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Document information 25/09/2017 19:48
Current documents
SPC 2637
PIL 2181
Total: 4818
Submissions in the last 3 months
Updated: 905
New: 91

 

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
25 September 2017
New 1, Updated 13, Retired 2, [Total 16]
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
Active Ingredients: Clonidine hydrochloride
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
  • New PIL for new product, New PIL for medicines.ie
SPC retired Enbrel 50 mg solution for injection in pre-filled pen
Active Ingredients: Etanercept
  • Individual SPC superseded by joint SPC
Active Ingredients: Dasabuvir sodium monohydrate
  • 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: Brodalumab
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text
Active Ingredients: Sodium Cromoglicate
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision
Active Ingredients: Denosumab
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.6 - Special precautions for disposal and other handling
Active Ingredients: Denosumab
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • 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: docetaxel trihydrate
  • 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 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)
Active Ingredients: Eflornithine hydrochloride monohydrate
  • Change to Section 1 - what the product is
  • 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 3 - dose and frequency
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision
PIL retired Vibativ
Active Ingredients: Telavancin hydrochloride
  • Transfer of Marketing Authorisation licence
22 September 2017
New 1, Updated 5, Retired 0, [Total 6]
Active Ingredients: Mirabegron
  • Change to section 6 - date of revision, Removal of black triangle
Active Ingredients: Mecasermin
  • 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
Active Ingredients: Meptazinol hydrochloride
  • Change to section 6 - date of revision
Active Ingredients: Meptazinol hydrochloride
  • Change to section 6 - date of revision
Active Ingredients: Telotristat ethyl
  • New PIL for new product
  • Change to section 2 - what you need to know - contraindications
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision
21 September 2017
New 0, Updated 19, Retired 0, [Total 19]
Active Ingredients: Benzoyl Peroxide, hydrous
  • 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 - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text
Active Ingredients: Prilocaine, Lidocaine
Company: Aspen | Document History
  • 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
Active Ingredients: Prilocaine, Lidocaine
Company: Aspen | Document History
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision
  • Change to section 1 - what the product is used for
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals
Active Ingredients: Mecasermin
  • Change to section 6 - date of revision
  • Change to other sources of information section
Active Ingredients: Bupivacaine Hydrochloride, Adrenaline tartrate
Company: Aspen | Document History
  • 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
Active Ingredients: Bupivacaine Hydrochloride, Adrenaline tartrate
Company: Aspen | Document History
  • 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
Active Ingredients: Bupivacaine hydrochloride anhydrous
Company: Aspen | Document History
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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
Active Ingredients: Bupivacaine hydrochloride anhydrous
Company: Aspen | Document History
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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
Active Ingredients: Mivacurium Chloride
Company: Aspen | Document History
  • Change to section 6 - date of revision
Active Ingredients: Sorafenib tosilate
  • Change to section 4 - how to report a side effect
  • 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
  • Change to section 10 - Date of revision of the text
Active Ingredients: Fluticasone furoate , Vilanterol trifenatate
  • 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
  • Change to section 10 - Date of revision of the text
Active Ingredients: Fluticasone furoate , Vilanterol trifenatate
  • 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
  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - dose and frequency
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • 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
Active Ingredients: Denosumab
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text, Correction of spelling/typing errors, Improved presentation of SPC
Active Ingredients: Denosumab
  • 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 3 - how to take/use
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision
Active Ingredients: Adrenaline tartrate, lidocaine hydrochloride anhydrous
Company: Aspen | Document History
  • 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