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 25/06/2017 05:14
Current documents
SPC 2621
PIL 2160
Total: 4781
Submissions in the last 3 months
Updated: 1048
New: 56

 

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
23 June 2017
New 1, Updated 18, Retired 1, [Total 20]
Active Ingredients: Camellia sinensis (green tea) leaf extract
  • Change of distributor details
PIL retired Cinryze 500 Units powder and solvent for solution for injection
Active Ingredients: C1 inhibitor (human)
  • Retired from medicines.ie
Active Ingredients: Sodium Dihydrogen Phosphate Dihydrate, Disodium Phosphate Dodecahydrate
  • Change to section 1 - Name of medicinal product
  • 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 from joint to individual SPCs
Active Ingredients: Corifollitropin Alfa
  • New individual SPC (was previously included in combined SPC)
  • Change to section 3 - how to take/use
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 3 - how to take/use
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 3 - how to take/use
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 3 - how to take/use
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 3 - how to take/use
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
Active Ingredients: Lidocaine Hydrochloride, Ceftriaxone sodium
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision
Active Ingredients: Mesalazine
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision
Active Ingredients: Ofloxacin
  • Change to section 2 - what you need to know - contraindications
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
Active Ingredients: Ofloxacin Hydrochloride
  • Change to section 2 - what you need to know - contraindications
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
Active Ingredients: Levofloxacin hemihydrate
  • Change to section 2 - what you need to know - contraindications
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
Active Ingredients: Levofloxacin hemihydrate
  • Change to section 2 - what you need to know - contraindications
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
Active Ingredients: Denosumab
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
Active Ingredients: Erythromycin, Zinc acetate
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision
22 June 2017
New 2, Updated 16, Retired 0, [Total 18]
Active Ingredients: Candesartan Cilexetil
  • 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 10 - Date of revision of the text
  • New SPC for new product
  • 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 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
Active Ingredients: Sodium Dihydrogen Phosphate Dihydrate, Disodium Phosphate Dodecahydrate
  • Change to name of medicinal product
  • Change to section 5 - how to store or dispose
  • Change to section 4.3 - Contraindications
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
Active Ingredients: Sofosbuvir, Ledipasvir
  • Change to section 4.8 - Undesirable effects
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Active Ingredients: Influenza vaccine (split virion, inactivated)
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 10 - Date of revision of the text
  • Change to section 6.3 - Shelf life
  • Change to section 4.1 - Therapeutic indications
  • 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 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 3 - use in children/adolescents
  • Change to section 6 - date of revision
Active Ingredients: Cetirizine Dihydrochloride
  • New SPC for medicines.ie
Active Ingredients: Camphor, Menthol, Cajuput Oil, Clove Oil
  • Change to section 7 - Marketing authorisation holder
Active Ingredients: Camphor, Cajuput Oil, Clove Oil, Levomenthol
  • Change to section 7 - Marketing authorisation holder
21 June 2017
New 1, Updated 10, Retired 0, [Total 11]
Active Ingredients: Amlodipine besilate
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 10 - Date of revision of the text
Active Ingredients: Estradiol Hemihydrate
  • Change to Section 1 - what the product is
Active Ingredients: Estradiol Hemihydrate
  • Change to Section 1 - what the product is
Active Ingredients: Sofosbuvir, Ledipasvir
  • Change to section 4 - possible side effects
Active Ingredients: Influenza vaccine (split virion, inactivated)
  • Change to section 6 - what the product contains
Active Ingredients: Amlodipine besilate
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 10 - Date of revision of the text
Active Ingredients: Amlodipine besilate
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 10 - Date of revision of the text
  • 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
Active Ingredients: Methylphenidate Hydrochloride
Company: Flynn Pharma Ltd
  • Addition of joint SPC covering all presentations
Active Ingredients: Dabigatran etexilate mesilate
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text
Active Ingredients: Cetirizine Dihydrochloride
  • Change to section 6 - marketing authorisation holder