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Document information 23/07/2017 20:28
Current documents
SPC 2626
PIL 2173
Total: 4799
Submissions in the last 3 months
Updated: 1064
New: 70

 

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
22 July 2017
New 0, Updated 2, Retired 0, [Total 2]
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
21 July 2017
New 3, Updated 32, Retired 6, [Total 41]
  • 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
Active Ingredients: Loperamide Hydrochloride
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.9 - Overdose
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 1 - Name of medicinal product
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • 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 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text, Correction of spelling/typing errors
  • Change to section 1 - what the product is used for
  • 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 6 - what the product contains
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
  • Change to other sources of information section, Correction of spelling/typing errors
Active Ingredients: Miconazole
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision
Active Ingredients: Fluticasone Propionate, Azelastine Hydrochloride
  • 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: Valproic Acid, Sodium Valproate
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text
Active Ingredients: Valproic Acid, Sodium Valproate
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text
Active Ingredients: Valproic Acid, Sodium Valproate
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text
Active Ingredients: Valproic Acid, Sodium Valproate
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text
Active Ingredients: Valproic Acid, Sodium Valproate
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text
Active Ingredients: Valproic Acid, Sodium Valproate
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text
Active Ingredients: Human papillomavirus 9-valent vaccine
  • New PIL for medicines.ie
Active Ingredients: Loperamide Hydrochloride
  • Change to section 4.4 - Special warnings and precautions for use
  • 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: Brodalumab
Company: LEO Pharma
  • New PIL for new product
Active Ingredients: Brodalumab
Company: LEO Pharma
  • New SPC for new product
SPC retired Kytril 1 mg Film-coated Tablets
Active Ingredients: Granisetron hydrochloride
  • Transfer of marketing authorisation holder
PIL retired Kytril 1 mg/1 ml & 3 mg/3 ml Solution for injection
Active Ingredients: Granisetron hydrochloride
  • Transfer of Marketing Authorisation licence
SPC retired Kytril 1 mg/1 ml solution for injection
Active Ingredients: Granisetron hydrochloride
  • Transfer of marketing authorisation holder
PIL retired Kytril 1mg and 2mg Film-coated Tablets
Active Ingredients: Granisetron hydrochloride
  • Transfer of Marketing Authorisation licence
SPC retired Kytril 2 mg Film-coated Tablets
Active Ingredients: Granisetron hydrochloride
  • Transfer of marketing authorisation holder
SPC retired Kytril 3 mg/3 ml solution for injection
Active Ingredients: Granisetron hydrochloride
  • Transfer of marketing authorisation holder
Active Ingredients: Pramipexole dihydrochloride monohydrate
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Change to other sources of information section
  • 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
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.9 - Overdose
  • 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 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
  • 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
  • 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
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
  • 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 4.8 - 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 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 4.8 - 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 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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
Active Ingredients: Methylphenidate Hydrochloride
  • Change to section 4 - possible side effects
Active Ingredients: Methylphenidate Hydrochloride
  • Change to section 4 - possible side effects
  • Change to section 2 - what you need to know - warnings and precautions
Active Ingredients: Nilotinib hydrochloride monohydrate
  • Change to section 1 - what the product is used for
  • Change to section 3 - duration of treatment
  • Change to section 4 - possible side effects
Active Ingredients: Nilotinib hydrochloride monohydrate
  • Change to section 1 - what the product is used for
  • Change to section 3 - duration of treatment
  • Change to section 4 - possible side effects
Active Ingredients: Pumpkin seed oil, Pumpkin seed, Saw palmetto fruit dry extract
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision
  • Change to section 4.8 - Undesirable effects
  • Change to section 7 - Marketing authorisation holder
20 July 2017
New 1, Updated 34, Retired 2, [Total 37]
Active Ingredients: Vilanterol trifenatate, Umeclidinium bromide
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Active Ingredients: Vilanterol trifenatate, Umeclidinium bromide
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
SPC retired Cardura 1mg Tablets
Active Ingredients: Cabergoline
  • SPC submitted in error
Active Ingredients: Desferrioxamine Mesylate
  • Change to section 5 - how to store or dispose
  • Change to section 4.8 - Undesirable effects
  • 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
SPC retired Epanutin Ready Mixed Parenteral 250 mg/5 ml Solution for Injection or Infusion
Active Ingredients: Phenytoin Sodium
  • SPC submitted in error
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
Active Ingredients: Diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus type b (Hib) conjugate vaccine (adsorbed).
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text
Active Ingredients: Metformin Hydrochloride, Saxagliptin hydrochloride
  • Correction of spelling/typing errors
Active Ingredients: Chlordiazepoxide hydrochloride
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 10 - Date of revision of the text
Active Ingredients: Ritonavir
  • Change to section 4.6 - Pregnancy and lactation
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Change to section 10 - Date of revision of the text
Active Ingredients: Ingenol mebutate
  • 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 5.2 - Pharmacokinetic properties
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text, Correction of spelling/typing errors, Removal of black triangle
Active Ingredients: Ingenol mebutate
  • 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 5.2 - Pharmacokinetic properties
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text, Correction of spelling/typing errors, Removal of black triangle
Active Ingredients: Potassium Chloride, Sodium Chloride, Sodium Gluconate, Sodium acetate, trihydrate, Magnesium chloride, hexahydrate
  • New SPC for medicines.ie
  • 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 4.8 - 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 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 4.8 - 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 1 - what the product is
  • Change to section 1 - what the product is used for
  • Change to section 3 - dose and frequency
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to MA holder contact details
  • 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 4.8 – 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 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 4.8 - 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 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • 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 2 - interactions with other medicines, food or drink
  • 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 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
Active Ingredients: Amisulpride
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Active Ingredients: Amisulpride
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Active Ingredients: Amisulpride
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Active Ingredients: Amisulpride
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Active Ingredients: Erythromycin, Zinc acetate
  • Change to section 7 - Marketing authorisation holder
  • Change to section 4 - possible side effects
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision