Change to section 7 - Marketing authorisation holder

smpc Canesten Hydrocortisone (with acetate)

clotrimazole, hydrocortisone acetate

Bayer plc

Updated 20-May-18

Document history

Change to section 10 - Date of revision of the text

Change to section 9 - Date of first authorisation/renewal of the authorisation

smpc Canesten HC Cream (with acetate)

clotrimazole, hydrocortisone acetate

Bayer plc

Updated 20-May-18

Document history

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

smpc Cabometyx 20mg

cabozantinib

Ipsen Ltd

Updated 18-May-18

Document history

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

smpc Cabometyx 60mg

cabozantinib

Ipsen Ltd

Updated 18-May-18

Document history

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

smpc Cabometyx 40mg

cabozantinib

Ipsen Ltd

Updated 18-May-18

Document history

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

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

pil Deponit 10

glyceryl trinitrate

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

pil Deponit 5

glyceryl trinitrate

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

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

New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

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

pil Lonquex

lipegfilgrastim

Teva Pharma B.V.

Updated 18-May-18

Document history

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

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 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 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 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 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 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 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 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 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

smpc Frumil LS

furosemide, amiloride hydrochloride anhydrous

SANOFI

Updated 18-May-18

Document history

Change to section 10 - Date of revision of the text

Change to section 4.8 - Undesirable effects

smpc Frumil

amiloride hydrochloride, furosemide

SANOFI

Updated 18-May-18

Document history

Change to section 10 - Date of revision of the text

Change to section 4.8 - Undesirable effects

New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

smpc 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

smpc 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

smpc Lasilactone capsules

spironolactone, furosemide

SANOFI

Updated 18-May-18

Document history

Change to section 10 - Date of revision of the text

Change to section 4.8 - Undesirable effects

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

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

Change to section 6.5 - Nature and contents of container