Change to section 7 - Marketing authorisation holder
Canesten Hydrocortisone (with acetate)
clotrimazole, hydrocortisone acetate
Bayer plc
Updated 20-May-18
Change to section 10 - Date of revision of the text
Change to section 9 - Date of first authorisation/renewal of the authorisation
Change to section 10 - Date of revision of the text
Change to section 9 - Date of first authorisation/renewal of the authorisation
Change to section 10 - Date of revision of the text
Improved presentation of SPC
Improved presentation of SPC
Change to section 10 - Date of revision of the text
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 - how to report a side effect
Change to section 5.1 - Pharmacodynamic properties
Change to section 5.2 - Pharmacokinetic properties
Change to section 9 - Date of first authorisation/renewal of the authorisation
Improved presentation of SPC
Change to section 10 - Date of revision of the text
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 - how to report a side effect
Change to section 5.1 - Pharmacodynamic properties
Change to section 5.2 - Pharmacokinetic properties
Change to section 9 - Date of first authorisation/renewal of the authorisation
Improved presentation of SPC
Change to section 10 - Date of revision of the text
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 - how to report a side effect
Change to section 5.1 - Pharmacodynamic properties
Change to section 5.2 - Pharmacokinetic properties
Change to section 9 - Date of first authorisation/renewal of the authorisation
Improved presentation of SPC
New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
Change to section 2 - what you need to know - warnings and precautions
Change to section 4 - possible side effects
Change to section 6 - what the product looks like and pack contents
Change to section 2 - what you need to know - warnings and precautions
Change to section 4 - possible side effects
Change to section 6 - what the product looks like and pack contents
Change to section 2 - what you need to know - warnings and precautions
Change to section 4 - possible side effects
Change to section 6 - what the product looks like and pack contents
Change to section 2 - interactions with other medicines, food or drink
Change to section 2 - use in children/adolescents
Change to section 4 - how to report a side effect
Change to section 4 - possible side effects
Change to section 2 - interactions with other medicines, food or drink
Change to section 2 - use in children/adolescents
Change to section 4 - how to report a side effect
Change to section 4 - possible side effects
Elantan LA 50 mg prolonged release capsules
isosorbide mononitrate
Merus Labs Luxco S.a.R.L.
New 18-May-18
New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
Elantan LA 25 mg prolonged release capsules
isosorbide mononitrate
Merus Labs Luxco S.a.R.L.
New 18-May-18
New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
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 - Fertility, 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 4.8 - Undesirable effects - how to report a side effect
Change to section 4.9 - Overdose
Change to section 5.1 - Pharmacodynamic properties
Change to section 5.2 - Pharmacokinetic properties
Change to section 5.3 - Preclinical safety data
Elantan LA 25 mg prolonged release capsules
isosorbide mononitrate
Merus Labs Luxco S.a.R.L.
New 18-May-18
New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
Azithromycin 200mg/5ml Powder for Oral Suspension
azithromycin monohydrate
Sandoz Limited
Updated 18-May-18
Change to section 10 - Date of revision of the text
Change to section 2 - Qualitative and quantitative composition
Change to section 3 - Pharmaceutical form
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 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 - Special precautions for disposal and other handling
Change to section 4 - possible side effects
Change to section 6 - date of revision
Change to section 6 - what the product looks like and pack contents
Removal of black triangle
Change to section 6 - date of revision
Change to section 6 - what the product looks like and pack contents
Removal of black triangle
Change to section 6 - date of revision
Change to section 6 - what the product looks like and pack contents
Removal of black triangle
Change to section 10 - Date of revision of the text
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 5.1 - Pharmacodynamic properties
Change to section 5.2 - Pharmacokinetic properties
Change to section 6.1 - List of excipients
Change to section 6.5 - Nature and contents of container
Change to section 9 - Date of first authorisation/renewal of the authorisation
Removal of black triangle
Change to section 10 - Date of revision of the text
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 5.1 - Pharmacodynamic properties
Change to section 5.2 - Pharmacokinetic properties
Change to section 6.1 - List of excipients
Change to section 6.5 - Nature and contents of container
Change to section 9 - Date of first authorisation/renewal of the authorisation
Removal of black triangle
Change to section 10 - Date of revision of the text
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 5.1 - Pharmacodynamic properties
Change to section 5.2 - Pharmacokinetic properties
Change to section 6.1 - List of excipients
Change to section 6.5 - Nature and contents of container
Change to section 9 - Date of first authorisation/renewal of the authorisation
Removal of black triangle
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 - Fertility, 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 4.8 - Undesirable effects - how to report a side effect
Change to section 4.9 - Overdose
Change to section 5.1 - Pharmacodynamic properties
Change to section 5.2 - Pharmacokinetic properties
Change to section 5.3 - Preclinical safety data
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 - Fertility, pregnancy and lactation
Change to section 4.8 - Undesirable effects
Change to section 4.8 - Undesirable effects - how to report a side effect
Change to section 4.9 - Overdose
Change to section 5.1 - Pharmacodynamic properties
Change to section 5.2 - Pharmacokinetic properties
Change to section 5.3 - Preclinical safety data
Methofill 7.5 mg solution for injection in pre-filled injector
methotrexate
Accord Healthcare Limited
Updated 18-May-18
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 - Fertility, pregnancy and lactation
Change to section 4.8 - Undesirable effects
Change to section 5.2 - Pharmacokinetic properties
Methofill 30 mg solution for injection in pre-filled injector
methotrexate
Accord Healthcare Limited
Updated 18-May-18
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 - Fertility, pregnancy and lactation
Change to section 4.8 - Undesirable effects
Change to section 5.2 - Pharmacokinetic properties
Methofill 27.5 mg solution for injection in pre-filled injector
methotrexate
Accord Healthcare Limited
Updated 18-May-18
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 - Fertility, pregnancy and lactation
Change to section 4.8 - Undesirable effects
Change to section 5.2 - Pharmacokinetic properties
Methofill 25 mg solution for injection in pre-filled injector
methotrexate
Accord Healthcare Limited
Updated 18-May-18
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 - Fertility, pregnancy and lactation
Change to section 4.8 - Undesirable effects
Change to section 5.2 - Pharmacokinetic properties
Methofill 22.5 mg solution for injection in pre-filled injector
methotrexate
Accord Healthcare Limited
Updated 18-May-18
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 - Fertility, pregnancy and lactation
Change to section 4.8 - Undesirable effects
Change to section 5.2 - Pharmacokinetic properties
Methofill 20 mg solution for injection in pre-filled injector
methotrexate
Accord Healthcare Limited
Updated 18-May-18
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 - Fertility, pregnancy and lactation
Change to section 4.8 - Undesirable effects
Change to section 5.2 - Pharmacokinetic properties
Methofill 17.5 mg solution for injection in pre-filled injector
methotrexate
Accord Healthcare Limited
Updated 18-May-18
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 - Fertility, pregnancy and lactation
Change to section 4.8 - Undesirable effects
Change to section 5.2 - Pharmacokinetic properties
Methofill 15 mg solution for injection in pre-filled injector
methotrexate
Accord Healthcare Limited
Updated 18-May-18
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 - Fertility, pregnancy and lactation
Change to section 4.8 - Undesirable effects
Change to section 5.2 - Pharmacokinetic properties
Methofill 12.5 mg solution for injection in pre-filled injector
methotrexate
Accord Healthcare Limited
Updated 18-May-18
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 - Fertility, pregnancy and lactation
Change to section 4.8 - Undesirable effects
Change to section 5.2 - Pharmacokinetic properties
Change to section 10 - Date of revision of the text
Change to section 4.8 - Undesirable effects
Change to section 7 - Marketing authorisation holder
Change to section 10 - Date of revision of the text
Change to section 4.8 - Undesirable effects
Change to section 10 - Date of revision of the text
Change to section 4.8 - Undesirable effects
Elantan LA 50 mg prolonged release capsules
isosorbide mononitrate
Merus Labs Luxco S.a.R.L.
New 18-May-18
New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
Insuman Comb 25 and Insuman Comb 25 SoloStar 100 IU-ml suspension for injection in a vial, cartridge and pre-filled pen
insulin
SANOFI
Retired 18-May-18
Joint SPC superseded by individual SPCs
Insuman Basal and Insuman Basal SoloStar 100IU-ml suspension for injection in a vial, cartridge and pre-filled pen
human insulin
SANOFI
Retired 18-May-18
Joint SPC superseded by individual SPCs
Change to section 10 - Date of revision of the text
Change to section 4.8 - Undesirable effects
Metronidazole Rosemont 200mg/5ml Oral Suspension
metronidazole benzoate
Rosemont Pharmaceuticals Limited
Updated 18-May-18
Change to section 2 - interactions with other medicines, food or drink
Change to section 2 - what you need to know - contraindications
Change to section 4 - how to report a side effect
Change to section 4 - possible side effects
Change to section 6 - date of revision
New PIL for new product
Aloxi 500 micrograms soft capsules
palonosetron hydrochloride
Chugai Pharma UK Limited
Updated 18-May-18
Change to section 10 - Date of revision of the text
Change to section 2 - Qualitative and quantitative composition
Change to section 3 - Pharmaceutical form
Change to section 4.8 - Undesirable effects - how to report a side effect
Change to section 6.1 - List of excipients
Donepezil Hydrochloride 10 mg Film-coated tablets
donepezil hydrochloride monohydrate
Accord Healthcare Limited
Updated 18-May-18
Change to section 6.5 - Nature and contents of container
