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Document information 02/05/2016 09:13
Current documents
SPC 2551
PIL 2100
Total: 4651
Submissions in the last 3 months
Updated: 772
New: 68

 

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
29 April 2016
New 9, Updated 22, Retired 2, [Total 33]
PIL retired AVONEX 30 micrograms powder and solvent for solution for injection
Active Ingredients: Interferon beta-1a
Company: Biogen Idec Ltd
  • PIL product / presentation discontinued
SPC retired AVONEX 30 micrograms powder and solvent for solution for injection
Active Ingredients: Interferon beta-1a
Company: Biogen Idec Ltd
  • SPC Product / presentation discontinued
Active Ingredients: ibandronic sodium monohydrate
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
Active Ingredients: ibandronic sodium monohydrate
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
Active Ingredients: Metformin Hydrochloride, pioglitazone hydrochloride
  • 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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • 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: Chlorhexidine digluconate
  • 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 - how to report a side effect
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
Active Ingredients: Emtricitabine, Tenofovir alafenamide fumarate
  • New PIL for new product
Active Ingredients: Emtricitabine, Tenofovir alafenamide fumarate
  • New PIL for new product
Active Ingredients: Salicylic Acid, Lactic Acid
  • Change to MA holder contact details
  • New PIL for medicines.ie
Active Ingredients: Crotamiton
  • Change due to harmonisation of SPC
Active Ingredients: Flucloxacillin Sodium
  • 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: ibandronic sodium monohydrate
  • Change to warnings or special precautions for use
  • Change to instructions about missed dose
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Change to dosage and administration, Addition of information on reporting a side effect.
Active Ingredients: Terbinafine hydrochloride
  • New PIL for medicines.ie
Active Ingredients: Terbinafine hydrochloride
  • New PIL for medicines.ie
Active Ingredients: Terbinafine hydrochloride
  • New PIL for medicines.ie
  • Change to section 6.1 - List of excipients
  • Change to section 6.1 - List of excipients
  • Change to section 6.1 - List of excipients
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to drug interactions
  • Change to MA holder contact details
  • Change to MA holder contact details
Active Ingredients: Triclosan, Benzalkonium Chloride, Light Liquid Paraffin
  • Change to MA holder contact details
  • Change to MA holder contact details
Active Ingredients: Xylometazoline Hydrochloride
  • New PIL for medicines.ie
Active Ingredients: Xylometazoline Hydrochloride
  • Change to MA holder contact details
Active Ingredients: Pantoprazole sodium sesquihydrate
  • New SPC for new product
Active Ingredients: Pantoprazole sodium sesquihydrate
  • New PIL for new product
Active Ingredients: Pneumococcal polysaccharide conjugate vaccine
  • Change to further information section
  • Change to date of revision
Active Ingredients: Gramicidin, Framycetin sulfate, Dexamethasone sodium metasulphobenzoate
  • Change to warnings or special precautions for use
  • Change to date of revision
  • Change to warnings or special precautions for use
  • Change to instructions about overdose
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to further information section
  • Change to date of revision
  • Change to improve clarity and readability
  • Change due to harmonisation of PIL
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
28 April 2016
New 0, Updated 16, Retired 0, [Total 16]
Active Ingredients: Metformin Hydrochloride, pioglitazone hydrochloride
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to instructions about overdose
  • Change to side-effects
  • Change to information about drinking alcohol
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Change to appearance of the medicine
  • 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 - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
Active Ingredients: Levonorgestrel
  • Change to date of revision
  • Change to dosage and administration
Active Ingredients: Levonorgestrel
  • Change to section 4.2 - Posology and method of administration
Active Ingredients: Esomeprazole magnesium trihydrate
  • 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 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
Active Ingredients: Esomeprazole magnesium trihydrate
  • 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 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
  • 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 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
27 April 2016
New 0, Updated 12, Retired 0, [Total 12]
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.3 - Shelf life
  • 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
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to warnings or special precautions for use
  • Change of contraindications
Active Ingredients: Chlorhexidine digluconate
  • Change of inactive ingredient
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
Active Ingredients: Gabapentin
  • Correction of spelling/typing errors
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
Active Ingredients: Esomeprazole magnesium trihydrate
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Change to storage instructions
  • Change to side-effects
  • Change to date of revision
  • Change to storage instructions
  • Change to side-effects
  • Change to date of revision
Active Ingredients: Romiplostim
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
Active Ingredients: Romiplostim
  • Change to date of revision
  • Change of special precautions for disposal
Active Ingredients: Collagenase clostridium histolyticum
  • Removal of black triangle
  • Change to section 10 - Date of revision of the text