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Active Ingredients / Generics:
aciclovir
- 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:
fluticasone propionate
- Change to dosage and administration
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Active Ingredients / Generics:
potassium chloride, sodium chloride, sodium bicarbonate, macrogol 3350
- Change to side-effects
- Change to drug interactions
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Active Ingredients / Generics:
ipratropium bromide monohydrate
- Change/addition of instructions for reconstitution and/ or administration
- Change to date of revision
- Change of manufacturer
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Active Ingredients / Generics:
hexyl nicotinate, ethyl nicotinate, tetrahydrofurfuryl salicylate
- 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:
ibuprofen lysine
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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Buccastem
Active Ingredients / Generics:
prochlorperazine maleate
- Transfer of Marketing Authorisation Holder
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Active Ingredients / Generics:
ketoconazole
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Active Ingredients / Generics:
olsalazine sodium
- Change to section 4.8 - Undesirable Effects
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Active Ingredients / Generics:
mometasone furoate
- Change to section 4.8 - Undesirable Effects
- Change to separate SPCs covering individual presentations
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Active Ingredients / Generics:
mometasone furoate
- Change to section 4.8 - Undesirable Effects
- Change to separate SPCs covering individual presentations
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Active Ingredients / Generics:
omeprazole sodium
- Correction of spelling/typing errors
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Active Ingredients / Generics:
human insulin
- 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:
potassium chloride, sodium chloride, sodium bicarbonate, macrogol 3350
- Change to section 2 - Qualitative and quantitative composition
- 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 6.2 - Incompatibilities
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Active Ingredients / Generics:
gabapentin
- Change to section 4.8 - Undesirable Effects
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Active Ingredients / Generics:
tegafur, uracil
- Change to section 4.6 - Pregnancy and Lactation
- Change to section 4.8 - Undesirable Effects
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Active Ingredients / Generics:
amphotericin b
- Change to warnings or special precautions for use
- Change to instructions about overdose
- Change to side-effects
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to information about driving or using machinery
- Change to dosage and administration
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Active Ingredients / Generics:
benperidol
- Change to warnings or special precautions for use
- Change to side-effects
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Active Ingredients / Generics:
lorazepam
- Change to date of revision
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Active Ingredients / Generics:
ipratropium bromide monohydrate
- Change/addition of instructions for reconstitution and/ or administration
- Change to date of revision
- Change of manufacturer
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Active Ingredients / Generics:
ibuprofen
- 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:
bisacodyl
- Change to section 4.4 - Special warnings and precautions for Use
- Change to section 4.6 - Pregnancy and Lactation
- 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:
bisacodyl
- Change to section 4.4 - Special warnings and precautions for Use
- Change to section 4.6 - Pregnancy and Lactation
- 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:
bisacodyl
- Change to section 4.4 - Special warnings and precautions for Use
- Change to section 4.6 - Pregnancy and Lactation
- 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:
bisacodyl
- Change to section 4.4 - Special warnings and precautions for Use
- Change to section 4.6 - Pregnancy and Lactation
- 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:
salbutamol sulphate
- Change to section 4.4 - Special warnings and precautions for Use
- Change to section 4.8 - Undesirable Effects
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Active Ingredients / Generics:
salbutamol sulphate
- 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:
perphenazine
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
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Isomel SR 60mg Prolonged-Release Tablets
Active Ingredients / Generics:
isosorbide mononitrate
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Active Ingredients / Generics:
potassium chloride, sodium chloride, sodium bicarbonate, macrogol 3350, sodium sulfate, anhydrous
- Change of contra-indications
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Active Ingredients / Generics:
levothyroxine 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:
methotrexate
- Change to section 3 - Pharmaceutical form
- Change to section 6. 3 - Shelf Life
- Change to section 10 date of revision of the text
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Active Ingredients / Generics:
methotrexate
- Change to section 6. 3 - Shelf Life
- Change to section 10 date of revision of the text
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Active Ingredients / Generics:
potassium chloride, sodium chloride, sodium hydrogen carbonate, macrogol 3350
- Change to side-effects
- Change to drug interactions
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Active Ingredients / Generics:
ketoconazole
- 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
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Active Ingredients / Generics:
citric acid, anhydrous, magnesium oxide light, sodium picosulfate
- 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 first Authorisation/renewal of the Authorisation
- Change to section 10 date of revision of the text
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Active Ingredients / Generics:
mefenamic acid
- Change to section 4.4 - Special warnings and precautions for Use
- Change to section 5.2 - Pharmacokinetic Properties
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Active Ingredients / Generics:
mefenamic acid
- Change to section 4.4 - Special warnings and precautions for Use
- Change to section 5.2 - Pharmacokinetic Properties
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Active Ingredients / Generics:
rabies vaccine
- Change to section 1 -Name of the Medicinal product
- Change to section 6.2 - Incompatibilities
- Change to section 10 date of revision of the text
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Active Ingredients / Generics:
hydrocortisone, dimeticone, benzalkonium chloride, nystatin
- Change to name of manufacturer
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