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Document information 09/02/2010 00:51
Current documents
SPC 2167
PIL 1812
Total: 3979
Submissions in the last 3 months
Updated: 695
New: 93

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These are the latest new, updated and retired (removed) Summaries of Product Characteristics (SPCs) and Patient Information Leaflets (PILs) on medicines.ie. More help.

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Document Type:
PIL SPC
Status:  
New Update Retired
08 February 2010
New 0, Updated 13, Retired 5, [Total 18]
SPC updated Brufen 400 Tablets
Active Ingredients: Ibuprofen
Company: Abbott Laboratories Ireland Limited | Document History
  • Change to section 4.3 - Contraindications
  • 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
SPC updated Brufen Paediatric 100mg/5ml Oral Suspension
Active Ingredients: Ibuprofen
Company: Abbott Laboratories Ireland Limited | Document History
  • Change to section 4.3 - Contraindications
  • 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
PIL updated Casodex 50mg Tablets
Active Ingredients: Bicalutamide
Company: AstraZeneca Pharmaceuticals (Ireland) Ltd | Document History
  • Change to side-effects
PIL updated CONCERTA XL 18 mg and 36 mg prolonged-release tablets
Active Ingredients: Methylphenidate Hydrochloride
Company: Janssen-Cilag Ltd | Document History
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision
  • Change due to user-testing of patient information
PIL updated Concerta XL 27mg
Active Ingredients: Methylphenidate Hydrochloride
Company: Janssen-Cilag Ltd | Document History
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision
  • Change due to user-testing of patient information
SPC updated Frumil Low Strength 20mg/2.5mg Tablets
Active Ingredients: Amiloride Hydrochloride, Furosemide
Company: sanofi-aventis | Document History
  • 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
PIL retired Konverge 40 mg/10 mg film-coated tablets (A. Menarini Pharmaceuticals Ltd and Daiichi Sankyo Ireland Ltd)
Active Ingredients: olmesartan medoxomil, Amlodipine besilate
Company: A.Menarini Pharmaceuticals Ltd
  • Joint PIL superseded by PILs for individual presentations
PIL retired Konverge 40 mg/5 mg film-coated tablets (A.Menarini Pharmaceuticals Ltd and Daiichi Sankyo Ireland Ltd)
Active Ingredients: olmesartan medoxomil, Amlodipine besilate
Company: A.Menarini Pharmaceuticals Ltd
  • Joint PIL superseded by PILs for individual presentations
PIL retired PENTAVAC®
Active Ingredients: Haemophilus Influenzae Vaccine, Diphtheria, tetanus, pertussis (acellular) and poliomyelitis (inactivated)
Company: Sanofi Pasteur MSD Limited
SPC retired PENTAVAC®
Active Ingredients: Diphtheria Tetanus Pertussis (acellular) and Hib Vaccine
Company: Sanofi Pasteur MSD Limited
PIL updated Rapamune 1 mg coated tablets
Active Ingredients: Sirolimus
Company: Wyeth Pharmaceuticals | Document History
  • Change to side-effects
  • Change to MA holder contact details
PIL updated Rapamune 1 mg/ml oral solution
Active Ingredients: Sirolimus
Company: Wyeth Pharmaceuticals | Document History
  • Change to side-effects
  • Change to MA holder contact details
PIL updated Rapamune 2 mg coated tablets
Active Ingredients: Sirolimus
Company: Wyeth Pharmaceuticals | Document History
  • Change to side-effects
  • Change to MA holder contact details
SPC updated Sotacor Tablets
Active Ingredients: sotalol hydrochloride
Company: Bristol-Myers Squibb Pharmaceuticals Ltd | Document History
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 8 - MA number
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
SPC updated Stugeron 25 mg
Active Ingredients: Cinnarizine
Company: McNeil Healthcare (Ireland) Ltd | Document History
  • Change to section 5.1 - Pharmacodynamic properties
PIL updated TETRAVAC
Active Ingredients: Diphtheria, tetanus, pertussis (acellular) and poliomyelitis (inactivated) vaccine
Company: Sanofi Pasteur MSD Limited | Document History
  • Change to side-effects
  • Change to date of revision
SPC updated Tyverb 250 mg film-coated tablets
Active Ingredients: Lapatinib ditosylate monohydrate
Company: GlaxoSmithKline (Ireland) Ltd | Document History
  • Change to section 4.8 - Undesirable effects
SPC retired Valium Tablets
Active Ingredients: Diazepam
Company: Roche Products (Ireland) Ltd
  • Licence Withdrawn
06 February 2010
New 0, Updated 0, Retired 1, [Total 1]
SPC retired Velosef for Injection 500 mg & 1g
Active Ingredients: Cephradine
Company: Bristol-Myers Squibb Pharmaceuticals Ltd
  • SPC Product / presentation discontinued
05 February 2010
New 1, Updated 11, Retired 11, [Total 23]
SPC retired Brufen 600 Tablets
Active Ingredients: Ibuprofen
Company: Abbott Laboratories Ireland Limited
SPC updated Brufen 600 Tablets
Active Ingredients: Ibuprofen
Company: Abbott Laboratories Ireland Limited | Document History
  • Change to section 4.3 - Contraindications
  • 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
SPC updated CoAprovel 150 mg/12.5 mg, 300/12.5 mg and 300/25 mg film-coated tablets
Active Ingredients: Hydrochlorothiazide, Irbesartan
Company: Sanofi Pharma Bristol-Myers Squibb SNC | Document History
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
SPC retired CoAprovel 150 mg/12.5 mg, 300/12.5 mg and 300/25 mg film-coated tablets
Active Ingredients: Hydrochlorothiazide, Irbesartan
Company: Sanofi Pharma Bristol-Myers Squibb SNC
SPC retired E45 Cream
Active Ingredients: White Soft Paraffin, Light Liquid Paraffin, Anhydrous Lanolin
Company: Reckitt Benckiser Ireland Limited
SPC updated E45 Cream
Active Ingredients: White Soft Paraffin, Light Liquid Paraffin, Anhydrous Lanolin
Company: Reckitt Benckiser Ireland Limited | Document History
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
PIL updated Humulin M3 (Mixture 3), 100IU/ml suspension for injection in vial
Active Ingredients: Insulin human
Company: Eli Lilly and Company (Ireland) Limited | Document History
  • Change to date of revision
  • Change due to harmonisation of patient information leaflet
PIL retired Humulin M3 (Mixture 3), 100IU/ml suspension for injection in vial
Active Ingredients: Insulin human
Company: Eli Lilly and Company (Ireland) Limited
PIL retired Humulin S (soluble), 100IU/ml solution for injection in vial
Active Ingredients: Insulin human
Company: Eli Lilly and Company (Ireland) Limited
PIL updated Humulin S (soluble), 100IU/ml solution for injection in vial
Active Ingredients: Insulin human
Company: Eli Lilly and Company (Ireland) Limited | Document History
  • Change to date of revision
  • Change due to harmonisation of patient information leaflet
PIL retired Nalorex
Active Ingredients: Naltrexone Hydrochloride
Company: Bristol-Myers Squibb Pharmaceuticals Ltd
PIL updated Nalorex
Active Ingredients: Naltrexone Hydrochloride
Company: Bristol-Myers Squibb Pharmaceuticals Ltd | Document History
  • Change to packaging
  • Change to storage instructions
  • Change to date of revision
PIL updated Neulasta
Active Ingredients: Pegfilgrastim
Company: Amgen Ltd | Document History
  • Change to date of revision
PIL retired Neulasta
Active Ingredients: Pegfilgrastim
Company: Amgen Ltd
PIL updated Protelos
Active Ingredients: Strontium Ranelate
Company: Servier Laboratories Ireland Ltd | Document History
  • Change to side-effects
  • Change to date of revision
PIL retired Protelos
Active Ingredients: Strontium Ranelate
Company: Servier Laboratories Ireland Ltd
PIL retired Qlaira film-coated tablets
Active Ingredients: Estradiol valerate, dienogest
Company: Bayer Limited
PIL updated Qlaira film-coated tablets
Active Ingredients: Estradiol valerate, dienogest
Company: Bayer Limited | Document History
  • Change to further information section
  • Change to date of revision
PIL new Thalidomide
Active Ingredients: Thalidomide
Company: Celgene Ltd
  • New PIL for medicines.ie
PIL retired ZITHROMAX 250mg CAPSULES
Active Ingredients: Azithromycin dihydrate
Company: Pfizer Healthcare Ireland
PIL updated ZITHROMAX 250mg CAPSULES
Active Ingredients: Azithromycin dihydrate
Company: Pfizer Healthcare Ireland | Document History
  • Change due to user-testing of patient information
PIL updated ZITHROMAX Powder for Oral Suspension 200MG/5ML
Active Ingredients: Azithromycin dihydrate
Company: Pfizer Healthcare Ireland | Document History
  • Change due to user-testing of patient information
PIL retired ZITHROMAX Powder for Oral Suspension 200MG/5ML
Active Ingredients: Azithromycin dihydrate
Company: Pfizer Healthcare Ireland
04 February 2010
New 0, Updated 17, Retired 22, [Total 39]
SPC retired Apidra 100 U/ml , solution for injection in pre-filled pen. Optiset
Active Ingredients: Insulin Glulisine
Company: sanofi-aventis
SPC updated Apidra 100 U/ml , solution for injection in pre-filled pen. Optiset
Active Ingredients: Insulin Glulisine
Company: sanofi-aventis | Document History
  • Change to section 4.2 - Posology and method of administration
SPC updated Apidra 100 U/ml solution for injection in a pre-filled pen. Solostar
Active Ingredients: Insulin Glulisine
Company: sanofi-aventis | Document History
  • Change to section 4.2 - Posology and method of administration
SPC retired Apidra 100 U/ml solution for injection in a pre-filled pen. Solostar
Active Ingredients: Insulin Glulisine
Company: sanofi-aventis
SPC updated Apidra 100 U/ml, solution for injection in vial
Active Ingredients: Insulin glulisine
Company: sanofi-aventis | Document History
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
SPC retired Apidra 100 U/ml, solution for injection in vial
Active Ingredients: Insulin glulisine
Company: sanofi-aventis
PIL retired Augmentin Dispersible Tablets 375mg PIL
Active Ingredients: Amoxycillin, Clavulanic Acid
Company: GlaxoSmithKline (Ireland) Ltd
  • PIL product / presentation discontinued
PIL retired Augmentin Junior Suspension
Active Ingredients: Amoxicillin trihydrate, Potassium clavulanate
Company: GlaxoSmithKline (Ireland) Ltd
  • PIL product / presentation discontinued
SPC retired Azactam 1g and 2g Powder for Solution for Injection or Infusion
Active Ingredients: Aztreonam
Company: Bristol-Myers Squibb Pharmaceuticals Ltd
SPC updated Azactam 1g and 2g Powder for Solution for Injection or Infusion
Active Ingredients: Aztreonam
Company: Bristol-Myers Squibb Pharmaceuticals Ltd | Document History
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - MA number
PIL retired Bondronat 2mg/2ml concentrate for solution for infusion
Active Ingredients: ibandronic acid, monosodium salt, monohydrate
Company: Roche Products (Ireland) Ltd
PIL updated Bondronat 2mg/2ml concentrate for solution for infusion
Active Ingredients: ibandronic acid, monosodium salt, monohydrate
Company: Roche Products (Ireland) Ltd | Document History
  • Change to warnings or special precautions for use
PIL updated Bondronat 6mg/6ml concentrate for solution for infusion
Active Ingredients: ibandronic acid, monosodium salt, monohydrate
Company: Roche Products (Ireland) Ltd | Document History
  • Change to warnings or special precautions for use
PIL retired Bondronat 6mg/6ml concentrate for solution for infusion
Active Ingredients: ibandronic acid, monosodium salt, monohydrate
Company: Roche Products (Ireland) Ltd
PIL retired Cilest 250/35 microgram tablets
Active Ingredients: Ethinyloestradiol, Norgestimate
Company: Janssen-Cilag Ltd
  • Change to marketing authorisation holder address
PIL updated Cilest 250/35 microgram tablets
Active Ingredients: Ethinyloestradiol, Norgestimate
Company: Janssen-Cilag Ltd | Document History
  • Change to warnings or special precautions for use
  • Change to drug interactions
  • Change to date of revision
PIL retired HBVAXPRO 10mcg
Active Ingredients: Hepatitis B vaccine (rDNA)
Company: Sanofi Pasteur MSD Limited
PIL updated HBVAXPRO 10mcg
Active Ingredients: Hepatitis B vaccine (rDNA)
Company: Sanofi Pasteur MSD Limited | Document History
  • Change to date of revision
  • Change to MA holder contact details
PIL retired HBVAXPRO 40mcg
Active Ingredients: Hepatitis B vaccine (rDNA)
Company: Sanofi Pasteur MSD Limited
PIL updated HBVAXPRO 40mcg
Active Ingredients: Hepatitis B vaccine (rDNA)
Company: Sanofi Pasteur MSD Limited | Document History
  • Change to date of revision
  • Change to MA holder contact details
PIL retired HBVAXPRO 5mcg
Active Ingredients: Hepatitis B vaccine (rDNA)
Company: Sanofi Pasteur MSD Limited
PIL updated HBVAXPRO 5mcg
Active Ingredients: Hepatitis B vaccine (rDNA)
Company: Sanofi Pasteur MSD Limited | Document History
  • Change to date of revision
  • Change to MA holder contact details
SPC retired Herceptin 150mg Powder for concentrate for solution for infusion
Active Ingredients: Trastuzumab
Company: Roche Products (Ireland) Ltd
SPC updated Herceptin 150mg Powder for concentrate for solution for infusion
Active Ingredients: Trastuzumab
Company: Roche Products (Ireland) Ltd | Document History
  • Change to section 4.1 - Therapeutic indications
  • 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
PIL updated Insuman Comb 25 100 IU/ml OptiSet suspension for injection
Active Ingredients: Insulin human
Company: sanofi-aventis | Document History
  • Improved electronic presentation
PIL retired Insuman Comb 25 100 IU/ml OptiSet suspension for injection
Active Ingredients: Insulin human
Company: sanofi-aventis
PIL updated Insuman Comb 25 100IU/ml Suspension for Injection in a Vial
Active Ingredients: Insulin human
Company: sanofi-aventis | Document History
  • Improved electronic presentation
PIL retired Insuman Comb 25 100IU/ml Suspension for Injection in a Vial
Active Ingredients: Insulin human
Company: sanofi-aventis
SPC retired Intal 5 Inhaler
Active Ingredients: Sodium Cromoglycate
Company: sanofi-aventis
  • Licence Withdrawn
PIL retired KENALOG Injection 40 mg/ml
Active Ingredients: Triamcinolone Acetonide
Company: Bristol-Myers Squibb Pharmaceuticals Ltd
  • PIL product / presentation discontinued
SPC retired Kenalog Injection 40mg/ml
Active Ingredients: Triamcinolone Acetonide
Company: Bristol-Myers Squibb Pharmaceuticals Ltd
  • SPC Product / presentation discontinued
PIL updated Perfalgan 10 mg/ml Solution for Infusion
Active Ingredients: Paracetamol
Company: Bristol-Myers Squibb Pharmaceuticals Ltd | Document History
  • Change to side-effects
  • Change to drug interactions
PIL retired Perfalgan 10 mg/ml Solution for Infusion
Active Ingredients: Paracetamol
Company: Bristol-Myers Squibb Pharmaceuticals Ltd
SPC updated Tracleer 125mg
Active Ingredients: Bosentan monohydrate
Company: Actelion Pharmaceuticals UK Ltd | Document History
  • Change to section 4.8 - Undesirable effects
SPC retired Tracleer 125mg
Active Ingredients: Bosentan monohydrate
Company: Actelion Pharmaceuticals UK Ltd
SPC updated Tredaptive 1000 mg/20 mg modified release tablets
Active Ingredients: Nicotinic Acid, Laropiprant
Company: Merck Sharp & Dohme Ireland (Human Health) Limited | Document History
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
SPC retired Tredaptive 1000 mg/20 mg modified release tablets
Active Ingredients: Nicotinic Acid, Laropiprant
Company: Merck Sharp & Dohme Ireland (Human Health) Limited
SPC updated Xolair 150mg Powder and Solvent for Solution for Injection
Active Ingredients: Omalizumab
Company: Novartis Ireland Limited | Document History
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.2 - Pharmacokinetic properties
SPC retired Xolair 150mg Powder and Solvent for Solution for Injection
Active Ingredients: Omalizumab
Company: Novartis Ireland Limited