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Document information 25/04/2014 04:57
Current documents
SPC 2382
PIL 1983
Total: 4365
Submissions in the last 3 months
Updated: 928
New: 56

 

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
24 April 2014
New 3, Updated 14, Retired 1, [Total 18]
Active Ingredients: Bivalirudin
  • Change to MA holder contact details
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • 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.
  • Change to marketing authorisation holder
  • New PIL for medicines.ie
Active Ingredients: Terbinafine hydrochloride
  • Change to date of revision
  • Change due to user-testing of patient information
  • Change to date of revision
  • Change to dosage and administration
Active Ingredients: Tamsulosin Hydrochloride
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to improve clarity and readability
Active Ingredients: Follitropin alpha, Lutropin alfa
  • Change to section 4.2 - Posology and method of administration
  • 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: sildenafil citrate
  • Change to side-effects
  • Change to date of revision
  • Change to MA holder contact details
Active Ingredients: Omalizumab
  • New individual PIL (was previously included in a combined PIL)
PIL retired Xolair 75mg and 150mg solution for injection
Active Ingredients: Omalizumab
  • Joint PIL superseded by PILs for individual presentations
Active Ingredients: Omalizumab
  • New individual PIL (was previously included in a combined PIL)
Active Ingredients: Tramadol Hydrochloride
  • 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: Tramadol Hydrochloride
  • 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: Tramadol Hydrochloride
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 9 - Date of renewal of authorisation
Active Ingredients: Tramadol Hydrochloride
  • 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: Tramadol Hydrochloride
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
23 April 2014
New 0, Updated 21, Retired 0, [Total 21]
Active Ingredients: Clindamycin Phosphate
  • Change of manufacturer
  • Change to date of revision
  • Change to warnings or special precautions for use
Active Ingredients: Formoterol fumarate dihydrate
  • Change to warnings or special precautions for use
  • Change to side-effects
  • 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 10 - Date of revision of the text
Active Ingredients: Imatinib mesilate
  • Change to warnings or special precautions for use
Active Ingredients: Imatinib mesilate
  • Change to warnings or special precautions for use
Active Ingredients: Saquinavir mesilate
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text
Active Ingredients: verapamil hydrochloride
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
Active Ingredients: verapamil hydrochloride
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
Active Ingredients: verapamil hydrochloride
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
Active Ingredients: Sodium Cromoglicate
  • Change to information about driving or using machinery
Active Ingredients: Sodium Cromoglicate
  • Change to information about driving or using machinery
  • Change to warnings or special precautions for use
Active Ingredients: Octreotide
  • Change to packaging
  • Change to, or new use for medicine
Active Ingredients: Paracetamol, Codeine Phosphate Hemihydrate
  • 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
Active Ingredients: Paracetamol, Codeine Phosphate Hemihydrate
  • 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
Active Ingredients: Lanreotide acetate
  • Change to side-effects
Active Ingredients: Nilotinib hydrochloride monohydrate
  • Change to warnings or special precautions for use
  • Improved electronic presentation
22 April 2014
New 1, Updated 23, Retired 1, [Total 25]
Active Ingredients: Clomipramine hydrochloride
  • Change to warnings or special precautions for use
  • Change to side-effects, Addition of information on reporting a side effect.
Active Ingredients: Tipranavir
  • Change to warnings or special precautions for use
  • Change to side-effects, Addition of information on reporting a side effect.
Active Ingredients: Clozapine
  • Change to warnings or special precautions for use
Active Ingredients: Clozapine
  • Change to warnings or special precautions for use
  • Change to section 7 - Marketing authorisation holder
Active Ingredients: No Active Ingredients
  • Change to MA holder contact details
  • Change to section 7 - Marketing authorisation holder
Active Ingredients: No Active Ingredients
  • Change to MA holder contact details
Active Ingredients: Salicylic Acid, Betamethasone dipropionate
  • Change to MA holder contact details
Active Ingredients: Salicylic Acid, Betamethasone dipropionate
  • Change to section 7 - Marketing authorisation holder
Active Ingredients: Clostridium botulinum type A toxin-haemagglutinin complex
  • Addition of information on reporting a side effect.
Active Ingredients: Mometasone Furoate
  • Change to section 7 - Marketing authorisation holder
Active Ingredients: Mometasone Furoate
  • Change to MA holder contact details
Active Ingredients: Mometasone Furoate
  • Change to section 7 - Marketing authorisation holder
Active Ingredients: Mometasone Furoate
  • Change to MA holder contact details
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Change due to user-testing of patient information
Active Ingredients: Digoxin
Company: Aspen | Document History
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
SPC retired Nexium Control 20 mg gastro-resistant tablets
Active Ingredients: Esomeprazole magnesium trihydrate
  • Presentation currently not marketed.
  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to storage instructions
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to how the medicine works
  • Change to further information section
  • Change to date of revision
Active Ingredients: Rubella Vaccine, Measles Vaccine, Mumps Vaccine, Varicella Vaccine
  • New PIL for new product
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 10 - Date of revision of the text
Active Ingredients: Tamsulosin Hydrochloride
  • Change to side-effects
  • Change to date of revision
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text