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Document information 30/09/2016 14:24
Current documents
SPC 2605
PIL 2140
Total: 4745
Submissions in the last 3 months
Updated: 822
New: 147

 

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
30 September 2016
New 1, Updated 15, Retired 0, [Total 16]
  • Change to date of revision
  • Change to marketing authorisation holder
  • 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
  • New SPC for new product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • 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 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Active Ingredients: verapamil hydrochloride
  • Change to date of revision
Active Ingredients: Pantoprazole sodium sesquihydrate
  • Change to date of revision
  • Change to marketing authorisation holder
Active Ingredients: Pantoprazole sodium sesquihydrate
  • Change to date of revision
  • Change to marketing authorisation holder
Active Ingredients: Evolocumab
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text
Active Ingredients: Evolocumab
  • Change to storage instructions
  • Change to date of revision
Active Ingredients: Evolocumab
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text
Active Ingredients: Evolocumab
  • Change to storage instructions
  • Change to date of revision
Active Ingredients: Lenalidomide
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Active Ingredients: octreotide acetate
  • 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
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • 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
Active Ingredients: octreotide acetate
  • 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
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • 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
Active Ingredients: octreotide acetate
  • 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
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • 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 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
29 September 2016
New 0, Updated 9, Retired 5, [Total 14]
PIL retired Bisoprolol 5mg or 10mg film-coated tablets
Active Ingredients: Bisoprolol Fumarate
  • Licence Withdrawn
SPC retired Bisoprolol 5mg or 10mg film-coated tablets
Active Ingredients: Bisoprolol Fumarate
  • Licence Withdrawn
  • Change to side-effects
  • Change to date of revision
  • Change to marketing authorisation holder
  • Change to improve clarity and readability, Correction of spelling/typing errors
PIL retired Kogenate Bayer (Medimop) 1000 IU
Active Ingredients: Octocog Alfa
Company: Bayer Limited
  • Individual presentations superseded by joint PIL
PIL retired Kogenate Bayer (Medimop) 2000 IU
Active Ingredients: Octocog Alfa
Company: Bayer Limited
  • Individual presentations superseded by joint PIL
  • Change to warnings or special precautions for use
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Change to dosage and administration
  • Change due to harmonisation of PIL, Addition of joint PIL covering all presentations
PIL retired Kogenate Bayer (Medimop) 500 IU
Active Ingredients: Octocog Alfa
Company: Bayer Limited
  • Individual presentations superseded by joint PIL
Active Ingredients: Alfacalcidol
  • 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 10 - Date of revision of the text
  • Change to improve clarity and readability
Active Ingredients: Alfacalcidol
  • 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 10 - Date of revision of the text
  • Change to improve clarity and readability
Active Ingredients: Zidovudine
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text
Active Ingredients: Zidovudine
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text
Active Ingredients: Zidovudine
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text
Active Ingredients: Betahistine dihydrochloride
  • Change to further information section
  • Change to date of revision
  • Change of distributor details
  • Change to section 2 - Qualitative and quantitative composition
  • 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 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 6.1 - List of excipients
  • Change to section 9 - Date of renewal of authorisation
  • Change to improve clarity and readability
28 September 2016
New 2, Updated 12, Retired 0, [Total 14]
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
  • New PIL for new product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
Active Ingredients: Nintedanib esilate
  • 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
Active Ingredients: Pantoprazole sodium sesquihydrate
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
Active Ingredients: Zidovudine
  • Change to information about pregnancy or lactation
  • Change to date of revision
Active Ingredients: Zidovudine
  • Change to information about pregnancy or lactation
  • Change to date of revision
Active Ingredients: Zidovudine
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Change to section 2 - Qualitative and quantitative composition
  • 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 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 6.1 - List of excipients
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Active Ingredients: Lidocaine Hydrochloride, Amylmetacresol, 2, 4-Dichlorobenzyl alcohol
  • 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 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: Lidocaine, Amylmetacresol, 2, 4-Dichlorobenzyl alcohol
  • 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 - 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 warnings or special precautions for use
  • Change to information about driving or using machinery
  • Change to further information section
  • Change to date of revision, Removal of black triangle
  • New SPC for new product