| |
Active Ingredients / Generics:
amlodipine besilate
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
amlodipine besilate
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
apomorphine hydrochloride
- Change of manufacturer
- Change to manufacturer contact details
|
Active Ingredients / Generics:
quetiapine hemifumarate
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
levonorgestrel
- Change to packaging
- Change to date of revision
|
Active Ingredients / Generics:
paracetamol, codeine phosphate
- Change to packaging
- Change to date of revision
|
Active Ingredients / Generics:
calcium carbonate
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
light liquid paraffin
|
Active Ingredients / Generics:
white soft paraffin, light liquid paraffin
|
Active Ingredients / Generics:
levobupivacaine hydrochloride
- Change to information for healthcare professionals
- Change to side-effects
|
Active Ingredients / Generics:
levobupivacaine hydrochloride
- Change to information for healthcare professionals
- Change to side-effects
|
Active Ingredients / Generics:
levobupivacaine hydrochloride
- Change to information for healthcare professionals
- Change to side-effects
|
Active Ingredients / Generics:
cisplatin
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
citalopram hydrobromide
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
clarithromycin
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
clopidogrel hydrogen sulphate
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
clopidogrel hydrogen sulphate
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
cytarabine
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
clozapine
|
Active Ingredients / Generics:
clozapine
|
Active Ingredients / Generics:
liquid paraffin, benzalkonium chloride, isopropyl myristate, chlorhexidine dihydrochloride
- Change to Further Information section
- Change to date of revision
|
Active Ingredients / Generics:
donepezil hydrochloride monohydrate
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
donepezil hydrochloride monohydrate
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
parecoxib sodium
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.6 - Pregnancy and Lactation
- Change to section 4.8 - Undesirable Effects
- Change to section 6. 3 - Shelf Life
|
Active Ingredients / Generics:
enalapril maleate
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
exemestane
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
exemestane
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
finasteride
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
fluconazole
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
fluconazole
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
gliclazide
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
gliclazide
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
glimepiride
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
oxybutynin
- Change to date of revision
|
Active Ingredients / Generics:
lamotrigine
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
lisinopril dihydrate
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
lorazepam
- Change to, or new, use for medicine
- Change to warnings or special precautions for use
- Change to side-effects
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to information about driving or using machinery
|
Active Ingredients / Generics:
losartan potassium
- Change due to harmonisation of PIL.
- Change to how the medicine works
- Change to date of revision
- Change to warnings or special precautions for use
- Change of contra-indications
- Change to side-effects
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to dosage and administration
|
Active Ingredients / Generics:
ethinylestradiol, desogestrel
- Correction of spelling/typing errors
|
Active Ingredients / Generics:
midazolam hydrochloride
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
montelukast sodium
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
montelukast sodium
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
naltrexone hydrochloride
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
olanzapine
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
olanzapine
- New PIL for eMC ie a PIL for an existing product but one that is new to 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:
paclitaxel
- 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:
paracetamol
- New SPC for eMC ie an SPC for an existing product, but one that is new for 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:
paracetamol
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
lithium citrate
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.6 - Pregnancy and Lactation
- Change to section 5.1 - Pharmacodynamic Properties
- Change to section 6.1 - List of Excipients
- 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 9 - Date of first Authorisation/renewal of the Authorisation
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
quetiapine hemifumarate
- New PIL for eMC ie a PIL for an existing product but one that is new to 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
|
Active Ingredients / Generics:
ropinirole hydrochloride
- Change due to harmonisation of PIL.
- Change to date of revision
|
Active Ingredients / Generics:
ropinirole hydrochloride
- Change due to harmonisation of PIL.
- Change to date of revision
|
Active Ingredients / Generics:
sildenafil citrate
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
sildenafil citrate
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
diclofenac sodium
- 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
|
Active Ingredients / Generics:
sotalol hydrochloride
- 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 warnings or special precautions for use
|
Active Ingredients / Generics:
terazosin monohydrochloride dihydrate
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
terazosin monohydrochloride dihydrate
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
terazosin monohydrochloride dihydrate
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
topiramate
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
topotecan hydrochloride
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
tramadol hydrochloride
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
trimethoprim
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
ursodeoxycholic acid
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic Properties
- Change to section 6.1 - List of Excipients
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
diltiazem hydrochloride
- Change to warnings or special precautions for use
|
Active Ingredients / Generics:
isosorbide mononitrate
- Change to MA holder contact details
|
| |
Active Ingredients / Generics:
alendronate sodium
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
alendronate sodium
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
anastrozole
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
bicalutamide
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
aspirin
- Change of trade or generic name
- Change to packaging
- Change to date of revision
|
Active Ingredients / Generics:
paracetamol
|
Active Ingredients / Generics:
naproxen
- Change of trade or generic name
- Change to packaging
- Change to date of revision
- Change to warnings or special precautions for use
- Change of contra-indications
- Change to side-effects
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to information about driving or using machinery
|
Active Ingredients / Generics:
varenicline tartrate
- Change to section 4.4 - Special warnings and precautions for Use
- Change to section 5.1 - Pharmacodynamic Properties
|
Co-codamol 30/500 Caplets
Active Ingredients / Generics:
paracetamol, codeine phosphate
- Presentation currently not marketed.
|
Co-codamol 30/500mg Capsules
Active Ingredients / Generics:
paracetamol, codeine phosphate
- Presentation currently not marketed.
|
Active Ingredients / Generics:
valsartan
- Change to section 4.4 - Special warnings and precautions for Use
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
valsartan
- Change to section 4.4 - Special warnings and precautions for Use
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
donepezil hydrochloride
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
doxorubicin hydrochloride
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
sodium picosulfate
- Change to section 4.4 - Special warnings and precautions for Use
- Change to section 4.7 - Effects on Ability to Drive and Use Machines
- Change to section 4.8 - Undesirable Effects
|
Active Ingredients / Generics:
sodium picosulfate monohydrate
- Change to section 4.4 - Special warnings and precautions for Use
- Change to section 4.7 - Effects on Ability to Drive and Use Machines
- Change to section 4.8 - Undesirable Effects
|
Active Ingredients / Generics:
parecoxib sodium
- Change/addition of instructions for reconstitution and/ or administration
- Change to information for healthcare professionals
- 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 dosage and administration
|
Active Ingredients / Generics:
parecoxib sodium
- Change/addition of instructions for reconstitution and/ or administration
- Change to information for healthcare professionals
- 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 dosage and administration
|
Active Ingredients / Generics:
ethosuximide
- Change to section 1 -Name of the Medicinal product
|
Estradiol Implant 25mg and 50mg (Organon Laboratories Ltd)
Active Ingredients / Generics:
estradiol
- Retired by Pharmaceutical Company,Individual SPC superseded by joint SPC covering several presentations
|
Estradiol Implants 25mg & 50mg
Active Ingredients / Generics:
estradiol
- Retired by Pharmaceutical Company
|
Active Ingredients / Generics:
finasteride
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
finasteride
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
finasteride
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
fluorouracil
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
fluorouracil
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
amiloride hydrochloride, furosemide
- New individual SPC (was previously included in combined SPC)
|
Active Ingredients / Generics:
furosemide, amiloride hydrochloride anhydrous
- New individual SPC (was previously included in combined SPC)
|
Active Ingredients / Generics:
gadobutrol
- Change to date of revision
|
Active Ingredients / Generics:
gadobutrol
- 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 4.9 - Overdose
- Change to section 5.2 - Pharmacokinetic Properties
- Change to section 5.3 - Preclinical Safety Data
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
gadobutrol
- Change to date of revision
|
Active Ingredients / Generics:
glimepiride
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
glimepiride
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
glimepiride
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
glimepiride
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
spironolactone, furosemide
- Change to section 4.8 - Undesirable Effects
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
furosemide
- Change to section 4.8 - Undesirable Effects
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
letrozole
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
letrozole
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
midazolam hydrochloride
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
midazolam hydrochloride
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
ondansetron hydrochloride dihydrate
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
ondansetron hydrochloride dihydrate
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
oxaliplatin
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
oxaliplatin
- 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:
paracetamol
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
lithium citrate
- Change of inactive ingredient
- Change to storage instructions
- Change to information about pregnancy or lactation
|
Active Ingredients / Generics:
ranitidine hydrochloride
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
ranitidine hydrochloride
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
sertraline hydrochloride
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
sertraline hydrochloride
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
xylometazoline hydrochloride
- New individual SPC (was previously included in combined SPC)
|
Active Ingredients / Generics:
terazosin monohydrochloride dihydrate
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
topotecan hydrochloride
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Trimethoprim Tablets BP 100mg
Active Ingredients / Generics:
trimethoprim
- SPC Product / presentation discontinued
|
Active Ingredients / Generics:
ursodeoxycholic acid
- Change to date of revision
- Change to dosage and administration
|
Active Ingredients / Generics:
nevirapine
- Change to date of revision
- Change to warnings or special precautions for use
- Change to instructions about missed dose
- Change to MA holder contact details
|
Active Ingredients / Generics:
nevirapine anhydrate
- Change to date of revision
- Change to MA holder contact details
|
Active Ingredients / Generics:
nevirapine anhydrate
- Change to date of revision
- Change to MA holder contact details
|
Active Ingredients / Generics:
nevirapine hemihydrate
- Change to date of revision
- Change to warnings or special precautions for use
- Change to instructions about missed dose
- Change to MA holder contact details
|
| |
Active Ingredients / Generics:
nifedipine
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic Properties
|
Active Ingredients / Generics:
nifedipine
- Change to dosage and administration
|
Active Ingredients / Generics:
nifedipine
- Change to dosage and administration
|
Active Ingredients / Generics:
nifedipine
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic Properties
|
Active Ingredients / Generics:
nifedipine
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic Properties
|
Active Ingredients / Generics:
nifedipine
- Change to dosage and administration
|
Active Ingredients / Generics:
alendronate sodium
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
alendronate sodium
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Aminophylline injection B.P. 500 mg /2 ml
Active Ingredients / Generics:
aminophylline hydrate
|
Active Ingredients / Generics:
anastrozole
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
insulin glulisine
- Removal of one or more presentations from joint SPC following discontinuation
|
Active Ingredients / Generics:
guaifenesin
- Change to section 1 -Name of the Medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.1 - Therapeutic indications
- 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 5.1 - Pharmacodynamic Properties
- Change to section 6.1 - List of Excipients
- Change to section 6. 4 - Special Precautions for Storage
- Change to section 6. 6 - Instructions for use, handling and disposal
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
bicalutamide
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
paracetamol
|
Active Ingredients / Generics:
mebeverine hydrochloride
- Change to section 4.2 - Posology and method of administration
- Change to section 4.6 - Pregnancy and Lactation
- Change to section 4.9 - Overdose
- Change to section 5.2 - Pharmacokinetic Properties
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
ciprofloxacin hydrochloride
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
dexamethasone sodium phosphate
- Change to date of revision
- Change of manufacturer
- Change to Marketing Authorisation Holder
|
Active Ingredients / Generics:
sodium picosulfate monohydrate
- Change to date of revision
- Change to side-effects
|
Active Ingredients / Generics:
sodium picosulfate monohydrate
- Change to date of revision
- Change to side-effects
|
Active Ingredients / Generics:
oxaliplatin
- Removal of one or more presentations from joint SPC following discontinuation
|
Active Ingredients / Generics:
iopamidol
- Change to section 4.8 - Undesirable Effects
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
heparin sodium
- Removal of one or more presentations from joint PIL following discontinuation
|
Active Ingredients / Generics:
ibuprofen
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
omeprazole
- Change to section 4.4 - Special warnings and precautions for Use
- Change to section 5.1 - Pharmacodynamic Properties
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
omeprazole
- Change to section 4.4 - Special warnings and precautions for Use
- Change to section 5.1 - Pharmacodynamic Properties
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
omeprazole
- Change to section 4.4 - Special warnings and precautions for Use
- Change to section 5.1 - Pharmacodynamic Properties
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
omeprazole magnesium
- Change to section 4.4 - Special warnings and precautions for Use
- Change to section 5.1 - Pharmacodynamic Properties
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
omeprazole magnesium
- Change to section 4.4 - Special warnings and precautions for Use
- Change to section 5.1 - Pharmacodynamic Properties
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
omeprazole magnesium
- Change to section 4.4 - Special warnings and precautions for Use
- Change to section 5.1 - Pharmacodynamic Properties
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
paracetamol
- 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 4.9 - Overdose
- Change to section 6.1 - List of Excipients
|
Active Ingredients / Generics:
paracetamol
- Change to section 2 - Qualitative and quantitative composition
- 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
- Change to section 6.1 - List of Excipients
|
Active Ingredients / Generics:
somatropin
- Change to section 1 -Name of the Medicinal product
|
Active Ingredients / Generics:
somatropin
- Change to section 1 -Name of the Medicinal product
|
Active Ingredients / Generics:
paracetamol, diphenhydramine 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 4.7 - Effects on Ability to Drive and Use Machines
- Change to section 4.8 - Undesirable Effects
- Change to section 4.9 - Overdose
|
Active Ingredients / Generics:
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 PIL for eMC ie a PIL for an existing product but one that is new to 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:
phenoxybenzamine hydrochloride
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
ketoprofen
- 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 4.8 - Undesirable Effects
- Change to section 6. 5 - Nature and Contents of Container
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
ketoprofen
- Change to date of revision
- Change to warnings or special precautions for use
- Change of contra-indications
- Change to side-effects
|
Active Ingredients / Generics:
buprenorphine hydrochloride
|
Active Ingredients / Generics:
ranitidine hydrochloride
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
prucalopride succinate
|
Active Ingredients / Generics:
prucalopride succinate
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
|
Active Ingredients / Generics:
prucalopride succinate
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
|
Active Ingredients / Generics:
tolnaftate
- Improved Electronic Presentation
|
Active Ingredients / Generics:
sertraline hydrochloride
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
theophylline
- Change to section 3 - Pharmaceutical form
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
diclofenac sodium
- Change to warnings or special precautions for use
- Change of contra-indications
- 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
|
Active Ingredients / Generics:
lidocaine
- Improved Electronic Presentation
|
Active Ingredients / Generics:
zonisamide
- Change to section 4.8 - Undesirable Effects
- Change to section 10 date of revision of the text
|
