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Document information 09/02/2012 07:49
Current documents
SPC 2222
PIL 1888
Total: 4110
Submissions in the last 3 months
Updated: 747
New: 73

 

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
08 February 2012
New 1, Updated 11, Retired 2, [Total 14]
PIL updated Cozaar COMP 50 mg/12.5 mg, 100 mg/12.5 mg, 100 mg/25 mg film-coated tablets
Active Ingredients: Hydrochlorothiazide, Losartan potassium
Company: Merck Sharp & Dohme Ireland (Human Health) Limited | Document History
  • Change to information about pregnancy or lactation
  • Change to improve clarity and readability
PIL updated EFEXOR XL
Active Ingredients: venlafaxine hydrochloride
Company: Wyeth Pharmaceuticals | Document History
  • Change to side-effects
  • Change to date of revision
PIL retired Integrilin 0.75 mg/ml, solution for infusion
Active Ingredients: Eptifibatide
Company: GlaxoSmithKline (Ireland) Ltd
  • Presentation currently not marketed.
PIL retired Integrilin 2mg/ml, solution for infusion
Active Ingredients: Eptifibatide
Company: GlaxoSmithKline (Ireland) Ltd
  • Presentation currently not marketed.
PIL new NULOJIX 250 mg powder for concentrate for solution for infusion
Active Ingredients: Belatacept
Company: Bristol-Myers Squibb Pharmaceutical Limited
  • New PIL for new product, New PIL for medicines.ie
PIL updated Nurofen 200mg Liquid Capsules
Active Ingredients: Ibuprofen
Company: Reckitt Benckiser Ireland Limited | Document History
  • Change due to user-testing of patient information
PIL updated OxyNorm liquid 1 mg/ml oral solution
Active Ingredients: Oxycodone Hydrochloride
Company: Mundipharma Pharmaceuticals Limited - Formerly Napp Laboratories | Document History
  • Change to marketing authorisation holder
PIL updated Panadeine Tablets Paracetamol 500mg Codeine Phosphate Hemihydrate 8mg
Active Ingredients: Paracetamol, Codeine Phosphate Hemihydrate
Company: GlaxoSmithKline Consumer Healthcare (Ireland) Ltd | Document History
  • Change to information about pregnancy or lactation
  • Change to date of revision
PIL updated Panadol Max Strength, Cold and Flu Hot Lemon, Powder for Oral Solution, Paracetamol 1000mg
Active Ingredients: Paracetamol
Company: GlaxoSmithKline Consumer Healthcare (Ireland) Ltd | Document History
  • Change to side-effects
  • Change to date of revision
PIL updated Solpadeine Capsules
Active Ingredients: Paracetamol, Caffeine, Codeine Phosphate Hemihydrate
Company: GlaxoSmithKline Consumer Healthcare (Ireland) Ltd | Document History
  • Change to information about pregnancy or lactation
  • Change to date of revision
PIL updated Solpadeine Soluble Tablets
Active Ingredients: Paracetamol, Caffeine, Codeine Phosphate Hemihydrate
Company: GlaxoSmithKline Consumer Healthcare (Ireland) Ltd | Document History
  • Change to information about pregnancy or lactation
  • Change to date of revision
PIL updated Solpadeine Tablets
Active Ingredients: Paracetamol, Caffeine, Codeine Phosphate Hemihydrate
Company: GlaxoSmithKline Consumer Healthcare (Ireland) Ltd | Document History
  • Change to information about pregnancy or lactation
  • Change to date of revision
PIL updated Yondelis 0.25 mg powder for concentrate for solution for infusion/Yondelis 1 mg powder for concentrate for solution for infusion
Active Ingredients: Trabectedin
Company: Pharma Mar, S.A. | Document History
  • 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 further information section
  • Change to date of revision
  • Change to dosage and administration
PIL updated Zismirt orotab 15mg, 30mg & 45mg Orodispersible Tablets
Active Ingredients: Mirtazapine
Company: Gerard Laboratories | Document History
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to further information section
07 February 2012
New 1, Updated 7, Retired 0, [Total 8]
PIL updated Lioresal 5mg/5ml Oral Solution
Active Ingredients: Baclofen
Company: Novartis Ireland Limited | Document History
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Change to dosage and administration
SPC new NULOJIX 250 mg powder for concentrate for solution for infusion
Active Ingredients: Belatacept
Company: Bristol-Myers Squibb Pharmaceutical Limited
  • New SPC for new product, New SPC for medicines.ie
PIL updated Slow K Tablets
Active Ingredients: Potassium Chloride
Company: Novartis Ireland Limited | Document History
  • Change due to user-testing of patient information
SPC updated Solaraze 3% Gel
Active Ingredients: Diclofenac Sodium
Company: Almirall Limited | Document History
  • 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
PIL updated Viramune 400 mg Prolonged-Release Tablets
Active Ingredients: nevirapine anhydrate
Company: Boehringer Ingelheim Limited | Document History
  • Change to date of revision
  • Change to MA holder contact details
PIL updated Viramune 50 mg and 100 mg Prolonged-Release Tablets
Active Ingredients: nevirapine anhydrate
Company: Boehringer Ingelheim Limited | Document History
  • Change to date of revision
  • Change to MA holder contact details
PIL updated Viramune Suspension
Active Ingredients: nevirapine hemihydrate
Company: Boehringer Ingelheim Limited | Document History
  • Change to warnings or special precautions for use
  • Change to instructions about missed dose
  • Change to date of revision
  • Change to MA holder contact details
PIL updated Viramune Tablets
Active Ingredients: Nevirapine
Company: Boehringer Ingelheim Limited | Document History
  • Change to warnings or special precautions for use
  • Change to instructions about missed dose
  • Change to date of revision
  • Change to MA holder contact details
06 February 2012
New 0, Updated 9, Retired 0, [Total 9]
SPC updated Advil Liquigels, 200mg Capsules
Active Ingredients: Ibuprofen
Company: Pfizer Consumer Healthcare | Document History
  • Change to section 6.1 - List of excipients
SPC updated CHAMPIX 0.5 mg film-coated tablets; CHAMPIX 1 mg film-coated tablets
Active Ingredients: Varenicline tartrate
Company: Pfizer Healthcare Ireland | Document History
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
PIL updated Dynastat 20 mg and 40 mg Powder for Solution for Injection
Active Ingredients: Parecoxib sodium
Company: Pfizer Healthcare Ireland | Document History
  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Change to dosage and administration
SPC updated Dynastat 20mg and 40 mg powder for solution for injection and Dynastat 20mg and 40 mg powder and solvent for solution for injection
Active Ingredients: Parecoxib sodium
Company: Pfizer Healthcare Ireland | Document History
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 6.3 - Shelf life
SPC updated Kentera oxybutynin transdermal patch
Active Ingredients: Oxybutynin
Company: Recordati Ireland Limited | Document History
  • Change to section 10 - Date of revision of the text
  • Change of distributor details
SPC updated Nicorette Icy White 2mg Chewing Gum
Active Ingredients: Nicotine
Company: McNeil Healthcare (Ireland) Ltd | Document History
  • Change to section 6.1 - List of excipients
SPC updated Nicorette Icy White 4mg Chewing Gum
Active Ingredients: Nicotine
Company: McNeil Healthcare (Ireland) Ltd | Document History
  • Change to section 6.1 - List of excipients
SPC updated Resolor 1 mg film-coated tablets
Active Ingredients: Prucalopride Succinate
Company: Shire Pharmaceuticals Ireland Limited | Document History
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
SPC updated Resolor 2 mg film-coated tablets
Active Ingredients: Prucalopride Succinate
Company: Shire Pharmaceuticals Ireland Limited | Document History
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction