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Document information 17/05/2012 17:55
Current documents
SPC 2221
PIL 1934
Total: 4155
Submissions in the last 3 months
Updated: 686
New: 91

 

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
17 May 2012
New 0, Updated 16, Retired 0, [Total 16]
PIL updated Adalat 10 mg capsules
Active Ingredients: Nifedipine
Company: Bayer Limited | Document History
  • Change to name of manufacturer
PIL updated Adalat 5mg Capsules
Active Ingredients: Nifedipine
Company: Bayer Limited | Document History
  • Change to name of manufacturer
PIL updated Adalat Retard 10 mg
Active Ingredients: Nifedipine
Company: Bayer Limited | Document History
  • Change to name of manufacturer
PIL updated Adalat Retard 20 mg
Active Ingredients: Nifedipine
Company: Bayer Limited | Document History
  • Change to name of manufacturer
PIL updated Cipramil Drops 40mg/ml
Active Ingredients: citalopram hydrochloride
Company: Lundbeck (Ireland) Limited | Document History
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to instructions about overdose
  • Change to side-effects
  • Change to drug interactions
  • 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
  • Change to dosage and administration
  • Change due to user-testing of patient information, Correction of spelling/typing errors
SPC updated Cipramil Drops 40mg/ml
Active Ingredients: citalopram hydrochloride
Company: Lundbeck (Ireland) Limited | Document History
  • Change to section 4 - Clinical particulars
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
PIL updated Cipramil Tablets
Active Ingredients: citalopram hydrobromide
Company: Lundbeck (Ireland) Limited | Document History
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to instructions about overdose
  • Change to side-effects
  • Change to drug interactions
  • 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
  • Change due to user-testing of patient information, Correction of spelling/typing errors
SPC updated Cipramil Tablets
Active Ingredients: citalopram hydrobromide
Company: Lundbeck (Ireland) Limited | Document History
  • Change to section 4 - Clinical particulars
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
PIL updated Clopixol Acuphase Injection
Active Ingredients: Zuclopenthixol acetate
Company: Lundbeck (Ireland) Limited | Document History
  • Change to information about pregnancy or lactation
PIL updated Clopixol Conc. Injection 500 mg/ml
Active Ingredients: Zuclopenthixol decanoate
Company: Lundbeck (Ireland) Limited | Document History
  • Change to information about pregnancy or lactation
PIL updated Clopixol Injection 200 mg/ml
Active Ingredients: Zuclopenthixol decanoate
Company: Lundbeck (Ireland) Limited | Document History
  • Change to information about pregnancy or lactation
PIL updated Clopixol Tablets
Active Ingredients: Zuclopenthixol dihydrochloride
Company: Lundbeck (Ireland) Limited | Document History
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to instructions about overdose
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to how the medicine works
  • Change to date of revision
  • Change to dosage and administration
  • Change due to user-testing of patient information, Correction of spelling/typing errors
SPC updated INVEGA 1.5 mg, 3 mg, 6 mg, 9 mg, 12 mg prolonged-release tablets
Active Ingredients: Paliperidone
Company: Janssen-Cilag Ltd | Document History
  • Change to section 3 - Pharmaceutical form
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
  • Change to section 6.6 - Special precautions for disposal and other handling
PIL updated INVEGA 1.5 mg, 3 mg, 6 mg, 9 mg, 12 mg prolonged-release tablets
Active Ingredients: Paliperidone
Company: Janssen-Cilag Ltd | Document History
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to date of revision
PIL updated Serdolect Film-coated Tablets
Active Ingredients: Sertindole
Company: Lundbeck (Ireland) Limited | Document History
  • Correction of spelling/typing errors
SPC updated Veno's Honey and Lemon
Active Ingredients: Ammonium Chloride, Ipecacuanha Liquid Extract, Liquid Glucose, Honey, Lemon Juice
Company: Forest Laboratories UK Limited | Document History
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
16 May 2012
New 0, Updated 9, Retired 0, [Total 9]
PIL updated Canesten 500mg Pessary
Active Ingredients: Clotrimazole
Company: Bayer Limited | Document History
  • Change to date of revision
  • Change to name of manufacturer
PIL updated Depixol Conc. Injection
Active Ingredients: Flupentixol Decanoate
Company: Lundbeck (Ireland) Limited | Document History
  • Change to information about pregnancy or lactation
PIL updated Depixol Injection
Active Ingredients: Flupentixol Decanoate
Company: Lundbeck (Ireland) Limited | Document History
  • Change to information about pregnancy or lactation
PIL updated Depixol Injection 200mg/ml
Active Ingredients: Flupentixol Decanoate
Company: Lundbeck (Ireland) Limited | Document History
  • Change to information about pregnancy or lactation
PIL updated GARDASIL
Active Ingredients: human papillomavirus vaccine
Company: Sanofi Pasteur MSD Limited | Document History
  • Change to side-effects
SPC updated Humalog Vial, Cartridge, and KwikPen 100U/ml
Active Ingredients: Insulin lispro
Company: Eli Lilly and Company (Ireland) Limited | Document History
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
PIL updated IRESSA 250 mg film-coated tablets
Active Ingredients: gefitinib
Company: AstraZeneca Pharmaceuticals (Ireland) Ltd | Document History
  • Change to side-effects
  • Change to date of revision, Improved electronic presentation
SPC updated IRESSA 250 mg film-coated tablets
Active Ingredients: gefitinib
Company: AstraZeneca Pharmaceuticals (Ireland) Ltd | Document History
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
SPC updated Ventavis 10 microgram/ml nebuliser solution
Active Ingredients: iloprost trometamol
Company: Bayer 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 4.6 - Pregnancy and lactation
  • 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 5.3 - Preclinical safety data
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
15 May 2012
New 1, Updated 16, Retired 0, [Total 17]
PIL updated AMIKIN INJECTION 100MG/2ML
Active Ingredients: Amikacin Sulphate
Company: Bristol-Myers Squibb Holdings Limited | Document History
  • Change to date of revision
  • Change to dosage and administration
PIL updated Amoxil Vial for Injection 500mg
Active Ingredients: Amoxicillin sodium
Company: GlaxoSmithKline (Ireland) Ltd | Document History
  • Change due to user-testing of patient information
SPC updated Betoptic Suspension Single Dose 0.25%
Active Ingredients: Betaxolol Hydrochloride
Company: Alcon Laboratories (U.K) Limited | Document History
  • 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 4.8 - Undesirable effects
PIL updated Canesten 200mg Pessary
Active Ingredients: Clotrimazole
Company: Bayer Limited | Document History
  • Change to date of revision
  • Change to name of manufacturer
SPC updated Dalacin C Phosphate 150mg/ml Concentrate for Solution for infusion or Solution for Injection, 2ml and 4ml
Active Ingredients: Clindamycin Phosphate
Company: Pfizer Healthcare Ireland | Document History
  • 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
SPC updated Duac
Active Ingredients: Clindamycin Phosphate, Benzoyl Peroxide, hydrous
Company: Stiefel Ireland | Document History
  • Change to section 6.5 - Nature and contents of container
SPC updated FOSAVANCE 70mg/2800 IU Tablets
Active Ingredients: Colecalciferol (Vitamin D3), Alendronate Sodium Trihydrate
Company: MSD Ireland (Human Health) Limited | Document History
  • Change to section 4.7 - Effects on ability to drive and use machines
PIL updated Influvac Sub-unit 2011-2012, suspension for injection
Active Ingredients: Influenza vaccine (surface antigen, inactivated)
Company: Abbott Healthcare Products Limited | Document History
  • Change of contraindications
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to date of revision
  • Change to dosage and administration
PIL updated Logynon Tablets
Active Ingredients: Ethinyloestradiol, Levonorgestrel
Company: Bayer Limited | Document History
  • Change of manufacturer
PIL updated Night Nurse Capsules
Active Ingredients: Paracetamol, Promethazine hydrochloride, Dextromethorphan Hydrobromide
Company: GlaxoSmithKline Consumer Healthcare (Ireland) Ltd | Document History
  • Change to storage instructions
PIL updated Night Nurse Cold Remedy
Active Ingredients: Paracetamol, Promethazine hydrochloride, Dextromethorphan Hydrobromide
Company: GlaxoSmithKline Consumer Healthcare (Ireland) Ltd | Document History
  • Change to warnings or special precautions for use
  • Change to storage instructions
SPC updated Nizoral Cream
Active Ingredients: Ketoconazole
Company: McNeil Healthcare (Ireland) Ltd | Document History
  • Change to section 4.4 - Special warnings and precautions for use
SPC new Peyona (caffeine citrate) 20 mg/ml solution for infusion and oral solution
Active Ingredients: Caffeine citrate
Company: Chiesi Limited
  • New SPC for new product
SPC updated Serdolect Film-coated Tablets
Active Ingredients: Sertindole
Company: Lundbeck (Ireland) Limited | Document History
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
SPC updated Zismirt 30 mg Film-Coated Tablets
Active Ingredients: Mirtazapine
Company: Gerard Laboratories | Document History
  • 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
PIL updated Zismirt 30 mg Film-Coated Tablets
Active Ingredients: Mirtazapine
Company: Gerard Laboratories | Document History
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to instructions about missed dose
  • Change to side-effects
  • Change to information about drinking alcohol
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
SPC updated Zonegran capsules
Active Ingredients: Zonisamide
Company: Eisai Ltd | Document History
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text