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Latest medicine updates

74 updates found

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MEDICINE NAME

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STATUS

Pil
Amlodipine 5mg & 10mg Tablets
amlodipine maleate
Retired 21-Aug-17
Concordia International- formerly Focus Pharmaceuticals Ltd
Retired
  • Product/presentation currently not marketed
SPC
Amlodipine 10mg tablets
amlodipine maleate
Retired 21-Aug-17
Concordia International- formerly Focus Pharmaceuticals Ltd
Retired
  • Product/presentation currently not marketed
Pil
Fentazin 2mg and 4mg tablets
perphenazine
Retired 21-Aug-17
Concordia International - formerly AMCo
Retired
  • Product/presentation currently not marketed
SPC
Fentazin 4mg Tablets
perphenazine
Retired 21-Aug-17
Concordia International - formerly AMCo
Retired
  • Product/presentation currently not marketed
Pil
Viskaldix Tablets
pindolol, clopamide
Retired 21-Aug-17
Concordia International - formerly AMCo
Retired
  • Product/presentation currently not marketed
SPC
Viskaldix Tablets
pindolol, clopamide
Retired 21-Aug-17
Concordia International - formerly AMCo
Retired
  • Product/presentation currently not marketed
SPC
zoledronic acid monohydrate
Updated 21-Aug-17
Updated
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.4 - Special warnings and precautions for use
Pil
zoledronic acid monohydrate
Updated 21-Aug-17
Updated
  • Change to section 4 - possible side effects
  • Change to section 4 - possible side effects
  • Change to section 4 - possible side effects
  • Change to section 4 - possible side effects
Pil
paracetamol, codeine phosphate
Updated 21-Aug-17
Updated
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision
SPC
pancreatin
Updated 21-Aug-17
Updated
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
SPC
hydrogen peroxide
Updated 21-Aug-17
Updated
  • Change to section 6.3 - Shelf life
SPC
Ranitidine 300 mg Effervescent Tablets
ranitidine hydrochloride
Retired 18-Aug-17
Accord Healthcare Limited
Retired
  • Product/presentation currently not marketed
SPC
Ranitidine 150 mg Effervescent Tablets
ranitidine hydrochloride
Retired 18-Aug-17
Accord Healthcare Limited
Retired
  • Product/presentation currently not marketed
SPC
baricitinib
Updated 18-Aug-17
Updated
  • Change to section 1 - Name of the medicinal product
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects - how to report a side effect
SPC
Intelence 200mg tablets
etravirine
Retired 18-Aug-17
Janssen-Cilag Ltd
Retired
  • Joint SPC superseded by individual SPCs
SPC
Intelence 25mg tablets
etravirine
Retired 18-Aug-17
Janssen-Cilag Ltd
Retired
  • Joint SPC superseded by individual SPCs
SPC
bedaquiline fumarate
Updated 18-Aug-17
Updated
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text
SPC
rilpivirine hydrochloride
Updated 18-Aug-17
Updated
  • 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
simeprevir sodium
Updated 18-Aug-17
Updated
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
SPC
etravirine
Updated 18-Aug-17
Updated
  • Change to section 1 - Name of the medicinal product
  • 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 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text
SPC
betaxolol hydrochloride
Updated 18-Aug-17
Updated
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
SPC
dequalinium chloride
Updated 18-Aug-17
Updated
  • 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 4.6 - Fertility, 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
SPC
light magnesium oxide, citric acid, anhydrous, sodium picosulfate
Updated 18-Aug-17
Updated
  • Change to section 4.2 - Posology and method of administration
SPC
varicella-zoster virus (live)
Updated 18-Aug-17
Updated
  • Change to section 5.1 - Pharmacodynamic properties
SPC
simvastatin
Updated 18-Aug-17
Updated
  • 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 - Fertility, 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
SPC
sildenafil citrate
Updated 18-Aug-17
Updated
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
SPC
clopidogrel bisulfate
Updated 18-Aug-17
Updated
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
SPC
simvastatin
Updated 18-Aug-17
Updated
  • 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 - Fertility, 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
SPC
simvastatin
Updated 18-Aug-17
Updated
  • 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 - Fertility, 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
SPC
sildenafil citrate
Updated 18-Aug-17
Updated
  • 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 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
SPC
pantoprazole sodium sesquihydrate
Updated 18-Aug-17
Updated
  • 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 - Fertility, 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text
SPC
pantoprazole sodium sesquihydrate
Updated 18-Aug-17
Updated
  • 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 - Fertility, 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text
SPC
phenytoin sodium
Updated 18-Aug-17
Updated
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects - how to report a side effect
SPC
methocarbamol
Updated 18-Aug-17
Updated
  • 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 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 6.1 - List of excipients
  • 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
  • Change to section 4.8 - Undesirable effects - how to report a side effect
Pil
esomeprazole magnesium trihydrate
Updated 18-Aug-17
Updated
  • Previous version of PIL reinstated
Pil
Daptomycin 500 mg powder for solution for injection/infusion
Retired 18-Aug-17
Accord Healthcare Limited
Retired
  • Product/presentation currently not marketed
SPC
asparaginase
Updated 18-Aug-17
Updated
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
SPC
pertuzumab
Updated 18-Aug-17
Updated
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
SPC
pregabalin
Updated 18-Aug-17
New
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
SPC
enalapril maleate
Updated 18-Aug-17
Updated
  • Change to section 3 - Pharmaceutical form
SPC
pregabalin
Updated 18-Aug-17
New
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
SPC
pregabalin
Updated 18-Aug-17
New
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
SPC
pregabalin
Updated 18-Aug-17
New
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
Pil
empagliflozin
Updated 17-Aug-17
Updated
  • Improved presentation of PIL
Pil
metformin hydrochloride, empagliflozin
Updated 17-Aug-17
Updated
  • Improved presentation of PIL
Pil
rituximab
Updated 17-Aug-17
Updated
  • Change to section 6 - date of revision
Pil
cytarabine
Updated 17-Aug-17
Updated
  • Change to section 6 - manufacturer
SPC
estradiol valerate
Updated 17-Aug-17
Updated
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
SPC
estradiol valerate
Updated 17-Aug-17
Updated
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
SPC
tramadol hydrochloride
Updated 17-Aug-17
Updated
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

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