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Latest medicine updates

133 updates found

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STATUS

SPC
disodium clodronate tetrahydrate,
Updated 18-Jan-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 4.2 - 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 4.8 - Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
SPC
imatinib mesilate,
Updated 18-Jan-17
New
  • New SPC for new product
SPC
imatinib mesilate,
Updated 18-Jan-17
New
  • New SPC for new product
SPC
hyoscine butylbromide,
Updated 18-Jan-17
Updated
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text
SPC
esomeprazole magnesium amorphous,
Updated 18-Jan-17
New
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
SPC
Valerian extract, Valeriana officinalis
Updated 18-Jan-17
New
  • New SPC for new product
SPC
esomeprazole magnesium amorphous,
Updated 18-Jan-17
New
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
SPC
fluoxetine hydrochloride,
Updated 18-Jan-17
New
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
Pil
asfotase alfa,
Updated 18-Jan-17
Updated
  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
Pil
asfotase alfa,
Updated 18-Jan-17
Updated
  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
Pil
nonacog alfa
Updated 18-Jan-17
Updated
  • Change to section 2 - what you need to know - warnings and precautions
SPC
lansoprazole
Updated 18-Jan-17
Updated
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
Pil
daclatasvir dihydrochloride,
Updated 18-Jan-17
Updated
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision
  • Company name change or merger
SPC
pregabalin
Updated 18-Jan-17
New
  • New SPC for new product
SPC
Vimpat 50 mg, 100 mg, 150 mg & 200 mg film-coated tablets, 10 mg/ml syrup and 10 mg/ml solution for infusion
lacosamide
Retired 18-Jan-17
UCB Pharma Limited
Retired
  • Individual SPC superseded by joint SPC
SPC
pregabalin
Updated 18-Jan-17
New
  • New SPC for new product
SPC
pregabalin
Updated 18-Jan-17
New
  • New SPC for new product
SPC
pregabalin
Updated 18-Jan-17
New
  • New SPC for new product
SPC
pregabalin
Updated 18-Jan-17
New
  • New SPC for new product
SPC
pregabalin
Updated 18-Jan-17
New
  • New SPC for new product
SPC
pregabalin
Updated 18-Jan-17
New
  • New SPC for new product
SPC
pregabalin
Updated 18-Jan-17
New
  • New SPC for new product
SPC
paracetamol
Updated 18-Jan-17
Updated
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
SPC
paracetamol, codeine phosphate
Updated 18-Jan-17
Updated
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
SPC
testosterone undecanoate
Updated 18-Jan-17
Updated
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text
SPC
erythromycin stearate,
Updated 18-Jan-17
Updated
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
SPC
erythromycin stearate,
Updated 18-Jan-17
Updated
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
SPC
erythromycin ethylsuccinate,
Updated 18-Jan-17
Updated
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
SPC
erythromycin ethylsuccinate,
Updated 18-Jan-17
Updated
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
SPC
erythromycin ethylsuccinate,
Updated 18-Jan-17
Updated
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.8 - Undesirable effects - how to report a side effect
SPC
erythromycin ethylsuccinate,
Updated 18-Jan-17
Updated
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
SPC
macitentan,
Updated 18-Jan-17
Updated
  • Change to section 6.3 - Shelf life
Pil
erythromycin ethylsuccinate,
Updated 18-Jan-17
Updated
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
Pil
erythromycin ethylsuccinate,
Updated 18-Jan-17
Updated
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
Pil
erythromycin stearate,
Updated 18-Jan-17
Updated
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
Pil
levetiracetam
Updated 18-Jan-17
Updated
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors
SPC
dasabuvir sodium monohydrate,
Updated 18-Jan-17
Updated
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
SPC
rabeprazole sodium
Updated 18-Jan-17
Updated
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
SPC
tenofovir disoproxil fumarate
Updated 18-Jan-17
Updated
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
SPC
tenofovir disoproxil fumarate
Updated 18-Jan-17
Updated
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
SPC
tenofovir disoproxil fumarate
Updated 18-Jan-17
Updated
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
SPC
budesonide
Updated 18-Jan-17
Updated
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
Pil
ciclosporin, cyclosporin
Updated 18-Jan-17
Updated
  • Change to section 4 - how to report a side effect
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
  • Change to other sources of information section
Pil
sildenafil citrate,
Updated 18-Jan-17
Updated
  • Change to section 6 - what the product looks like and pack contents
Pil
testosterone undecanoate
Updated 18-Jan-17
Updated
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision
Pil
buprenorphine hydrochloride,
Updated 18-Jan-17
New
  • New PIL for new product
SPC
oseltamivir phosphate, tamiflu
Updated 18-Jan-17
Updated
  • Change to section 5.1 - Pharmacodynamic properties
SPC
oseltamivir phosphate, tamiflu
Updated 18-Jan-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 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 8 - Marketing authorisation number(s)
SPC
atropine sulfate, atropine sulphate
Updated 18-Jan-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 4.1 - 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 4.8 - Undesirable effects - how to report a side effect
  • 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 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
SPC
atropine sulfate, atropine sulphate
Updated 18-Jan-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 4.1 - 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 4.8 - Undesirable effects - how to report a side effect
  • 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 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

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