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Latest medicine updates

93 updates found

New New Updated Updated Retired Retired

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MEDICINE NAME

CHANGES

Date range

DOCUMENT TYPE

STATUS

SPC
afatinib dimaleate,
Updated 30-Mar-17
Updated
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
Pil
fludrocortisone acetate
Updated 30-Mar-17
Updated
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision
Pil
olanzapine
Updated 30-Mar-17
Updated
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
Pil
denosumab ,
Updated 30-Mar-17
Updated
  • Change to section 6 - manufacturer
Pil
doxycycline hyclate,
Updated 30-Mar-17
Updated
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision
Pil
paracetamol, caffeine
Updated 30-Mar-17
Updated
  • Change to section 6 - marketing authorisation holder
  • Company name change or merger
Pil
nintedanib esilate,
Updated 30-Mar-17
Updated
  • Improved presentation of PIL
SPC
prednisone,
Updated 30-Mar-17
Updated
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Pil
teicoplanin
Updated 30-Mar-17
Updated
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
Pil
fludrocortisone acetate
Updated 30-Mar-17
Updated
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision
Pil
calcium folinate, calcium leucovorin; leucovorin calcium
Updated 30-Mar-17
Updated
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
SPC
ataluren,
Updated 30-Mar-17
Updated
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
SPC
ataluren,
Updated 30-Mar-17
Updated
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
SPC
insulin glulisine
Updated 30-Mar-17
New
  • New individual SPC (was previously included in joint SPC)
SPC
lacosamide,
Updated 30-Mar-17
Updated
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
SPC
lacosamide,
Updated 30-Mar-17
Updated
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
SPC
human insulin
Updated 30-Mar-17
Updated
  • Change to section 1 - Name of the medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • 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 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
SPC
human insulin
Updated 30-Mar-17
Updated
  • Change to section 1 - Name of the medicinal product
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
SPC
paracetamol, ibuprofen
Updated 30-Mar-17
Updated
  • Change to section 6.5 - Nature and contents of container
SPC
Fludrocortisone acetate 0.1 mg tablets
fludrocortisone acetate
Retired 30-Mar-17
Aspen
Retired
  • Submitted in error
SPC
pancuronium bromide
Updated 30-Mar-17
Updated
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
SPC
influenza vaccine
Updated 30-Mar-17
Updated
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Pil
eculizumab
Updated 29-Mar-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 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
  • Company name change or merger
SPC
omeprazole sodium,
Updated 29-Mar-17
Updated
  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.6 - 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 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
ataluren,
Updated 29-Mar-17
Updated
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
SPC
gliclazide
Updated 29-Mar-17
Updated
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
SPC
teduglutide,
Updated 29-Mar-17
Updated
  • 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
  • Change to section 10 - Date of revision of the text
SPC
lacosamide,
Updated 29-Mar-17
Updated
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
Pil
lacosamide,
Updated 29-Mar-17
Updated
  • Change to section 3 - how to take/use
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Change to other sources of information section
SPC
lacosamide,
Updated 29-Mar-17
Updated
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
SPC
lacosamide,
Updated 29-Mar-17
Updated
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
SPC
lacosamide,
Updated 29-Mar-17
Updated
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
Pil
lacosamide,
Updated 29-Mar-17
Updated
  • Change to section 3 - how to take/use
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Change to other sources of information section
Pil
lacosamide,
Updated 29-Mar-17
Updated
  • Change to section 3 - how to take/use
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Change to other sources of information section
SPC
natalizumab
Updated 29-Mar-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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.5 - Nature and contents of container
SPC
sirolimus
Updated 29-Mar-17
Updated
  • 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 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • 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 8 - Marketing authorisation number(s)
SPC
alprostadil
Updated 29-Mar-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
aripiprazole
Updated 29-Mar-17
Updated
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text
SPC
aripiprazole
Updated 29-Mar-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 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text
SPC
aripiprazole
Updated 29-Mar-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 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text
SPC
flucloxacillin sodium
Updated 29-Mar-17
Updated
  • 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 10 - Date of revision of the text
SPC
flucloxacillin sodium
Updated 29-Mar-17
Updated
  • 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 10 - Date of revision of the text
Pil
influenza vaccine
Updated 29-Mar-17
Updated
  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision
SPC
human urokinase,
Updated 29-Mar-17
Updated
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
Pil
filgrastim
Updated 29-Mar-17
Updated
  • Change to section 6 - manufacturer
SPC
isavuconazole,
Updated 29-Mar-17
Updated
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.6 - Special precautions for disposal and other handling
SPC
isavuconazole,
Updated 29-Mar-17
Updated
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.6 - Special precautions for disposal and other handling
SPC
human urokinase,
Updated 29-Mar-17
Updated
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
Pil
teduglutide,
Updated 29-Mar-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 4 - possible side effects
  • Change to section 6 - date of revision
SPC
linezolid
Updated 29-Mar-17
Updated
  • Change to section 1 - Name of the medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • 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 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 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

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