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Active Ingredients / Generics:
tacrolimus monohydrate
- Introduction of new strength
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Active Ingredients / Generics:
almotriptan D, L-hydrogen malate
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
bivalirudin
- Change to section 4.8 - Undesirable Effects
- Change due to harmonisation of SPC
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Active Ingredients / Generics:
benperidol
- 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 side-effects
- Change to drug interactions
- Change due to user-testing of patient information
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Active Ingredients / Generics:
bambuterol hydrochloride
- Change to warnings or special precautions for use
- Change to side-effects
|
Active Ingredients / Generics:
hexylresorcinol
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
hexylresorcinol
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
hexylresorcinol
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Cipralex 5, 10 and 20 mg Film-Coated Tablets and 10 mg/ml oral drops, solution.
Active Ingredients / Generics:
escitalopram
- SPC Retired pending re-submission
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Active Ingredients / Generics:
escitalopram oxalate
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Active Ingredients / Generics:
norgestrel, estradiol valerate
- Change to name of manufacturer
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DYNEPO
Active Ingredients / Generics:
epoetin delta
- SPC Product / presentation discontinued
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DYNEPO
Active Ingredients / Generics:
epoetin delta
- PIL Product / presentation discontinued
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Active Ingredients / Generics:
budesonide
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic Properties
- Change to section 5.3 - Preclinical Safety Data
- Change to section 10 date of revision of the text
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Active Ingredients / Generics:
budesonide
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic Properties
- Change to section 5.3 - Preclinical Safety Data
- Change to section 10 date of revision of the text
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Active Ingredients / Generics:
budesonide
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic Properties
- Change to section 5.3 - Preclinical Safety Data
- Change to section 10 date of revision of the text
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Active Ingredients / Generics:
teriparatide
- Addition of separate PILs covering individual presentations
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Active Ingredients / Generics:
teriparatide
- Addition of separate PILs covering individual presentations
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Gyno-Daktarin 100 mg pessaries
Active Ingredients / Generics:
miconazole nitrate
- PIL Product / presentation discontinued
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Gyno-Daktarin 100mg pessaries
Active Ingredients / Generics:
miconazole nitrate
- SPC Product / presentation discontinued
|
Active Ingredients / Generics:
pseudoephedrine 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 4.8 - Undesirable Effects
|
Active Ingredients / Generics:
abatacept
- Change to section 4.4 - Special warnings and precautions for Use
- Change to section 4.8 - Undesirable Effects
- Change to section 6. 3 - Shelf Life
- Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
cetirizine hydrochloride
- Change due to harmonisation of PIL.
|
Active Ingredients / Generics:
cetirizine hydrochloride
- Change due to harmonisation of PIL.
|
Active Ingredients / Generics:
aceclofenac
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
minoxidil
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
paracetamol, dihydrocodeine tartrate
- Change to section 10 date of revision of the text
|
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Active Ingredients / Generics:
valproate semisodium
- Change to section 9 - Date of first Authorisation/renewal of the Authorisation
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
liquid paraffin, benzalkonium chloride, isopropyl myristate, chlorhexidine dihydrochloride
- Change due to user-testing of patient information
|
Evorel Pak
Active Ingredients / Generics:
norethisterone, estradiol
- PIL Product / presentation discontinued
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Active Ingredients / Generics:
influenza vaccine
- Change due to harmonisation of PIL.
|
Ortho-creme Contraceptive Cream
Active Ingredients / Generics:
nonoxinol-9
- PIL Product / presentation discontinued
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Ortho-Creme Contraceptive Cream
Active Ingredients / Generics:
nonoxinol-9
- SPC Product / presentation discontinued
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Orthoforms Contraceptive Pessaries
Active Ingredients / Generics:
nonoxinol-9
- SPC Product / presentation discontinued
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OrthoformsContraceptive Pessaries
Active Ingredients / Generics:
nonoxinol-9
- PIL Product / presentation discontinued
|
Active Ingredients / Generics:
darunavir ethanolate
- Change to date of revision
- Change to, or new, use for medicine
- Change to warnings or special precautions for use
- Change to side-effects
- Change to dosage and administration
|
Active Ingredients / Generics:
darunavir ethanolate
- Change to date of revision
- Change to, or new, use for medicine
- Change to warnings or special precautions for use
- Change to side-effects
- Change to dosage and administration
|
Active Ingredients / Generics:
moroctocog alfa
- Change to section 9 - Date of first Authorisation/renewal of the Authorisation
|
Regurin 20mg Tablets
Active Ingredients / Generics:
trospium chloride
- Change of distributor for the product
|
Regurin 20mg Tablets
Active Ingredients / Generics:
trospium chloride
- Change of distributor for the product
|
Active Ingredients / Generics:
rifampicin
- Change to section 5.2 - Pharmacokinetic Properties
|
Active Ingredients / Generics:
isoniazid, rifampicin, pyrazinamide
- Change to section 5.2 - Pharmacokinetic Properties
|
Active Ingredients / Generics:
isoniazid, rifampicin
- Change to section 5.2 - Pharmacokinetic Properties
|
Active Ingredients / Generics:
oxcarbazepine
- 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 5.2 - Pharmacokinetic Properties
|
Active Ingredients / Generics:
histrelin acetate
|
Active Ingredients / Generics:
idarubicin hydrochloride
- Change to section 4.4 - Special warnings and precautions for Use
|
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Active Ingredients / Generics:
salicylic acid, lactic acid
- Improved Electronic Presentation
|
Active Ingredients / Generics:
hexylresorcinol
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
nandrolone decanoate
- Change due to user-testing of patient information
|
Active Ingredients / Generics:
white soft paraffin
- Change to section 4.4 - Special warnings and precautions for Use
|
Active Ingredients / Generics:
liquid paraffin, isopropyl myristate
- Change to storage instructions
|
Active Ingredients / Generics:
prasugrel hydrochloride
- Change to section 5.1 - Pharmacodynamic Properties
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
sodium valproate
- Change to name of manufacturer
|
Active Ingredients / Generics:
adrenaline
- Change to date of revision
|
Active Ingredients / Generics:
adrenaline
- Change to date of revision
|
Exubera
Active Ingredients / Generics:
human insulin
- SPC Product / presentation discontinued
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Exubera
Active Ingredients / Generics:
human insulin
- PIL Product / presentation discontinued
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Farlutal 100, 250 & 500 Tablets
Active Ingredients / Generics:
medroxyprogesterone acetate
- PIL Product / presentation discontinued
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Farlutal 100,250,500
Active Ingredients / Generics:
medroxyprogesterone acetate
- SPC Product / presentation discontinued
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