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Document information 24/01/2017 17:10
Current documents
SPC 2613
PIL 2156
Total: 4769
Submissions in the last 3 months
Updated: 928
New: 85

 

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
24 January 2017
New 1, Updated 26, Retired 0, [Total 27]
  • 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 - possible side effects
  • Change to section 6 - date of revision
Active Ingredients: Pemetrexed disodium
  • 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 10 - Date of revision of the text
Active Ingredients: Insulin glulisine
  • Change to section 6 - marketing authorisation holder
Active Ingredients: Budesonide, Formoterol fumarate dihydrate
  • Change to section 4 - possible side effects
Active Ingredients: Budesonide, Formoterol fumarate dihydrate
  • Change to section 4 - possible side effects
Active Ingredients: Emtricitabine, Tenofovir alafenamide fumarate
  • 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: Emtricitabine, Tenofovir alafenamide fumarate
  • 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: Valsartan
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 1 - what the product is used for
  • 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 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - duration of treatment
  • 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 6 - date of revision
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 10 - Date of revision of the text
Active Ingredients: Rufinamide
  • 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 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 6 - date of revision, Correction of spelling/typing errors
Active Ingredients: Rufinamide
  • 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 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision, Correction of spelling/typing errors
  • Change to section 6 - manufacturer
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation holder
Active Ingredients: Ruxolitinib Phosphate
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
Active Ingredients: Methotrexate Sodium
Company: Hospira UK Ltd
  • New SPC for medicines.ie
Active Ingredients: Emtricitabine, Rilpivirine Hydrochloride, Tenofovir alafenamide fumarate
  • 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 to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
Active Ingredients: peginterferon beta-1a
  • Change to section 4 - possible side effects
Active Ingredients: Vancomycin Hydrochloride
  • Change to section 6.5 - Nature and contents of container
23 January 2017
New 1, Updated 9, Retired 0, [Total 10]
  • Change to section 6 - marketing authorisation holder
Active Ingredients: Insulin Glulisine
  • Change to section 6 - marketing authorisation holder
Active Ingredients: Estradiol Hemihydrate
  • 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 2 - driving and using machines
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision
Active Ingredients: Estradiol Hemihydrate
  • 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 4.7 - Effects on ability to drive and use machines
  • 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: Estradiol Hemihydrate
  • 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 2 - driving and using machines
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision
Active Ingredients: Estradiol Hemihydrate
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Active Ingredients: Metformin Hydrochloride, pioglitazone hydrochloride
  • Change to section 6 - manufacturer
Active Ingredients: Diphtheria, tetanus, pertussis (acellular) and poliomyelitis (inactivated) vaccine
  • 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
Active Ingredients: Methotrexate disodium
Company: Hospira UK Ltd
  • New SPC for medicines.ie
Active Ingredients: Ketoprofen
  • 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
20 January 2017
New 1, Updated 10, Retired 2, [Total 13]
Active Ingredients: Pemetrexed disodium
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
Active Ingredients: Hydrochlorothiazide, Candesartan Cilexetil
  • Change to section 6 - what the product looks like and pack contents
  • Change to name of medicinal product
Active Ingredients: Diphtheria, Tetanus and Pertussis vaccine
  • 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 4.6 - Pregnancy and lactation
  • 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: Doxorubicin hydrochloride
  • Correction of spelling/typing errors
Active Ingredients: Phenytoin
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Active Ingredients: Palbociclib
  • New SPC for new product
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text
Active Ingredients: Levonorgestrel
  • Correction of spelling/typing errors
Active Ingredients: Asfotase alfa
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • 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 section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
SPC retired SYLVANT 100 mg powder for concentrate for solution for infusion
Active Ingredients: Siltuximab
  • Joint SPC superseded by individual SPCs
SPC retired SYLVANT 400 mg powder for concentrate for solution for infusion
Active Ingredients: Siltuximab
  • Joint SPC superseded by individual SPCs
  • 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