Total 5]
Active Ingredients: fingolimod hydrochloride
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text
Active Ingredients: Meningococcal group B vaccine (recombinant, adsorbed)
  • 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
Active Ingredients: Varicella-zoster virus (live)
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
16 January 2018
New 2, Updated 15, Retired 2, [Total 19]
Active Ingredients: Amoxicillin trihydrate
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
Active Ingredients: Amoxicillin trihydrate
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
Active Ingredients: Amoxicillin sodium
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals
  • 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
PIL retired Enbrel 50mg solution for injection in pre-filled syringe
Active Ingredients: Etanercept
  • Individual PIL superseded by joint PIL
Active Ingredients: Entecavir
  • New SPC for new product
Active Ingredients: Entecavir monohydrate
  • New PIL for new product
Active Ingredients: Loratadine
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Active Ingredients: Chlorambucil
Company: Aspen | Document History
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text, Improved presentation of SPC
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision
Active Ingredients: Levofloxacin hemihydrate
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
SPC retired Tasigna 200mg Capsules
Active Ingredients: Nilotinib hydrochloride monohydrate
  • Individual SPC superseded by joint SPC
Active Ingredients: Meningococcal group B vaccine (recombinant, adsorbed)
  • Change to section 6 - date of revision
Active Ingredients: Estradiol Hemihydrate, Nomegestrol Acetate
  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision
15 January 2018
New 1, Updated 21, Retired 1, [Total 23]
Active Ingredients: Loperamide Hydrochloride
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text
Active Ingredients: Loperamide Hydrochloride
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision
Active Ingredients: Mycophenolate Mofetil
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision
Active Ingredients: Mycophenolate Mofetil
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision
SPC retired Diflucan Solution for Infusion 2mg/ml (50mg/25ml and 200mg/100ml)
Active Ingredients: Fluconazole
  • SPC submitted in error
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision
Active Ingredients: Terazosin monohydrochloride dihydrate
  • 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 4.6 - 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 10 - Date of revision of the text
Active Ingredients: Terazosin monohydrochloride dihydrate
  • 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 4.7 - 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 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
Active Ingredients: Terazosin monohydrochloride dihydrate
  • 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 4.6 - 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 10 - Date of revision of the text
Active Ingredients: Gabapentin
  • Change to section 1 - what the product is used for
  • Change to section 6 - what the product looks like and pack contents
  • New PIL for new product
Active Ingredients: Tapentadol hydrochloride
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Active Ingredients: Mesalazine
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Active Ingredients: Trimetazidine dihydrochloride
  • Change to section 2 - what you need to know - contraindications
  • Change to section 6 - what the product looks like and pack contents
Active Ingredients: Trimetazidine dihydrochloride
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
Active Ingredients: Tofacitinib citrate
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.2 - Pharmacokinetic properties