Change to section 2 - what you need to know - warnings and precautions

Change to section 4 - how to report a side effect

Change to section 4 - possible side effects

Change to section 6 - date of revision

Change to section 2 - interactions with other medicines, food or drink

Change to section 2 - pregnancy, breast feeding and fertility

Change to section 2 - what you need to know - contraindications

Change to section 2 - what you need to know - warnings and precautions

Change to section 6 - date of revision

Change to section 2 - interactions with other medicines, food or drink

Change to section 2 - pregnancy, breast feeding and fertility

Change to section 2 - what you need to know - contraindications

Change to section 2 - what you need to know - warnings and precautions

Change to section 6 - date of revision

Change to section 2 - interactions with other medicines, food or drink

Change to section 2 - pregnancy, breast feeding and fertility

Change to section 2 - what you need to know - contraindications

Change to section 2 - what you need to know - warnings and precautions

Change to section 6 - date of revision

Change to section 2 - interactions with other medicines, food or drink

Change to section 2 - pregnancy, breast feeding and fertility

Change to section 2 - what you need to know - contraindications

Change to section 2 - what you need to know - warnings and precautions

Change to section 6 - date of revision

Change to section 2 - interactions with other medicines, food or drink

Change to section 2 - pregnancy, breast feeding and fertility

Change to section 2 - what you need to know - contraindications

Change to section 2 - what you need to know - warnings and precautions

Change to section 6 - date of revision

Change to section 2 - interactions with other medicines, food or drink

Change to section 2 - pregnancy, breast feeding and fertility

Change to section 2 - what you need to know - contraindications

Change to section 2 - what you need to know - warnings and precautions

Change to section 6 - date of revision

Change to section 2 - interactions with other medicines, food or drink

Change to section 2 - pregnancy, breast feeding and fertility

Change to section 2 - what you need to know - contraindications

Change to section 2 - what you need to know - warnings and precautions

Change to section 6 - date of revision

smpc Seretide 100 Accuhaler

fluticasone propionate, salmeterol xinafoate

GlaxoSmithKline UK

Updated 15-Dec-17

Document history

Change to section 10 - Date of revision of the text

Change to section 2 - Qualitative and quantitative composition

Change to section 4.4 - Special warnings and precautions for use

smpc Seretide 500 Accuhaler

fluticasone propionate, salmeterol xinafoate

GlaxoSmithKline UK

Updated 15-Dec-17

Document history

Change to section 10 - Date of revision of the text

Change to section 2 - Qualitative and quantitative composition

Change to section 4.4 - Special warnings and precautions for use

smpc Seretide 250 Accuhaler

fluticasone propionate, salmeterol xinafoate

GlaxoSmithKline UK

Updated 15-Dec-17

Document history

Change to section 10 - Date of revision of the text

Change to section 2 - Qualitative and quantitative composition

Change to section 4.4 - Special warnings and precautions for use

Improved presentation of PIL

pil Combodart 0.5 mg / 0.4 mg hard capsules

tamsulosin hydrochloride, dutasteride

GlaxoSmithKline UK

Updated 15-Dec-17

Document history

Change to section 2 - interactions with other medicines, food or drink

Change to section 4 - how to report a side effect

Change to section 4 - possible side effects

Change to section 6 - date of revision

Improved presentation of PIL

Change to section 4 - possible side effects

Change to section 6 - date of revision

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 - how to report a side effect

Change to section 4 - possible side effects

Change to section 10 - Date of revision of the text

Change to section 4.2 - Posology and method of administration

Change to section 4.8 - Undesirable effects

Change to section 5.1 - Pharmacodynamic properties

Change to section 5.2 - Pharmacokinetic properties

Change to section 2 - what you need to know - warnings and precautions

Change to section 4 - how to report a side effect

Change to section 6 - date of revision

Change to section 2 - what you need to know - warnings and precautions

Change to section 4 - how to report a side effect

Change to section 6 - date of revision

Change to section 2 - what you need to know - warnings and precautions

Change to section 4 - how to report a side effect

Change to section 6 - date of revision

Change to section 2 - what you need to know - warnings and precautions

Change to section 4 - how to report a side effect

Change to section 6 - date of revision

Change to section 2 - what you need to know - warnings and precautions

Change to section 4 - how to report a side effect

Change to section 4 - possible side effects

Change to section 6 - date of revision

pil Seretide 100 Accuhaler

fluticasone propionate, salmeterol xinafoate

GlaxoSmithKline UK

Updated 15-Dec-17

Document history

Change to section 2 - excipient warnings

Change to section 6 - date of revision

pil Seretide 250 Accuhaler

fluticasone propionate, salmeterol xinafoate

GlaxoSmithKline UK

Updated 15-Dec-17

Document history

Change to section 2 - excipient warnings

Change to section 6 - date of revision

pil Seretide 500 Accuhaler

fluticasone propionate, salmeterol xinafoate

GlaxoSmithKline UK

Updated 15-Dec-17

Document history

Change to section 2 - excipient warnings

Change to section 6 - date of revision

Change to section 10 - Date of revision of the text

Change to section 4.8 - Undesirable effects

Change to section 4.8 - Undesirable effects - how to report a side effect

Change to section 5.1 - Pharmacodynamic properties

Change to section 6.5 - Nature and contents of container

Change to section 2 - what you need to know - warnings and precautions

Change to section 4 - how to report a side effect

Change to section 4 - possible side effects

Change to section 6 - date of revision

Change to section 10 - Date of revision of the text

Change to section 4.8 - Undesirable effects

Change to section 5.1 - Pharmacodynamic properties

Improved presentation of SPC

smpc Lustral 50mg film coated tablets

sertraline hydrochloride

Pfizer Limited

Updated 15-Dec-17

Document history

Change to section 4.8 - Undesirable effects

Change to section 8 - Marketing authorisation number(s)

smpc LUSTRAL 100mg film coated tablets

sertraline hydrochloride

Pfizer Limited

Updated 15-Dec-17

Document history

Change to section 4.8 - Undesirable effects

Change to section 8 - Marketing authorisation number(s)

pil Innovace Tablets

enalapril maleate

Merck Sharp & Dohme Limited

Updated 15-Dec-17

Document history

Change to section 3 - how to take/use

Change to section 4 - how to report a side effect

smpc Ketalar 100 mg/ml Injection

aciclovir

GlaxoSmithKline UK

Retired 15-Dec-17

Product/presentation currently not marketed

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

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

smpc Nebivolol 5 mg Tablets

nebivolol hydrochloride

Generics UK T/A Mylan

New 15-Dec-17

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

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

Change to section 2 - Qualitative and quantitative composition

Change to section 3 - Pharmaceutical form

Change to section 4.1 - Therapeutic indications

Change to section 4.3 - Contraindications

Change to section 4.4 - Special warnings and precautions for use

Change to section 4.6 - Fertility, pregnancy and lactation

Change to section 4.9 - Overdose

Change to section 5.2 - Pharmacokinetic properties

Change to section 6.2 - Incompatibilities

Change to section 6.5 - Nature and contents of container

Change to section 6.6 - Special precautions for disposal and other handling

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

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 6.3 - Shelf life

Change to section 10 - Date of revision of the text

Change to section 6.3 - Shelf life

smpc Raponer XL 2mg Prolonged-release Tablets

ropinirole hydrochloride

Actavis UK Ltd

Updated 15-Dec-17

Document history

Change to section 10 - Date of revision of the text

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 9 - Date of first authorisation/renewal of the authorisation

smpc Raponer XL 4mg Prolonged-release Tablets

ropinirole hydrochloride

Actavis UK Ltd

Updated 15-Dec-17

Document history

Change to section 10 - Date of revision of the text

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 9 - Date of first authorisation/renewal of the authorisation

smpc Raponer XL 8mg Prolonged-release Tablets

ropinirole hydrochloride

Actavis UK Ltd

Updated 15-Dec-17

Document history

Change to section 10 - Date of revision of the text

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 9 - Date of first authorisation/renewal of the authorisation

smpc Cymalon

sodium bicarbonate, sodium citrate dihydrate, sodium carbonate, citric acid, anhydrous

Actavis UK Ltd

Updated 15-Dec-17

Document history

Change to section 10 - Date of revision of the text

Change to section 2 - Qualitative and quantitative composition

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 - Fertility, pregnancy and lactation

Change to section 4.8 - Undesirable effects

Change to section 10 - Date of revision of the text

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

Change to section 4.4 - Special warnings and precautions for use

Change to section 4.8 - Undesirable effects - how to report a side effect

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

Change to other sources of information section

Change to section 4 - possible side effects

Change to section 4 - how to report a side effect

Change to section 4 - possible side effects

Change to section 6 - date of revision