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Active Ingredients / Generics:
alendronate sodium trihydrate
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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Active Ingredients / Generics:
candesartan cilexetil
- Change due to user-testing of patient information
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Active Ingredients / Generics:
amiodarone hydrochloride
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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Active Ingredients / Generics:
amiodarone hydrochloride
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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Active Ingredients / Generics:
aspirin, dipyridamole
- Change to section 4.4 - Special warnings and precautions for Use
- Change to section 4.8 - Undesirable Effects
- Change to section 10 date of revision of the text
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Active Ingredients / Generics:
chloramphenicol
- Change to section 6.1 - List of Excipients
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Active Ingredients / Generics:
bicalutamide
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Active Ingredients / Generics:
citalopram hydrochloride
- Change/addition of instructions for reconstitution and/ or administration
- Change to side-effects
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Active Ingredients / Generics:
citalopram hydrobromide
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Active Ingredients / Generics:
enoxaparin sodium
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
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Active Ingredients / Generics:
furosemide, amiloride hydrochloride anhydrous
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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Active Ingredients / Generics:
paracetamol, codeine phosphate hemihydrate
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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Active Ingredients / Generics:
trimethoprim, sulfamethoxazole
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Active Ingredients / Generics:
methylprednisolone acetate
- Change to side-effects
- Change due to user-testing of patient information
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Active Ingredients / Generics:
lidocaine hydrochloride, methylprednisolone acetate
- Change to side-effects
- Change due to user-testing of patient information
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Active Ingredients / Generics:
diclofenac sodium
- Change to date of revision
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Active Ingredients / Generics:
oxybutynin hydrochloride
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Active Ingredients / Generics:
ethinylestradiol, gestodene
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6. 6 - Instructions for use, handling and disposal
- Change to section 10 date of revision of the text
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Active Ingredients / Generics:
ethinylestradiol, gestodene
- Change due to user-testing of patient information
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Active Ingredients / Generics:
ethinylestradiol, gestodene
- Change due to user-testing of patient information
|
Active Ingredients / Generics:
gabapentin
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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Active Ingredients / Generics:
gabapentin
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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Active Ingredients / Generics:
insulin glargine
- Change due to harmonisation of PIL.
- Change due to user-testing of patient information
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Active Ingredients / Generics:
ethinylestradiol, levonorgestrel
- Change due to user-testing of patient information
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Active Ingredients / Generics:
ethinylestradiol, levonorgestrel
- Change due to user-testing of patient information
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Active Ingredients / Generics:
ethinylestradiol, levonorgestrel
- Change due to user-testing of patient information
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Active Ingredients / Generics:
paracetamol
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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Active Ingredients / Generics:
paracetamol, sodium hydrogen carbonate
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
ramipril
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
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Active Ingredients / Generics:
ethinylestradiol, gestodene
- Change due to user-testing of patient information
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Active Ingredients / Generics:
venlafaxine hydrochloride
- Improved Electronic Presentation
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Active Ingredients / Generics:
simvastatin
- Change to section 4.4 - Special warnings and precautions for Use
- Change to section 4.8 - Undesirable Effects
- Change to section 10 date of revision of the text
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Active Ingredients / Generics:
alendronate sodium trihydrate
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
amiodarone hydrochloride
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
misoprostol, diclofenac sodium
- Change to date of revision, Correction of spelling/typing errors
- Change to dosage and administration
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Active Ingredients / Generics:
nelarabine
- Change to Further Information section
- Change to side-effects
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Active Ingredients / Generics:
chloramphenicol
- Change to drug interactions
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Active Ingredients / Generics:
diltiazem hydrochloride
- Change due to user-testing of patient information
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Active Ingredients / Generics:
diltiazem hydrochloride
- Change due to user-testing of patient information
|
Active Ingredients / Generics:
doxorubicin hydrochloride
- Change to section 4.2 - Posology and method of administration
|
Active Ingredients / Generics:
doxorubicin hydrochloride
- Change to section 4.2 - Posology and method of administration
|
Active Ingredients / Generics:
prasugrel hydrochloride
- 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 8 - MARKETING AUTHORISATION NUMBER(S)
- Change to section 10 date of revision of the text
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Active Ingredients / Generics:
flupentixol dihydrochloride
- Change to section 4.2 - Posology and method of administration
- Change to section 10 date of revision of the text
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Active Ingredients / Generics:
glyceryl trinitrate
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
indapamide hemihydrate
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
tinzaparin sodium
- Change to date of revision
- Change to side-effects
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Active Ingredients / Generics:
tinzaparin sodium
- Change to date of revision
- Change to side-effects
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Active Ingredients / Generics:
tinzaparin sodium
- Change to date of revision
- Change to side-effects
|
Active Ingredients / Generics:
tinzaparin sodium
- Change to date of revision
- Change to side-effects
|
Active Ingredients / Generics:
ketoprofen
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
ketoprofen
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
loprazolam mesilate
- Change to section 6. 3 - Shelf Life
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
sertraline hydrochloride
- 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
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Active Ingredients / Generics:
omeprazole
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
oxaliplatin
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
paracetamol
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
paracetamol
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
bexarotene
- Change to section 7 - Marketing Authorisation Holder
|
Active Ingredients / Generics:
topiramate
|
Active Ingredients / Generics:
topiramate
|
Active Ingredients / Generics:
topiramate
|
Active Ingredients / Generics:
goserelin acetate
- 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 10 date of revision of the text
|
Active Ingredients / Generics:
goserelin acetate
- 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 10 date of revision of the text
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Active Ingredients / Generics:
soya oil
- Change to section 6. 5 - Nature and Contents of Container
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
bendroflumethiazide
- Change due to user-testing of patient information
|
Active Ingredients / Generics:
paracetamol, codeine phosphate
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
ganciclovir
- Change due to user-testing of patient information
|
Active Ingredients / Generics:
hydrocortisone acetate, miconazole nitrate
|
Active Ingredients / Generics:
flecainide acetate
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
human normal immunoglobulin
|
Active Ingredients / Generics:
insulin lispro
- Change to section 1 -Name of the Medicinal product
- 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 - Instructions for use, handling and disposal
- Change to section 10 date of revision of the text, Introduction of new pack/pack size
|
Active Ingredients / Generics:
calcium levofolinate
- Change to Further Information section
- Change to date of revision
- Change to warnings or special precautions for use
- Change to drug interactions
- Change due to user-testing of patient information
|
Active Ingredients / Generics:
multivitamins
- Change due to user-testing of patient information
|
Active Ingredients / Generics:
pseudoephedrine hydrochloride, triprolidine hydrochloride
- Change to section 6. 4 - Special Precautions for Storage
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
esomeprazole magnesium trihydrate
- Change to warnings or special precautions for use
- Change to drug interactions
- Change to manufacturer contact details
|
Active Ingredients / Generics:
sodium valproate
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
oseltamivir phosphate
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable Effects
- Change to section 5.2 - Pharmacokinetic Properties
- Change to section 6. 4 - Special Precautions for Storage
|
Active Ingredients / Generics:
thalidomide
- Change to section 1 -Name of the Medicinal product
|
Active Ingredients / Generics:
topiramate
|
Active Ingredients / Generics:
paracetamol, codeine phosphate, caffeine
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
venlafaxine hydrochloride
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
venlafaxine hydrochloride
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
lacosamide
- Change to section 6. 5 - Nature and Contents of Container
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