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Document information 28/02/2017 09:50
Current documents
SPC 2610
PIL 2158
Total: 4768
Submissions in the last 3 months
Updated: 844
New: 87

 

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
28 February 2017
New 0, Updated 7, Retired 0, [Total 7]
  • 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: Brivaracetam
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text
Active Ingredients: Testosterone
  • Change to section 10 - Date of revision of the text
Active Ingredients: Testosterone
  • Change to section 6 - date of revision
Active Ingredients: bortezomib mannitol boronic ester
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals
27 February 2017
New 0, Updated 18, Retired 5, [Total 23]
  • 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 10 - Date of revision of the text
Active Ingredients: Botulinum Toxin Type A
  • Change to section 3 - duration of treatment
  • Change to section 6 - date of revision
  • 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
Active Ingredients: Brivaracetam
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision
  • Change to section 4.2 - Posology and method of administration
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
  • Change to section 4.2 - Posology and method of administration
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
Active Ingredients: Dasabuvir sodium monohydrate
  • Change to section 3 - dose and frequency
  • Change to section 6 - date of revision
SPC retired Fluorets
Active Ingredients: Fluorescein Sodium
  • Licence Withdrawn
PIL retired Fluorets
Active Ingredients: Fluorescein Sodium
  • Licence withdrawn
Active Ingredients: Carbomer
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Active Ingredients: Carbomer
  • Change to section 2 - excipient warnings
  • Change to section 3 - use in children/adolescents
  • Change to section 6 - date of revision
SPC retired Minims Cyclopentolate 0.5% w/v, Eye drops solution
Active Ingredients: Cyclopentolate Hydrochloride
  • Licence Withdrawn
PIL retired Minims Cyclopentolate Hydrochloride 0.5 % and 1 % w/v
Active Ingredients: Cyclopentolate Hydrochloride
  • Licence withdrawn
Active Ingredients: Nicotine resinate
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 4.7 - 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 5.2 - Pharmacokinetic properties
  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
Active Ingredients: Nicotine resinate
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 4.7 - 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 5.2 - Pharmacokinetic properties
  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
Active Ingredients: Simeprevir sodium
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision
Active Ingredients: Ascorbic Acid (Vitamin C), Riboflavine (Vitamin B2), Thiamine Hydrochloride (Vitamin B1), Pyridoxine Hydrochloride (Vitamin B6), Anhydrous glucose, nicotinamide (B3)
  • 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 2 - interactions with other medicines, food or drink
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision
SPC retired Revolade 25mg powder for oral suspension
Active Ingredients: Eltrombopag olamine
  • Presentation currently not marketed.
Active Ingredients: Eltrombopag olamine
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
Active Ingredients: Regorafenib
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
Active Ingredients: Ritonavir, Ombitasvir, Paritaprevir
  • Change to section 3 - dose and frequency
  • Change to section 6 - date of revision
24 February 2017
New 1, Updated 11, Retired 2, [Total 14]
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
Active Ingredients: ziprasidone hydrochloride monohydrate
  • Change to section 4.8 - Undesirable effects
Active Ingredients: ziprasidone hydrochloride monohydrate
  • Change to section 4.8 - Undesirable effects
Active Ingredients: ziprasidone hydrochloride monohydrate
  • Change to section 4.8 - Undesirable effects
Active Ingredients: ziprasidone hydrochloride monohydrate
  • Change to section 4.8 - Undesirable effects
  • New PIL for medicines.ie
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
PIL retired Repatha PFS
Active Ingredients: Evolocumab
Company: Amgen Ltd
  • Product/Presentation not currently marketed
SPC retired Repatha PFS
Active Ingredients: Evolocumab
Company: Amgen Ltd
  • Individual SPC superseded by joint SPC
Active Ingredients: Evolocumab
  • Change to section 6 - date of revision
Active Ingredients: Evolocumab
  • Change to section 10 - Date of revision of the text
  • Change from individual to joint SPC
Active Ingredients: Regorafenib
  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision
Active Ingredients: Goserelin Acetate
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text