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Active Ingredients / Generics:
nefopam hydrochloride
- 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
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Active Ingredients / Generics:
apomorphine hydrochloride
- Change to section 7 - Marketing Authorisation Holder
- Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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Active Ingredients / Generics:
ibandronic sodium monohydrate
- 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 5.2 - Pharmacokinetic Properties
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Active Ingredients / Generics:
agalsidase beta
- Change to section 5.1 - Pharmacodynamic Properties
- Change to section 10 date of revision of the text
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Active Ingredients / Generics:
agalsidase beta
- Change to section 5.1 - Pharmacodynamic Properties
- Change to section 10 date of revision of the text
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Active Ingredients / Generics:
diclofenac sodium
- Improved Electronic Presentation
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Active Ingredients / Generics:
vinflunine ditartrate
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Active Ingredients / Generics:
gadopentetic acid (dimeglumine salt)
- Change to section 5.3 - Preclinical Safety Data
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Active Ingredients / Generics:
xylometazoline hydrochloride
- Change to section 5.1 - Pharmacodynamic Properties
- Change to section 10 date of revision of the text
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Active Ingredients / Generics:
xylometazoline hydrochloride
- Change to section 5.1 - Pharmacodynamic Properties
- Change to section 10 date of revision of the text
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Active Ingredients / Generics:
lenalidomide
- Change to information for healthcare professionals
- Change to warnings or special precautions for use
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Active Ingredients / Generics:
potassium chloride
- 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 5.1 - Pharmacodynamic Properties
- Change to section 5.3 - Preclinical Safety Data
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Active Ingredients / Generics:
fosamprenavir calcium
- Change to date of revision
- Change to warnings or special precautions for use
- Change to side-effects
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Active Ingredients / Generics:
didanosine
- Change due to harmonisation of SPC
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Active Ingredients / Generics:
budesonide
- Change to Further Information section
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Active Ingredients / Generics:
trastuzumab
- 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 5.1 - Pharmacodynamic Properties
- Change to section 5.2 - Pharmacokinetic Properties
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Active Ingredients / Generics:
theophylline
- Change to MA holder contact details
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Active Ingredients / Generics:
ethinylestradiol, etonogestrel
- Improved Electronic Presentation
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Active Ingredients / Generics:
pimozide
- Change to date of revision
- Change to warnings or special precautions for use
- Change to side-effects
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Active Ingredients / Generics:
xylometazoline hydrochloride
- Change to section 5.1 - Pharmacodynamic Properties
- Change to section 10 date of revision of the text
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Active Ingredients / Generics:
xylometazoline hydrochloride
- Change to section 5.1 - Pharmacodynamic Properties
- Change to section 10 date of revision of the text
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Active Ingredients / Generics:
fosphenytoin sodium
- Change to appearance of the medicine
- Change to Further Information section
- Change to date of revision, Correction of spelling/typing errors
- Change to warnings or special precautions for use
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Active Ingredients / Generics:
strontium ranelate
- Change to section 4.8 - Undesirable Effects
- 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:
pivmecillinam hydrochloride
- Change to date of revision
- Change to name of manufacturer
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Active Ingredients / Generics:
paroxetine hydrochloride hemihydrate
- Change of manufacturer
- Change to warnings or special precautions for use
- Change to side-effects
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Active Ingredients / Generics:
verapamil hydrochloride
- Change to warnings or special precautions for use
- Change to side-effects
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Active Ingredients / Generics:
nelfinavir mesilate
- Change to section 4.2 - Posology and method of administration
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.2 - Pharmacokinetic Properties
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Alli 60mg hard capsules
Active Ingredients / Generics:
orlistat
- PIL Retired pending re-submission
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Active Ingredients / Generics:
apomorphine hydrochloride
- Change to section 7 - Marketing Authorisation Holder
- Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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Active Ingredients / Generics:
apomorphine hydrochloride
- Change to section 7 - Marketing Authorisation Holder
- Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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Active Ingredients / Generics:
capsaicin
- Change to section 4.8 - Undesirable Effects
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Active Ingredients / Generics:
hyoscine butylbromide
|
Active Ingredients / Generics:
cisplatin
- Change to information for healthcare professionals
- Change to date of revision
- Change to warnings or special precautions for use
|
Active Ingredients / Generics:
potassium clavulanate, amoxicillin sodium
- 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
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Active Ingredients / Generics:
potassium clavulanate, amoxicillin sodium
- 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
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Active Ingredients / Generics:
hydrochlorothiazide, irbesartan
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Active Ingredients / Generics:
hydrochlorothiazide, irbesartan
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Active Ingredients / Generics:
hydrochlorothiazide, irbesartan
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Active Ingredients / Generics:
macrogol 4000
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Active Ingredients / Generics:
fentanyl citrate
- Change to section 6. 3 - Shelf Life
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Active Ingredients / Generics:
ethosuximide
- Change to section 6.2 - Incompatibilities
- Change to section 10 date of revision of the text
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Active Ingredients / Generics:
ethosuximide
- Change to section 6.2 - Incompatibilities
- Change to section 10 date of revision of the text
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Active Ingredients / Generics:
diclofenac sodium
- Improved Electronic Presentation
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Active Ingredients / Generics:
heparin sodium
- Change to date of revision
- Changes to therapeutic indications
|
Active Ingredients / Generics:
human insulin
- Change due to harmonisation of PIL.
- Change to date of revision
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Active Ingredients / Generics:
human insulin
- Change due to harmonisation of PIL.
- Change to date of revision
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Active Ingredients / Generics:
fosaprepitant dimeglumine
- Change to section 4.8 - Undesirable Effects
- Change to section 5.1 - Pharmacodynamic Properties
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Active Ingredients / Generics:
fosaprepitant dimeglumine
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Active Ingredients / Generics:
triamcinolone acetonide
- Change to date of revision
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Active Ingredients / Generics:
omeprazole
- Improved Electronic Presentation
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Active Ingredients / Generics:
naltrexone hydrochloride
- Change to packaging
- Change to date of revision
- Change to storage instructions
|
Active Ingredients / Generics:
pegfilgrastim
- Change to date of revision
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Active Ingredients / Generics:
ethinylestradiol, levonorgestrel
- Change of trade or generic name
- Change to date of revision
|
Active Ingredients / Generics:
testosterone undecanoate
- Improved Electronic Presentation
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Active Ingredients / Generics:
methylphenidate 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
- Change to section 5.1 - Pharmacodynamic Properties
- Change to section 5.3 - Preclinical Safety Data
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Active Ingredients / Generics:
tafluprost
- Change to section 6. 3 - Shelf Life
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Active Ingredients / Generics:
paroxetine hydrochloride hemihydrate
- Change to warnings or special precautions for use
- Change to side-effects
|
Strong Co-danthramer capsules
Active Ingredients / Generics:
poloxamer 188, dantron
|
Active Ingredients / Generics:
testosterone
- Improved Electronic Presentation
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Active Ingredients / Generics:
bosentan monohydrate
- Change to section 4.8 - Undesirable Effects
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Active Ingredients / Generics:
bosentan monohydrate
- Change to section 4.8 - Undesirable Effects
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Active Ingredients / Generics:
didanosine
- Change due to harmonisation of SPC
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