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Document information 23/05/2013 04:54
Current documents
SPC 2310
PIL 1959
Total: 4269
Submissions in the last 3 months
Updated: 857
New: 81

 

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
22 May 2013
New 2, Updated 6, Retired 0, [Total 8]
SPC new Bisoprolol 5mg or 10mg film-coated tablets
Active Ingredients: Bisoprolol Fumarate
Company: Gerard Laboratories
  • New SPC for new product, New SPC for medicines.ie
SPC new Cayston 75 mg powder and solvent for nebuliser solution
Active Ingredients: Aztreonam lysine
Company: Gilead Sciences Ltd
  • New SPC for medicines.ie
SPC updated Esmeron
Active Ingredients: Rocuronium Bromide
Company: MSD 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 4.8 - 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 6.4 - Special precautions for storage
SPC updated Myozyme 50 mg, powder for concentrate for solution for infusion.
Active Ingredients: Alglucosidase alfa
Company: Genzyme Therapeutics | Document History
  • Change to section 6.3 - Shelf life
SPC updated Valsartan Mylan 160 mg Film-coated Tablets
Active Ingredients: Valsartan
Company: Gerard Laboratories | 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
SPC updated Valsartan Mylan 320 mg Film-coated Tablets
Active Ingredients: Valsartan
Company: Gerard Laboratories | 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
SPC updated Valsartan Mylan 40 mg Film-coated Tablets
Active Ingredients: Valsartan
Company: Gerard Laboratories | 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
SPC updated Valsartan Mylan 80 mg Film-coated Tablets
Active Ingredients: Valsartan
Company: Gerard Laboratories | 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
21 May 2013
New 0, Updated 13, Retired 0, [Total 13]
PIL updated Anthisan Cream
Active Ingredients: Mepyramine Maleate
Company: SANOFI | Document History
  • Change of manufacturer
  • Change to marketing authorisation holder
PIL updated Bisoprolol 5mg or 10mg film-coated tablets
Active Ingredients: Bisoprolol Fumarate
Company: Gerard Laboratories | Document History
  • Change to date of revision, Correction of spelling/typing errors
SPC updated Ditropan 5mg Tablets
Active Ingredients: Oxybutynin Hydrochloride
Company: SANOFI | Document History
  • Change to section 6.5 - Nature and contents of container
SPC updated Mucodyne 375mg Capsules
Active Ingredients: Carbocisteine
Company: SANOFI | Document History
  • Change to section 4.8 - Undesirable effects
SPC updated Mucodyne Syrup
Active Ingredients: Carbocisteine
Company: SANOFI | Document History
  • Change to section 4.8 - Undesirable effects
SPC updated Pulmicort Respules 0.5mg
Active Ingredients: Budesonide
Company: AstraZeneca Pharmaceuticals (Ireland) Ltd | Document History
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - 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 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
SPC updated Pulmicort Respules 1mg
Active Ingredients: Budesonide
Company: AstraZeneca Pharmaceuticals (Ireland) Ltd | Document History
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - 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 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
SPC updated Pulmicort Turbohaler 100
Active Ingredients: Budesonide
Company: AstraZeneca Pharmaceuticals (Ireland) Ltd | 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 4.6 - 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 10 - Date of revision of the text
SPC updated Pulmicort Turbohaler 200
Active Ingredients: Budesonide
Company: AstraZeneca Pharmaceuticals (Ireland) Ltd | 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 4.6 - 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 10 - Date of revision of the text
SPC updated Pulmicort Turbohaler 400
Active Ingredients: Budesonide
Company: AstraZeneca Pharmaceuticals (Ireland) Ltd | 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 4.6 - 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 10 - Date of revision of the text
SPC updated Triapin 2.5mg/2.5mg prolonged release tablet
Active Ingredients: Felodipine, Ramipril
Company: SANOFI | Document History
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
SPC updated Triapin 5mg/5mg prolonged release tablet
Active Ingredients: Felodipine, Ramipril
Company: SANOFI | Document History
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
SPC updated Trobalt film coated tablets
Active Ingredients: Retigabine
Company: GlaxoSmithKline (Ireland) Ltd | Document History
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 7 - Marketing authorisation holder
20 May 2013
New 1, Updated 10, Retired 1, [Total 12]
SPC updated BENETOR 10mg, 20 mg and 40 mg film-coated tablets
Active Ingredients: olmesartan medoxomil
Company: Daiichi Sankyo Ireland Ltd | Document History
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • 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
PIL new Cayston 75 mg powder and solvent for nebuliser solution
Active Ingredients: Aztreonam lysine
Company: Gilead Sciences Ltd
  • New PIL for medicines.ie
SPC updated Dalacin T Topical Solution
Active Ingredients: Clindamycin Phosphate
Company: Pfizer Healthcare Ireland | Document History
  • Change to section 7 - Marketing authorisation holder
PIL updated Evorel Conti
Active Ingredients: Estradiol Hemihydrate, Norethisterone acetate
Company: Janssen-Cilag Ltd | Document History
  • Change to side-effects
  • Change to date of revision
SPC updated Evorel Conti
Active Ingredients: Estradiol Hemihydrate, Norethisterone acetate
Company: Janssen-Cilag Ltd | Document History
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
SPC updated INEGY Tablets
Active Ingredients: Simvastatin, ezetimibe
Company: MSD Ireland (Human Health) 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 10 - Date of revision of the text
SPC updated Maxidex Eye Drops
Active Ingredients: Dexamethasone
Company: Alcon Laboratories (U.K) 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 10 - Date of revision of the text
SPC updated Maxidex Ointment
Active Ingredients: Dexamethasone
Company: Alcon Laboratories (U.K) 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 10 - Date of revision of the text
SPC updated Nu-Seals 75
Active Ingredients: Aspirin
Company: Alliance Pharmaceuticals Ireland | Document History
  • Change to section 6.3 - Shelf life
PIL updated Regaine for Men Extra Strength Scalp Foam 5%w/w
Active Ingredients: Minoxidil
Company: McNeil Healthcare (Ireland) Ltd | Document History
  • Change to side-effects
SPC retired ReQuip Tablets
Active Ingredients: ropinirole hydrochloride
Company: GlaxoSmithKline (Ireland) Ltd
  • Joint SPC superseded by SPCs for individual presentations
PIL updated Trobalt 50mg/100mg/200mg/300mg/400mg Film Coated Tablets
Active Ingredients: Retigabine
Company: GlaxoSmithKline (Ireland) Ltd | Document History
  • Change to MA holder contact details