go to medicines.ie homepage
Font Size
Search for:  
select
  Advanced Search

Document information 02/09/2010 21:53
Current documents
SPC 2183
PIL 1858
Total: 4041
Submissions in the last 3 months
Updated: 874
New: 71

 

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.

Filter Results

Document Type:
PIL SPC
Status:  
New Update Retired
02 September 2010
New 0, Updated 12, Retired 0, [Total 12]
SPC updated Becotide 100 Evohaler
Active Ingredients: Beclometasone Dipropionate
Company: Allen & Hanburys | Document History
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
SPC updated Becotide 250 Evohaler
Active Ingredients: Beclometasone Dipropionate
Company: Allen & Hanburys | Document History
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
SPC updated Becotide 50 Evohaler
Active Ingredients: Beclometasone Dipropionate
Company: Allen & Hanburys | Document History
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
PIL updated GARDASIL
Active Ingredients: human papillomavirus vaccine
Company: Sanofi Pasteur MSD Limited | Document History
  • Change to, or new use for medicine
PIL updated Hydrea 500 mg Hard Capsules
Active Ingredients: Hydroxycarbamide
Company: Bristol-Myers Squibb Pharmaceuticals Ltd | Document History
  • Change due to user-testing of patient information
  • Change to name of manufacturer
PIL updated Inactivated Influenza Vaccine (Split Virion) BP
Active Ingredients: Influenza Vaccine
Company: Sanofi Pasteur MSD Limited | Document History
  • Change to further information section
SPC updated Metvix Cream
Active Ingredients: Methyl Aminolevulinate Hydrochloride
Company: Galderma (U.K) Ltd | Document History
  • Change to section 6.3 - Shelf life
PIL updated Night Nurse Capsules
Active Ingredients: Paracetamol, Promethazine hydrochloride, Dextromethorphan Hydrobromide
Company: GlaxoSmithKline Consumer Healthcare (Ireland) Ltd | Document History
  • Change to further information section
  • Change to date of revision
  • Change due to user-testing of patient information
SPC updated Pentacarinat Ready-to-Use 300mg/5ml nebuliser solution
Active Ingredients: Pentamidine Isethionate
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
  • 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 10 - Date of revision of the text
SPC updated Tarceva 25mg, 100mg and 150mg Film-Coated Tablets
Active Ingredients: Erlotinib hydrochloride
Company: Roche Products (Ireland) Ltd | Document History
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
PIL updated Vepesid Soft Capsules 50 mg & 100 mg
Active Ingredients: Etoposide
Company: Bristol-Myers Squibb Pharmaceuticals Ltd | Document History
  • Change due to user-testing of patient information
  • Change to name of manufacturer
SPC updated Xolair 150mg Powder and Solvent for Solution for Injection
Active Ingredients: Omalizumab
Company: Novartis Ireland Limited | Document History
  • Addition of legal category
01 September 2010
New 4, Updated 14, Retired 0, [Total 18]
PIL updated Canesten HC Cream
Active Ingredients: Hydrocortisone, Clotrimazole
Company: Bayer Limited | Document History
  • Change of licence holder
  • Change to date of revision
SPC updated GARDASIL
Active Ingredients: human papillomavirus vaccine
Company: Sanofi Pasteur MSD Limited | Document History
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
SPC new Janumet 50 mg/1000 mg film-coated tablets
Active Ingredients: Metformin Hydrochloride, sitagliptin phosphate monohydrate
Company: Merck Sharp & Dohme Ireland (Human Health) Limited
  • New individual SPC (was previously included in combined SPC)
SPC updated Janumet 50 mg/850 mg film-coated tablets
Active Ingredients: Metformin Hydrochloride, sitagliptin phosphate monohydrate
Company: Merck Sharp & Dohme Ireland (Human Health) Limited | Document History
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • 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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 8 - MA number
  • Change to separate SPCs covering individual presentations
SPC updated JANUVIA 100mg
Active Ingredients: sitagliptin phosphate monohydrate
Company: Merck Sharp & Dohme Ireland (Human Health) Limited | Document History
  • Change to section 4.1 - Therapeutic indications
  • 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 4.6 - 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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
SPC updated Rocaltrol 0.25mcg Soft Capsules
Active Ingredients: Calcitriol
Company: Roche Products (Ireland) Ltd | Document History
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
SPC updated Singulair Paediatric 4 mg Chewable Tablets
Active Ingredients: Montelukast Sodium
Company: Merck Sharp & Dohme Ireland (Human Health) Limited | Document History
  • Change to section 4.8 - Undesirable effects
SPC updated SINGULAIR Paediatric 5 mg Chewable Tablets
Active Ingredients: Montelukast Sodium
Company: Merck Sharp & Dohme Ireland (Human Health) Limited | Document History
  • Change to section 4.8 - Undesirable effects
SPC updated SINGULAIR Tablets
Active Ingredients: Montelukast Sodium
Company: Merck Sharp & Dohme Ireland (Human Health) Limited | Document History
  • Change to section 4.8 - Undesirable effects
SPC new Stelara 45 & 90 mg solution for injection in pre-filled syringe
Active Ingredients: Ustekinumab
Company: Janssen-Cilag Ltd
  • New SPC for new product
PIL new Stelara 45 mg solution for injection in pre-filled syringe
Active Ingredients: Ustekinumab
Company: Janssen-Cilag Ltd
  • New PIL for new product
PIL new Stelara 90 mg solution for injection in pre-filled syringe
Active Ingredients: Ustekinumab
Company: Janssen-Cilag Ltd
  • New PIL for new product
SPC updated Tamsulosin 400 micrograms Modified-Release Capsules
Active Ingredients: Tamsulosin Hydrochloride
Company: Gerard Laboratories | Document History
  • 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 10 - Date of revision of the text
PIL updated Tamsulosin 400 micrograms Modified-Release Capsules
Active Ingredients: Tamsulosin Hydrochloride
Company: Gerard Laboratories | Document History
  • Change to side-effects
  • Change to date of revision
SPC updated Teveten 400mg
Active Ingredients: Eprosartan mesilate
Company: Solvay Healthcare Limited | Document History
  • Change to section 6.3 - Shelf life
SPC updated Trental Tablets
Active Ingredients: Pentoxifylline
Company: sanofi-aventis | Document History
  • Change to section 6.3 - Shelf life
SPC updated Xyzal 0.5mg/ml oral solution
Active Ingredients: Levocetirizine dihydrochloride
Company: UCB (Pharma) Ireland Limited | Document History
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
SPC updated Xyzal 5mg/ml Oral Drops, Solution
Active Ingredients: Levocetirizine dihydrochloride
Company: UCB (Pharma) Ireland Limited | Document History
  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.8 - Undesirable effects
31 August 2010
New 6, Updated 12, Retired 1, [Total 19]
PIL updated Alvesco 80 micrograms & Alvesco 160 micrograms pressurised inhalation, solution
Active Ingredients: Ciclesonide
Company: Nycomed Products Ltd | Document History
  • Improved electronic presentation
PIL updated Clopixol Acuphase Injection
Active Ingredients: Zuclopenthixol acetate
Company: Lundbeck (Ireland) Limited | Document History
  • Change to side-effects
PIL updated Depixol Injection
Active Ingredients: Flupentixol Decanoate
Company: Lundbeck (Ireland) Limited | Document History
  • Correction of spelling/typing errors
PIL updated Depixol Injection 200mg/ml
Active Ingredients: Flupentixol Decanoate
Company: Lundbeck (Ireland) Limited | Document History
  • Correction of spelling/typing errors
PIL updated INNOZIDE TABLETS
Active Ingredients: Hydrochlorothiazide, Enalapril Maleate
Company: Merck Sharp & Dohme Ireland (Human Health) Limited | Document History
  • Change to information about pregnancy or lactation
PIL updated Lexapro Tablets
Active Ingredients: Escitalopram Oxalate
Company: Lundbeck (Ireland) Limited | Document History
  • Introduction of new pack/pack size
SPC updated Minims Oxybuprocaine Hydrochloride 0.4% w/v eye drop solution
Active Ingredients: Oxybuprocaine Hydrochloride
Company: Chauvin Pharmaceuticals Ltd | Document History
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 9 - Date of renewal of authorisation
PIL new Neupro 1mg/24hr Transdermal Patch
Active Ingredients: Rotigotine
Company: Schwarz Pharma Limited
  • New PIL for medicines.ie
PIL new Neupro 2mg/24hr Transdermal Patch
Active Ingredients: Rotigotine
Company: Schwarz Pharma Limited
  • New PIL for medicines.ie
PIL new Neupro 3mg/24hr Transdermal Patch
Active Ingredients: Rotigotine
Company: Schwarz Pharma Limited
  • New PIL for medicines.ie
PIL new Neupro 4mg/24hr Transdermal Patch
Active Ingredients: Rotigotine
Company: Schwarz Pharma Limited
  • New PIL for medicines.ie
PIL new Neupro 6mg/24hr Transdermal Patch
Active Ingredients: Rotigotine
Company: Schwarz Pharma Limited
  • New PIL for medicines.ie
PIL new Neupro 8mg/24hr Transdermal Patch
Active Ingredients: Rotigotine
Company: Schwarz Pharma Limited
  • New PIL for medicines.ie
PIL updated Risperdal 0.5, 1, 2, 3, 4 and 6 mg film-coated tablets, Risperdal Quicklet 0.5,1,2,3 and 4 mg orodispersible tablets
Active Ingredients: Risperidone
Company: Janssen-Cilag Ltd | Document History
  • Change to date of revision
  • Change due to user-testing of patient information, Addition of joint PIL covering all presentations
PIL updated RISPERDAL CONSTA 25, 37.5, 50 mg powder and solvent for prolonged-release suspension for intramuscular injection
Active Ingredients: Risperidone
Company: Janssen-Cilag Ltd | Document History
  • Change to date of revision
  • Change due to user-testing of patient information
PIL updated Risperdal Liquid 1 mg/ml oral solution
Active Ingredients: Risperidone
Company: Janssen-Cilag Ltd | Document History
  • Change to date of revision
  • Change due to user-testing of patient information
PIL retired Risperdal Quicklet 0.5, 1, 2, 3 and 4mg orodispersible tablets
Active Ingredients: Risperidone
Company: Janssen-Cilag Ltd
  • Individual presentations superceeded by joint PIL
PIL updated Thyrogen 0.9 mg powder for solution for injection
Active Ingredients: Thyrotropin alfa
Company: Genzyme Therapeutics | Document History
  • Change to further information section
PIL updated Vertigon 8mg & 16mg Tablets
Active Ingredients: Betahistine dihydrochloride
Company: Gerard Laboratories | Document History
  • Change due to harmonisation of PIL