| |
Active Ingredients / Generics:
human albumin
|
Active Ingredients / Generics:
human albumin
|
Active Ingredients / Generics:
atenolol
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
salbutamol sulphate
- Change to section 4.9 - Overdose
|
Active Ingredients / Generics:
salbutamol sulphate
- Change to section 4.9 - Overdose
|
Active Ingredients / Generics:
sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate
- 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 4.7 - Effects on Ability to Drive and Use Machines
- Change to section 4.8 - Undesirable Effects
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
irinotecan hydrochloride trihydrate
- Change to Further Information section
- Change to date of revision, Correction of spelling/typing errors
- Change to, or new, use for medicine
- Change to warnings or special precautions for use
- Change of contra-indications
- Change to instructions about overdose
- Change to storage instructions
- 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
- Changes to therapeutic indications
|
Konakion Tablets 10mg
Active Ingredients / Generics:
phytomenadione
- PIL Product / presentation discontinued
|
Konakion Tablets 10mg
Active Ingredients / Generics:
phytomenadione
- SPC Product / presentation discontinued
|
Active Ingredients / Generics:
bupivacaine hydrochloride
- Change to warnings or special precautions for use
- Change to storage instructions
- Change to side-effects
|
Active Ingredients / Generics:
metoclopramide hydrochloride
- Change to side-effects
- Change to drug interactions
|
Active Ingredients / Generics:
budesonide
- Change to section 7 - Marketing Authorisation Holder
- Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
- 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:
diphenhydramine hydrochloride
- 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
|
Active Ingredients / Generics:
omeprazole
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
influenza vaccine (split virion, inactivated)
- 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 6. 5 - Nature and Contents of Container
|
Active Ingredients / Generics:
paracetamol, sodium hydrogen carbonate
- Change to section 1 -Name of the Medicinal product
|
Active Ingredients / Generics:
estradiol valerate
- 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
|
Rebif 22 micrograms solution for injection in pre-filled syringe
Active Ingredients / Generics:
interferon beta-1a
- Individual presentations superseded by joint SPC
|
Rebif 22 micrograms/0.5 ml solution for injection in cartridge
Active Ingredients / Generics:
interferon beta-1a
- Individual presentations superseded by joint SPC
|
Rebif 44 micrograms solution for injection in pre-filled syringe
Active Ingredients / Generics:
interferon beta-1a
- Individual presentations superseded by joint SPC
|
Rebif 44 micrograms/0.5ml solution for injection in cartridge
Active Ingredients / Generics:
interferon beta-1a
- Individual presentations superseded by joint SPC
|
Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack
Active Ingredients / Generics:
interferon beta-1a
- Individual presentations superseded by joint SPC
|
Rebif 8.8 micrograms/0.1 ml solution for injection in cartridge and Rebif 22 micrograms/0.25 ml solution for injection in cartridge
Active Ingredients / Generics:
interferon beta-1a
- Individual presentations superseded by joint SPC
|
Active Ingredients / Generics:
interferon beta-1a
- Change to section 6. 4 - Special Precautions for Storage
|
Active Ingredients / Generics:
interferon beta-1a
- Change to section 6. 4 - Special Precautions for Storage
|
Active Ingredients / Generics:
salbutamol sulphate
- Change to section 7 - Marketing Authorisation Holder
- Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
- 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:
levodopa, carbidopa
- Change to section 1 -Name of the Medicinal product
- Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
- Change to section 9 - Date of first Authorisation/renewal of the Authorisation
|
Active Ingredients / Generics:
sodium valproate
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
nifedipine
- Change to MA holder contact details
|
Active Ingredients / Generics:
tranexamic acid
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
lapatinib ditosylate monohydrate
- Change to section 4.8 - Undesirable Effects
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
tegafur, uracil
- Change to section 7 - Marketing Authorisation Holder
|
Active Ingredients / Generics:
ranitidine hydrochloride
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
|
| |
Active Ingredients / Generics:
everolimus
- 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
|
Active Ingredients / Generics:
alimemazine tartrate
- 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 to section 6.2 - Incompatibilities
|
Active Ingredients / Generics:
betaxolol hydrochloride
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
maraviroc
- Change to section 4.4 - Special warnings and precautions for Use
- Change to section 5.1 - Pharmacodynamic Properties
- Change to section 6. 6 - Instructions for use, handling and disposal
|
Active Ingredients / Generics:
ciprofloxacin lactate
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
reboxetine
- Change to section 4.8 - Undesirable Effects
|
Active Ingredients / Generics:
budesonide
- Change to warnings or special precautions for use
- Change to side-effects
|
Active Ingredients / Generics:
budesonide
- Change to warnings or special precautions for use
- Change to side-effects
|
Active Ingredients / Generics:
amiloride hydrochloride, furosemide
- Change to drug interactions
|
Active Ingredients / Generics:
amiloride hydrochloride, furosemide
- Change to drug interactions
|
Active Ingredients / Generics:
acarbose
- Change to section 1 -Name of the Medicinal product
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
acarbose
- Change to section 1 -Name of the Medicinal product
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
eplerenone
- Change to section 2 - Qualitative and quantitative composition
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
irinotecan hydrochloride trihydrate
- 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 - 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 5.2 - 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 - Instructions for use, handling and disposal
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
insulin glargine
- Change due to harmonisation of PIL.
- Change due to user-testing of patient information
|
Active Ingredients / Generics:
lidocaine hydrochloride
- 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 4.8 - Undesirable Effects
- Change to section 4.9 - Overdose
|
Active Ingredients / Generics:
lidocaine hydrochloride
- 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 4.8 - Undesirable Effects
- Change to section 4.9 - Overdose
|
Active Ingredients / Generics:
loteprednol etabonate
- Removal of Black Triangle
|
Active Ingredients / Generics:
methylprednisolone
- Change to section 3 - Pharmaceutical form
|
Active Ingredients / Generics:
metolazone
- Change due to user-testing of patient information
|
Active Ingredients / Generics:
nebivolol hydrochloride
|
Active Ingredients / Generics:
octreotide acetate
- Change to section 1 -Name of the Medicinal product
- 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 6. 3 - Shelf Life
- Change to section 6. 5 - Nature and Contents of Container
- Change to section 7 - Marketing Authorisation Holder
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
octreotide acetate
- Change to section 1 -Name of the Medicinal product
- 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 6. 3 - Shelf Life
- Change to section 6. 5 - Nature and Contents of Container
- Change to section 7 - Marketing Authorisation Holder
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
perindopril erbumine
- Removal/change of distributor
|
Active Ingredients / Generics:
darunavir ethanolate
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.1 - Pharmacodynamic Properties
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
darunavir ethanolate
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.1 - Pharmacodynamic Properties
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
darunavir ethanolate
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.1 - Pharmacodynamic Properties
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
sodium cromoglicate
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
sodium cromoglicate
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
carbamazepine
- 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:
carbamazepine
- 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:
carbamazepine
- 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:
carbamazepine
- 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:
everolimus
- Change to date of revision, Introduction of new pack/pack size
|
Active Ingredients / Generics:
alimemazine tartrate
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
nonacog alfa
- 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
|
Active Ingredients / Generics:
paracetamol, diphenhydramine hydrochloride
- Change to date of revision
- Change to dosage and administration
|
Active Ingredients / Generics:
paracetamol
- Change to date of revision
- Change to side-effects
- Changes to therapeutic indications
|
Active Ingredients / Generics:
paracetamol
- Change to date of revision
- Change to side-effects
- Changes to therapeutic indications
|
Active Ingredients / Generics:
paracetamol
- Change to date of revision
- Change to side-effects
- Changes to therapeutic indications
|
Active Ingredients / Generics:
paracetamol
- Change to date of revision
- Change to side-effects
- Changes to therapeutic indications
|
Active Ingredients / Generics:
dexrazoxane hydrochloride
- Change due to harmonisation of PIL.
- Change due to user-testing of patient information
|
Active Ingredients / Generics:
clopidogrel besilate
|
Active Ingredients / Generics:
gabapentin
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
gabapentin
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
paliperidone
- Change to date of revision
- Change to warnings or special precautions for use
- Change to side-effects
|
Active Ingredients / Generics:
lidocaine hydrochloride
- 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 4.8 - Undesirable Effects
- Change to section 4.9 - Overdose
|
Active Ingredients / Generics:
lidocaine hydrochloride
- 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 4.8 - Undesirable Effects
- Change to section 4.9 - Overdose
|
Active Ingredients / Generics:
alprostadil
- Change to section 6. 3 - Shelf Life
|
Active Ingredients / Generics:
alprostadil
- Change to section 6. 3 - Shelf Life
|
Active Ingredients / Generics:
white soft paraffin, light liquid paraffin
- Change to section 7 - Marketing Authorisation Holder
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
white soft paraffin, light liquid paraffin
- Change to section 7 - Marketing Authorisation Holder
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
strontium ranelate
- Change/addition of instructions for reconstitution and/ or administration
- Change to Further Information section
- Change to date of revision
- Change to warnings or special precautions for use
- Change to storage instructions
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to information about driving or using machinery
|
Active Ingredients / Generics:
sodium valproate
- Change to section 4.9 - Overdose
- Change to section 10 date of revision of the text
|
Sodium Valproate 200mg/5ml Liquid
Active Ingredients / Generics:
sodium valproate
- PIL Retired pending re-submission
|
Active Ingredients / Generics:
trazodone hydrochloride
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
paracetamol, codeine phosphate hemihydrate
- Change to date of revision
- Change to Marketing Authorisation Holder, Company name change or merger
|
Active Ingredients / Generics:
trabectedin
- 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 4.8 - Undesirable Effects
- Change to section 5.1 - Pharmacodynamic Properties
- Change to section 5.2 - Pharmacokinetic Properties
- Change to section 6. 6 - Instructions for use, handling and disposal
- Change to section 10 date of revision of the text
|