| |
Active Ingredients / Generics:
influenza vaccine (surface antigen, inactivated)
- Change to section 2 - Qualitative and quantitative composition
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
paracetamol, caffeine, phenylephrine 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 4.8 - Undesirable Effects
- Change to section 4.9 - Overdose
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
paracetamol, phenylephrine hydrochloride, guaifenesin
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
paracetamol, phenylephrine hydrochloride, guaifenesin
- 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 4.9 - Overdose
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
paracetamol, phenylephrine hydrochloride, guaifenesin
- 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
- Change to section 4.9 - Overdose
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
paracetamol, phenylephrine hydrochloride, guaifenesin
- 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
- Change to section 4.9 - Overdose
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
paracetamol, phenylephrine hydrochloride, ascorbic acid (vitamin c)
- 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
- Change to section 4.9 - Overdose
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
paracetamol, phenylephrine hydrochloride, ascorbic acid (vitamin c)
- 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
- Change to section 4.9 - Overdose
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
paracetamol, caffeine, phenylephrine 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 4.8 - Undesirable Effects
- Change to section 4.9 - Overdose
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
paracetamol, phenylephrine hydrochloride, ascorbic acid (vitamin c)
- 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
- Change to section 4.9 - Overdose
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
paracetamol, caffeine, phenylephrine 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 4.8 - Undesirable Effects
- Change to section 4.9 - Overdose
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
paracetamol, phenylephrine hydrochloride, ascorbic acid (vitamin c)
- 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
- Change to section 4.9 - Overdose
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
paracetamol, caffeine, phenylephrine 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 4.8 - Undesirable Effects
- Change to section 4.9 - Overdose
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
influenza vaccine
- Change to section 2 - Qualitative and quantitative composition
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
calcium carbonate
- Change to side-effects
- Change to drug interactions
|
Active Ingredients / Generics:
calcium carbonate, colecalciferol (vitamin d3)
- Change to date of revision
- Change to side-effects
- Change to drug interactions
|
Active Ingredients / Generics:
calcium carbonate, colecalciferol (vitamin d3)
- Change to side-effects
- Change to drug interactions
|
Active Ingredients / Generics:
calcium carbonate
- Change to date of revision
- Change to side-effects
- Change to drug interactions
|
Active Ingredients / Generics:
captopril
- Change to section 4.9 - Overdose
|
Active Ingredients / Generics:
miconazole
- Change to section 4.8 - Undesirable Effects
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
dihydrocodeine tartrate
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
aspirin
- Change to section 4.3 - Contraindications
- 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
|
Active Ingredients / Generics:
lactulose
- Change to section 4.4 - Special warnings and precautions for Use
- Change to section 4.6 - Pregnancy and Lactation
- Change to section 5.3 - Preclinical Safety Data
|
Active Ingredients / Generics:
influenza vaccine (surface antigen, inactivated)
- Change to section 2 - Qualitative and quantitative composition
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
furosemide
- Change to section 5.1 - Pharmacodynamic Properties
- Change to section 5.2 - Pharmacokinetic Properties
|
Active Ingredients / Generics:
human papillomavirus vaccine
- Change to, or new, use for medicine
|
Active Ingredients / Generics:
haloperidol
- 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:
octocog alfa
- 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 4.2 - 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 4.6 - Pregnancy and Lactation
- Change to section 4.8 - Undesirable Effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic Properties
- 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:
influenza vaccine (split virion, inactivated)
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
testosterone
- Change to section 7 - Marketing Authorisation Holder
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
metoclopramide hydrochloride
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
sorafenib tosilate
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for Use
- Change to section 4.6 - Pregnancy and Lactation
- Change to section 4.8 - Undesirable Effects
- Change to section 5.1 - Pharmacodynamic Properties
- Change to section 5.2 - Pharmacokinetic Properties
- Change to section 6.1 - List of Excipients
- Change to section 6. 6 - Instructions for use, handling and disposal
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
ondansetron hydrochloride dihydrate
- 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 5.1 - Pharmacodynamic Properties
- Change to section 5.2 - Pharmacokinetic Properties
|
Active Ingredients / Generics:
ondansetron hydrochloride dihydrate
- 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 5.1 - Pharmacodynamic Properties
- Change to section 5.2 - Pharmacokinetic Properties
|
Active Ingredients / Generics:
influenza vaccine (split virion, inactivated)
- Correction of spelling/typing errors
|
Active Ingredients / Generics:
diltiazem hydrochloride
- 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:
paracetamol, caffeine, codeine phosphate hemihydrate
- Change to section 6.1 - List of Excipients
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
erlotinib hydrochloride
- Change to section 6. 3 - Shelf Life
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
warfarin sodium
- Change to date of revision
- Change of manufacturer
- Change of contra-indications
- Change to side-effects
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to name of manufacturer
|
Active Ingredients / Generics:
cefuroxime sodium
- Change to date of revision
- Change to warnings or special precautions for use
- Change due to user-testing of patient information
|
| |
Active Ingredients / Generics:
terbutaline sulphate
- Correction of spelling/typing errors
|
Active Ingredients / Generics:
calcium carbonate
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for Use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable Effects
- Change to section 4.9 - Overdose
|
Active Ingredients / Generics:
calcium carbonate, colecalciferol (vitamin d3)
- 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
|
Active Ingredients / Generics:
calcium carbonate, colecalciferol (vitamin d3)
- 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
|
Active Ingredients / Generics:
calcium carbonate
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for Use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable Effects
- Change to section 4.9 - Overdose
|
Active Ingredients / Generics:
clomifene citrate
|
Active Ingredients / Generics:
clomifene citrate
- Change to section 4.4 - Special warnings and precautions for Use
- Change to section 4.8 - Undesirable Effects
|
Active Ingredients / Generics:
miconazole
- Change to section 4.8 - Undesirable Effects
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
daunorubicin hydrochloride
- 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:
daunorubicin 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:
bisacodyl
- Change to section 5.1 - Pharmacodynamic Properties
- Change to section 5.2 - Pharmacokinetic Properties
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
bisacodyl
- Change to section 5.1 - Pharmacodynamic Properties
- Change to section 5.2 - Pharmacokinetic Properties
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
bisacodyl
- Change to section 5.1 - Pharmacodynamic Properties
- Change to section 5.2 - Pharmacokinetic Properties
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
human papillomavirus vaccine
- Change to section 4.1 - Therapeutic indications
- Change to section 4.4 - Special warnings and precautions for Use
- Change to section 4.6 - Pregnancy and Lactation
- Change to section 5.1 - Pharmacodynamic Properties
|
Active Ingredients / Generics:
lamivudine, abacavir sulfate
- Change to Marketing Authorisation Holder
- Change to manufacturer contact details
|
Active Ingredients / Generics:
ethinylestradiol, norethisterone acetate
- Change to section 4.4 - Special warnings and precautions for Use
|
Active Ingredients / Generics:
ethinylestradiol, norethisterone acetate
- Change to section 4.4 - Special warnings and precautions for Use
|
Active Ingredients / Generics:
sorafenib tosilate
- Change to date of revision
- Change to warnings or special precautions for use
- Change of contra-indications
- Change to side-effects, Extra statutory information
|
Active Ingredients / Generics:
hydrocortisone, lidocaine hydrochloride
- 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:
lithium carbonate
- Change to section 5.2 - Pharmacokinetic Properties
|
Active Ingredients / Generics:
lithium citrate
- Change to section 5.2 - Pharmacokinetic Properties
|
Active Ingredients / Generics:
prucalopride succinate
- Change to Further Information section
- Change to date of revision
- Change to manufacturer contact details
|
Active Ingredients / Generics:
prucalopride succinate
- Change to section 6. 5 - Nature and Contents of Container
- 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
|
Active Ingredients / Generics:
prucalopride succinate
- Change to section 6. 5 - Nature and Contents of Container
- 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
|
Active Ingredients / Generics:
prednisolone hexanoate, cinchocaine hydrochloride
- Removal/change of distributor
|
Active Ingredients / Generics:
prednisolone hexanoate, cinchocaine hydrochloride
- Removal/change of distributor
|
Active Ingredients / Generics:
azelaic acid
- Removal/change of distributor
|
Active Ingredients / Generics:
No Active Ingredients
- Removal/change of distributor
|
Active Ingredients / Generics:
cilazapril monohydrate
- 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
|
Active Ingredients / Generics:
lamivudine
- 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 4.5 - 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 9 - Date of first Authorisation/renewal of the Authorisation
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
lamivudine
- 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 4.5 - 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 9 - Date of first Authorisation/renewal of the Authorisation
- Change to section 10 date of revision of the text
|
| |
Active Ingredients / Generics:
erythromycin, tretinoin
- New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
|
Active Ingredients / Generics:
ciclesonide
- Improved Electronic Presentation
|
Active Ingredients / Generics:
captopril
- Change to section 4.9 - Overdose
|
Active Ingredients / Generics:
captopril
- Change to section 4.9 - Overdose
|
Active Ingredients / Generics:
podophyllotoxin
- Improved Electronic Presentation
|
Active Ingredients / Generics:
tacalcitol monohydrate
- Change to Marketing Authorisation Holder
|
Active Ingredients / Generics:
bisacodyl
- Change to section 5.1 - Pharmacodynamic Properties
- Change to section 5.2 - Pharmacokinetic Properties
- Change to section 10 date of revision of the text
|
Active Ingredients / Generics:
fentanyl citrate
|
Active Ingredients / Generics:
nitrofurantoin
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
Active Ingredients / Generics:
nitrofurantoin
- Change to section 4.7 - Effects on Ability to Drive and Use Machines
|
Active Ingredients / Generics:
hydroxycarbamide
- Change due to user-testing of patient information
- Change to name of manufacturer
|
Active Ingredients / Generics:
fentanyl citrate
- Improved Electronic Presentation
|
Active Ingredients / Generics:
influenza vaccine
- Change to section 2 - Qualitative and quantitative composition
|
Active Ingredients / Generics:
ethinylestradiol, norethisterone acetate
- Change to date of revision
- Change to warnings or special precautions for use
|
Active Ingredients / Generics:
nitrofurantoin
- Change to section 4.7 - Effects on Ability to Drive and Use Machines
|
Active Ingredients / Generics:
nitrofurantoin
- Change to section 4.7 - Effects on Ability to Drive and Use Machines
|
Active Ingredients / Generics:
nitrofurantoin
- Change to section 4.7 - Effects on Ability to Drive and Use Machines
|
Active Ingredients / Generics:
fentanyl
- Improved Electronic Presentation
|
Active Ingredients / Generics:
pantoprazole sodium sesquihydrate
- Improved Electronic Presentation
|
Active Ingredients / Generics:
pantoprazole sodium sesquihydrate
- Improved Electronic Presentation
|
Active Ingredients / Generics:
phenindione
|
Active Ingredients / Generics:
phenindione
|
Active Ingredients / Generics:
procarbazine 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
|
Active Ingredients / Generics:
pantoprazole sodium
- Improved Electronic Presentation
|
Active Ingredients / Generics:
triamterene
- 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
- Improved Electronic Presentation
|
Active Ingredients / Generics:
etoposide
- Change due to user-testing of patient information
- Change to name of manufacturer
|