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Document information 17/10/2017 19:44
Current documents
SPC 2642
PIL 2186
Total: 4828
Submissions in the last 3 months
Updated: 894
New: 83

 

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 October 2017
New 0, Updated 22, Retired 1, [Total 23]
Active Ingredients: Amoxicillin trihydrate
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
Active Ingredients: Amoxicillin sodium
  • Change to section 2 - excipient warnings
  • Change to section 3 - use in children/adolescents
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals
Active Ingredients: Darbepoetin alfa
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
Active Ingredients: Darbepoetin alfa
  • 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: Darbepoetin alfa
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
Active Ingredients: Darbepoetin alfa
  • Change to section 4 - possible side effects
  • Change to section 6 - 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 4.7 - 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text
  • Change from individual to joint SPC
SPC retired Elonva 150 micrograms solution for injection
Active Ingredients: Corifollitropin Alfa
  • Individual SPC superseded by joint SPC
Active Ingredients: Amoxicillin trihydrate, Potassium clavulanate
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision
Active Ingredients: Lactic Acid, Sodium Chloride, Sodium Hydrogen Carbonate, Calcium Chloride , Magnesium chloride
  • 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 4.4 - 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 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
  • Change to section 1 - what the product is used for
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - use in children/adolescents
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision
  • Change to section 4 - how to report a side effect
Active Ingredients: Rabeprazole Sodium
  • Change to section 6 - date of revision, Correction of spelling/typing errors
Active Ingredients: Rubella Vaccine, Measles Vaccine, Mumps Vaccine
  • 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: Rubella Vaccine, Measles Vaccine, Mumps Vaccine
  • 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
  • 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 1 - what the product is used for
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - excipient warnings
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product looks like and pack contents
  • 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: Naloxone Hydrochloride dihydrate, Buprenorphine hydrochloride
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 6.6 - Special precautions for disposal and other handling
Active Ingredients: Naloxone Hydrochloride dihydrate, Buprenorphine hydrochloride
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 6.6 - Special precautions for disposal and other handling
Active Ingredients: Buprenorphine hydrochloride
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
  • 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 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
16 October 2017
New 0, Updated 19, Retired 1, [Total 20]
Active Ingredients: Everolimus
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
Active Ingredients: Alectinib hydrochloride
  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision
  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - contraindications
  • Change to section 6 - date of revision, Correction of spelling/typing errors
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision, Individual PILs superseded by joint PIL
PIL retired Elonva 150 micrograms solution for injection
Active Ingredients: Corifollitropin Alfa
  • Individual PIL superseded by joint PIL
Active Ingredients: Sofosbuvir, Velpatasvir
  • Change to section 5.3 - Preclinical safety data
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Active Ingredients: Domperidone
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • Change to section 7 - Marketing authorisation holder
  • Change to section 6 - manufacturer
  • Change to section 7 - Marketing authorisation holder
  • Change to section 7 - Marketing authorisation holder
  • Change to section 6 - manufacturer
  • Change to section 6 - manufacturer
  • Change to section 7 - Marketing authorisation holder
  • Change to section 6 - manufacturer
  • Change to section 6 - manufacturer
  • Change to section 6 - manufacturer
  • 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
13 October 2017
New 0, Updated 9, Retired 1, [Total 10]
Active Ingredients: Hydroxocobalamin
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
Active Ingredients: Phenytoin Sodium
  • Change to section 4.8 - Undesirable effects
SPC retired Epanutin Ready Mixed Parenteral 250 mg/5 ml Solution for Injection or Infusion
Active Ingredients: Phenytoin Sodium
  • SPC submitted in error
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text, Improved presentation of SPC
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text, Improved presentation of SPC
Active Ingredients: Sodium Alginate, Calcium Carbonate, Sodium Hydrogen Carbonate
  • Change to section 6 - what the product looks like and pack contents
Active Ingredients: Cisatracurium Besilate
Company: Aspen | Document History
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 9 - Date of first authorisation/renewal of the authorisation