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Document information 28/01/2012 19:25
Current documents
SPC 2217
PIL 1890
Total: 4107
Submissions in the last 3 months
Updated: 719
New: 66

 

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
27 January 2012
New 0, Updated 19, Retired 0, [Total 19]
PIL updated Adenuric film-coated tablets
Active Ingredients: febuxostat
Company: A.Menarini Pharmaceuticals Ltd | Document History
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • 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 improve clarity and readability, Correction of spelling/typing errors
PIL updated AMIKIN INJECTION 100MG/2ML
Active Ingredients: Amikacin Sulphate
Company: Bristol-Myers Squibb Holdings Limited | Document History
  • Correction of spelling/typing errors
SPC updated Budenofalk 9mg gastro-resistant granules
Active Ingredients: Budesonide
Company: Dr. Falk Pharma UK Ltd | Document History
  • Change to section 8 - MA number
PIL updated Canesten Cream
Active Ingredients: Clotrimazole
Company: Bayer Limited | Document History
  • Change to side-effects
PIL updated Canesten Thrush Cream
Active Ingredients: Clotrimazole
Company: Bayer Limited | Document History
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
SPC updated Copegus 200mg and 400mg Film-coated Tablets
Active Ingredients: Ribavirin
Company: Roche Products (Ireland) Ltd | 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
SPC updated Effentora 100, 200, 400, 600 and 800 micrograms buccal tablets
Active Ingredients: fentanyl citrate
Company: Cephalon Pharma (Ireland) Ltd | Document History
  • Change to section 4.4 - Special warnings and precautions for use
SPC updated Eucardic 12.5mg Tablets
Active Ingredients: Carvedilol
Company: Roche Products (Ireland) Ltd | Document History
  • 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 Eucardic 25mg Tablets
Active Ingredients: Carvedilol
Company: Roche Products (Ireland) Ltd | Document History
  • 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 Eucardic 3.125mg Tablets
Active Ingredients: Carvedilol
Company: Roche Products (Ireland) Ltd | Document History
  • 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 Eucardic 6.25mg Tablets
Active Ingredients: Carvedilol
Company: Roche Products (Ireland) Ltd | Document History
  • 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 INCRELEX
Active Ingredients: Mecasermin
Company: Ipsen Pharmaceuticals Ltd | Document History
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
PIL updated Orgalutran
Active Ingredients: Ganirelix
Company: Organon Laboratories Limited | Document History
  • Change to further information section
  • Change to date of revision
PIL updated Retrovir Capsules 100mg
Active Ingredients: Zidovudine
Company: ViiV Healthcare UK Ltd | Document History
  • Change to MA holder contact details
PIL updated Retrovir Tablets 300mg
Active Ingredients: Zidovudine
Company: ViiV Healthcare UK Ltd | Document History
  • Change to MA holder contact details
SPC updated Stelara 45 & 90 mg solution for injection in pre-filled syringe
Active Ingredients: Ustekinumab
Company: Janssen-Cilag Ltd | Document History
  • Change to section 4.2 - Posology and method of administration
  • 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 10 - Date of revision of the text
PIL updated Stelara 45 mg solution for injection in pre-filled syringe
Active Ingredients: Ustekinumab
Company: Janssen-Cilag Ltd | Document History
  • Change of contraindications
  • Change to side-effects
PIL updated Stelara 90 mg solution for injection in pre-filled syringe
Active Ingredients: Ustekinumab
Company: Janssen-Cilag Ltd | Document History
  • Change of contraindications
  • Change to side-effects
PIL updated SUTENT 12.5mg, 25mg, 37.5mg and 50mg Hard Capsules
Active Ingredients: Sunitinib malate
Company: Pfizer Healthcare Ireland | Document History
  • Correction of spelling/typing errors
26 January 2012
New 2, Updated 16, Retired 7, [Total 25]
SPC retired Amoxil Capsules 250mg
Active Ingredients: Amoxicillin trihydrate
Company: GlaxoSmithKline (Ireland) Ltd
  • SPC Product / presentation discontinued
PIL retired Amoxil Capsules 250mg & 500mg x 21
Active Ingredients: Amoxicillin trihydrate
Company: GlaxoSmithKline (Ireland) Ltd
  • PIL product / presentation discontinued
SPC retired Amoxil Capsules 500mg
Active Ingredients: Amoxycillin
Company: GlaxoSmithKline (Ireland) Ltd
  • SPC Product / presentation discontinued
SPC updated Amoxil Paediatric Suspension
Active Ingredients: Amoxicillin trihydrate
Company: GlaxoSmithKline (Ireland) Ltd | Document History
  • Change to section 6.1 - List of excipients
PIL retired Amoxil Syrup 125mg/5ml
Active Ingredients: Amoxicillin trihydrate
Company: GlaxoSmithKline (Ireland) Ltd
  • PIL product / presentation discontinued
SPC retired Amoxil Syrup 125mg/5ml
Active Ingredients: Amoxicillin trihydrate
Company: GlaxoSmithKline (Ireland) Ltd
  • SPC Product / presentation discontinued
SPC retired Amoxil Syrup Forte 250mg/5ml
Active Ingredients: Amoxicillin trihydrate
Company: GlaxoSmithKline (Ireland) Ltd
  • SPC Product / presentation discontinued
PIL retired Amoxil Syrup Forte 250mg/5ml
Active Ingredients: Amoxicillin trihydrate
Company: GlaxoSmithKline (Ireland) Ltd
  • PIL product / presentation discontinued
SPC updated Competact
Active Ingredients: Metformin Hydrochloride, pioglitazone hydrochloride
Company: Takeda UK Ltd | Document History
  • Correction of spelling/typing errors
SPC updated Cystopurin 3g Granules for Oral Solution
Active Ingredients: Potassium Citrate
Company: Bayer Limited | Document History
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
SPC new Decapeptyl 6 Month
Active Ingredients: triptorelin pamoate
Company: Ipsen Pharmaceuticals Ltd
  • New SPC for new product
SPC updated Gyno-Daktarin 1200mg Vaginal Capsules
Active Ingredients: Miconazole nitrate
Company: Janssen-Cilag Ltd | Document History
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text
PIL updated INCRELEX
Active Ingredients: Mecasermin
Company: Ipsen Pharmaceuticals Ltd | Document History
  • Change due to user-testing of patient information, Correction of spelling/typing errors
PIL updated Neulasta with needle guard
Active Ingredients: Pegfilgrastim
Company: Amgen Ltd | Document History
  • Change due to user-testing of patient information
PIL updated NutropinAq
Active Ingredients: Somatropin
Company: Ipsen Pharmaceuticals Ltd | Document History
  • Change due to user-testing of patient information
SPC updated NutropinAq
Active Ingredients: Somatropin
Company: Ipsen Pharmaceuticals 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 4.8 - Undesirable effects
  • Change to section 6.2 - Incompatibilities
  • Change to section 7 - Marketing authorisation holder
PIL updated PALLADONE capsules
Active Ingredients: Hydromorphone Hydrochloride
Company: Mundipharma Pharmaceuticals Limited - Formerly Napp Laboratories | Document History
  • Change to side-effects
  • Change to date of revision
  • Change to marketing authorisation holder
PIL updated Palladone SR Capsules
Active Ingredients: Hydromorphone Hydrochloride
Company: Mundipharma Pharmaceuticals Limited - Formerly Napp Laboratories | Document History
  • Change to side-effects
  • Change to further information section
  • Change to date of revision
  • Change to marketing authorisation holder
SPC updated Puregon Cartridge
Active Ingredients: Follitropin beta
Company: Organon Laboratories Limited | Document History
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
SPC updated Puregon Solution
Active Ingredients: Follitropin beta
Company: Organon Laboratories Limited | Document History
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
SPC new Victrelis 200 mg hard capsules
Active Ingredients: Boceprevir
Company: Merck Sharp & Dohme Ireland (Human Health) Limited
  • New SPC for new product
SPC updated Xalacom eye drops, solution
Active Ingredients: Latanoprost, Timolol Maleate
Company: Pfizer Healthcare Ireland | 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
  • Change to section 6.4 - Special precautions for storage
PIL updated Xalacom Eye Drops, Solution
Active Ingredients: Latanoprost, Timolol Maleate
Company: Pfizer Healthcare Ireland | Document History
  • Correction of spelling/typing errors
SPC updated Zismirt orotab 15mg, 30mg & 45mg Orodispersible Tablets
Active Ingredients: Mirtazapine
Company: Gerard Laboratories | Document History
  • Change to section 4.2 - Posology and method of administration
  • 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 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
SPC updated Zoely 2.5 mg/1.5 mg film-coated tablets
Active Ingredients: Estradiol Hemihydrate, Nomegestrol Acetate
Company: Merck Sharp & Dohme Ireland (Human Health) Limited | Document History
  • Change to section 10 - Date of revision of the text
25 January 2012
New 1, Updated 13, Retired 2, [Total 16]
PIL retired Amlodipine Pfizer 5 mg and 10 mg Tablets
Active Ingredients: Amlodipine besilate
Company: Pfizer Healthcare Ireland
  • PIL Submitted in error
SPC retired Amlodipine Pfizer 5 mg and 10 mg Tablets
Active Ingredients: Amlodipine besilate
Company: Pfizer Healthcare Ireland
  • SPC submitted in error
SPC updated Decapeptyl (triptorelin) 3-month
Active Ingredients: triptorelin pamoate
Company: Ipsen Pharmaceuticals Ltd | Document History
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic properties
PIL updated Decapeptyl (triptorelin) SR
Active Ingredients: triptorelin acetate
Company: Ipsen Pharmaceuticals Ltd | Document History
  • Improved electronic presentation
SPC updated Decapeptyl (triptorelin) SR
Active Ingredients: triptorelin acetate
Company: Ipsen Pharmaceuticals 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
SPC updated Desmotabs Melt 120 micrograms oral lyophilisate
Active Ingredients: Desmopressin Acetate
Company: Ferring Ireland Limited | Document History
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
SPC updated Desmotabs Melt 240 micrograms, oral lyophilisate
Active Ingredients: Desmopressin Acetate
Company: Ferring Ireland Limited | Document History
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
PIL updated Effentora 100, 200, 400, 600 and 800 micrograms buccal tablets
Active Ingredients: fentanyl citrate
Company: Cephalon Pharma (Ireland) Ltd | Document History
  • Change to side-effects
PIL updated Puregon Cartridge 300IU
Active Ingredients: Follitropin beta
Company: Organon Laboratories Limited | Document History
  • Change to date of revision
  • Change to MA holder contact details
PIL updated Puregon Cartridge 600IU
Active Ingredients: Follitropin beta
Company: Organon Laboratories Limited | Document History
  • Change to date of revision
  • Change to MA holder contact details
PIL updated Puregon Cartridge 900IU
Active Ingredients: Follitropin beta
Company: Organon Laboratories Limited | Document History
  • Change to date of revision
  • Change to MA holder contact details
PIL updated Puregon Solution 100 IU
Active Ingredients: Follitropin beta
Company: Organon Laboratories Limited | Document History
  • Change to MA holder contact details
PIL updated Puregon Solution 50 IU
Active Ingredients: Follitropin beta
Company: Organon Laboratories Limited | Document History
  • Change to date of revision
  • Change to MA holder contact details
PIL new Victrelis 200 mg hard capsules
Active Ingredients: Boceprevir
Company: Merck Sharp & Dohme Ireland (Human Health) Limited
  • New PIL for new product
SPC updated XGEVA
Active Ingredients: Denosumab
Company: Amgen Ltd | Document History
  • Change to section 6.5 - Nature and contents of container
SPC updated Zevalin
Active Ingredients: ibritumomab tiuxetan
Company: Bayer Limited | Document History
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
  • Change to section 12 - Instructions for preparation of radiopharmaceuticals