Latest medicine updates

196 updates found

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PIL

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	Pantoprazole 20 mg gastro-resistant tablets pantoprazole sodium sesquihydrate Updated 27-Jul-17 Document history Aurobindo Pharma - Milpharm Ltd.		Change to section 2 - what you need to know - warnings and precautions Change to section 6 - date of revision

	Ondansetron 4mg and 8 mg film-coated tablets ondansetron hydrochloride dihydrate Updated 27-Jul-17 Document history Aurobindo Pharma - Milpharm Ltd.		Change to section 6 - date of revision Change to section 3 - dose and frequency Change to section 4 - how to report a side effect

	ViATIM hepatitis a vaccine, typhoid vaccine Updated 27-Jul-17 Document history Sanofi Pasteur		Change to section 6 - date of revision Change to name of medicinal product

	Olmesartan 10mg, 20mg and 40mg film-coated tablets olmesartan medoxomil Updated 27-Jul-17 Document history Aurobindo Pharma - Milpharm Ltd.		Change to section 4 - possible side effects Change to section 6 - date of revision Change to section 2 - use in children/adolescents

	Evoxil (levofloxacin) 250mg film-coated tablets levofloxacin hemihydrate Retired 27-Jul-17 Beacon Pharmaceuticals		Product/presentation currently not marketed

	Evoxil (levofloxacin) 5mg/ml solution for infusion levofloxacin hemihydrate Retired 27-Jul-17 Beacon Pharmaceuticals		Product/presentation currently not marketed

	Olanzapine 2.5mg, 5mg, 7.5mg, 10mg, 15mg & 20mg Tablet olanzapine Updated 27-Jul-17 Document history Aurobindo Pharma - Milpharm Ltd.		Change to section 4 - possible side effects Change to section 6 - date of revision

	Evoxil (levofloxacin) 500mg film-coated tablets levofloxacin hemihydrate Retired 27-Jul-17 Beacon Pharmaceuticals		Product/presentation currently not marketed

	Finasteride 1 mg film-coated tablets finasteride Updated 27-Jul-17 Generics UK T/A Mylan		New PIL for eMC ie a PIL for an existing product but one that is new to the eMC

	ORENCIA 125 mg solution for injection (pre-filled syringe) abatacept Updated 27-Jul-17 Document history Bristol-Myers Squibb Pharmaceutical Limited		Change to section 4.1 - Therapeutic indications 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 10 - Date of revision of the text Change to section 4.8 - Undesirable effects - how to report a side effect

	Nevirapine 200mg tablets nevirapine Updated 27-Jul-17 Aurobindo Pharma - Milpharm Ltd.		New PIL for eMC ie a PIL for an existing product but one that is new to the eMC

	Tranylcypromine 10mg tablets tranylcypromine sulfate Updated 27-Jul-17 Document history Concordia International - formerly AMCo		Change to section 6 - what the product looks like and pack contents Change to section 6 - date of revision Change to section 2 - excipient warnings

	Aciclovir 400mg/5ml Oral Suspension aciclovir Updated 27-Jul-17 Document history Rosemont Pharmaceuticals Limited		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 10 - Date of revision of the text

	Aciclovir 200mg/5ml Oral Suspension aciclovir Updated 27-Jul-17 Document history Rosemont Pharmaceuticals Limited		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 10 - Date of revision of the text

	Montelukast 10 mg film-coated tablets montelukast sodium Updated 27-Jul-17 Document history Aurobindo Pharma - Milpharm Ltd.		Change to section 6 - date of revision

	Insuman Basal 100 IU/ml suspension for injection in a vial human insulin Updated 27-Jul-17 Document history SANOFI		Change to section 10 - Date of revision of the text

	Insuman Basal SoloStar 100 IU/ml suspension for injection in a pre filled pen human insulin Updated 27-Jul-17 Document history SANOFI		Change to section 10 - Date of revision of the text

	Insuman Comb 15 100 IU/ml suspension for injection in a cartridge human insulin Updated 27-Jul-17 Document history SANOFI		Change to section 10 - Date of revision of the text

	Insuman Comb 25 100 IU/ml suspension for injection in a cartridge human insulin Updated 27-Jul-17 Document history SANOFI		Change to section 10 - Date of revision of the text

	Insuman Comb 25 100 IU/ml suspension for injection in a vial human insulin Updated 27-Jul-17 Document history SANOFI		Change to section 10 - Date of revision of the text

	Insuman Comb 25 SoloStar 100 IU/ml suspension for injection in a pre filled pen human insulin Updated 27-Jul-17 Document history SANOFI		Change to section 10 - Date of revision of the text

	Insuman Comb 50 100 IU/ml suspension for injection in a cartridge human insulin Updated 27-Jul-17 Document history SANOFI		Change to section 10 - Date of revision of the text

	Montelukast 5 mg Chewable Tablets montelukast sodium Updated 27-Jul-17 Document history Aurobindo Pharma - Milpharm Ltd.		Change to section 6 - date of revision

	Insuman Infusat 100 IU/ml solution for injection in a cartridge human insulin Updated 27-Jul-17 Document history SANOFI		Change to section 10 - Date of revision of the text

	Insuman Infusat 100 IU/ml solution for injection in a vial human insulin Updated 27-Jul-17 Document history SANOFI		Change to section 10 - Date of revision of the text

	Insuman Basal 100 IU/ml suspension for injection in a cartridge human insulin Updated 27-Jul-17 Document history SANOFI		Change to section 10 - Date of revision of the text

	Montelukast 4 mg chewable tablets montelukast sodium Updated 27-Jul-17 Document history Aurobindo Pharma - Milpharm Ltd.		Change to section 6 - date of revision

	Ramipril 2.5mg/5ml Oral Solution ramipril Updated 27-Jul-17 Document history Rosemont Pharmaceuticals Limited		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 4.8 - Undesirable effects Change to section 4.9 - Overdose Change to section 5.2 - Pharmacokinetic properties Change to section 10 - Date of revision of the text

	Modafinil 100mg and 200mg tablets modafinil Updated 27-Jul-17 Document history Aurobindo Pharma - Milpharm Ltd.		Change to section 2 - what you need to know - warnings and precautions Change to section 3 - overdose, missed or forgotten doses Change to section 4 - possible side effects Change to section 2 - pregnancy, breast feeding and fertility Change to section 6 - date of revision Change to section 3 - how to take/use Change to section 3 - duration of treatment Change to section 4 - how to report a side effect

	Aciclovir 400mg/5ml Oral Suspension aciclovir Updated 27-Jul-17 Document history Rosemont Pharmaceuticals Limited		Change to section 2 - driving and using machines Change to section 6 - date of revision

	Aciclovir 200mg/5ml Oral Suspension aciclovir Updated 27-Jul-17 Document history Rosemont Pharmaceuticals Limited		Change to section 2 - driving and using machines Change to section 6 - date of revision

	Ramipril 2.5mg/5ml Oral Solution ramipril Updated 27-Jul-17 Document history Rosemont Pharmaceuticals Limited		Change to section 2 - what you need to know - warnings and precautions Change to section 4 - possible side effects Change to section 2 - interactions with other medicines, food or drink Change to section 2 - pregnancy, breast feeding and fertility Change to section 6 - date of revision

	Phenindione 10 mg Tablets, Phenindione 25 mg Tablets, Phenindione 50 mg Tablets phenindione Updated 27-Jul-17 Document history Concordia International - formerly AMCo		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 2 - what you need to know - contraindications Change to section 3 - overdose, missed or forgotten doses Change to section 2 - pregnancy, breast feeding and fertility Change to section 6 - date of revision Change to section 1 - what the product is

	MaloffProtect atovaquone, proguanil hydrochloride Updated 27-Jul-17 Document history Glenmark Pharmaceuticals Europe Ltd		Change to section 6.3 - Shelf life Change to section 10 - Date of revision of the text

	Temomedac 5mg hard capsules temozolomide Updated 27-Jul-17 Document history medac GmbH		Change to section 4.4 - Special warnings and precautions for use Change to section 4.8 - Undesirable effects Change to section 10 - Date of revision of the text

	Fybogel Orange ispaghula husk Updated 27-Jul-17 Document history Forum Health Products Limited		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 4.9 - Overdose 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

	Desloratadine 0.5mg/ml Oral Solution (Caduceus) desloratadine Updated 27-Jul-17 Document history Actavis UK Ltd		Change to section 2 - what you need to know - warnings and precautions Change to section 4 - possible side effects Change to section 6 - date of revision Change to section 2 - excipient warnings

	Tranylcypromine 10 mg Tablets tranylcypromine sulfate Updated 27-Jul-17 Document history Concordia International - formerly AMCo		Change to section 4.4 - Special warnings and precautions for use Change to section 6.1 - List of excipients

	Prednisolone 2.5mg and 5mg Gastro-resistant Tablets prednisolone Updated 27-Jul-17 Document history Actavis UK Ltd		Change to section 2 - what you need to know - warnings and precautions Change to section 4 - possible side effects Change to section 6 - date of revision

	Raponer XL 2mg, 4mg and 8mg Prolonged-release Tablets ropinirole hydrochloride Updated 27-Jul-17 Document history Actavis UK Ltd		Removal of one or more presentations from joint PIL

	Mirtazapine 15/30/45mg Tablets mirtazapine Updated 27-Jul-17 Document history Aurobindo Pharma - Milpharm Ltd.		Change to section 4 - possible side effects Change to section 6 - date of revision

	Diamorphine Hydrochloride BP for Injection 5 mg, 10 mg and 30 mg Lyophilisate for Solution for Injection diamorphine hydrochloride Updated 27-Jul-17 Document history Actavis UK Ltd		Change to section 6 - date of revision Change to section 6 - marketing authorisation holder Change to section 6 - marketing authorisation number

	Tramulief SR 100 mg, 150mg and 200mg tablets tramadol hydrochloride Updated 27-Jul-17 Document history Concordia International - formerly AMCo		Change to section 4 - possible side effects Change to section 6 - date of revision

	Fluconazole 200 mg capsules fluconazole Updated 27-Jul-17 Document history Aurobindo Pharma - Milpharm Ltd.		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 - Fertility, pregnancy and lactation Change to section 4.8 - Undesirable effects Change to section 5.1 - Pharmacodynamic properties Change to section 10 - Date of revision of the text

	Escitalopram 10mg tablets escitalopram oxalate Updated 27-Jul-17 Document history Aurobindo Pharma - Milpharm Ltd.		Change to section 10 - Date of revision of the text

	Doxazosin 8mg tablets doxazosin mesilate Updated 27-Jul-17 Document history Aurobindo Pharma - Milpharm Ltd.		Change to section 6.3 - Shelf life Change to section 10 - Date of revision of the text

	Efavirenz 600 mg film-coated tablets efavirenz Updated 27-Jul-17 Document history Aurobindo Pharma - Milpharm Ltd.		Change to section 10 - Date of revision of the text

	Escitalopram 20mg tablets escitalopram oxalate Updated 27-Jul-17 Document history Aurobindo Pharma - Milpharm Ltd.		Change to section 10 - Date of revision of the text

	Mirtazapine 15mg/30mg/45mg OD tablets mirtazapine Updated 27-Jul-17 Document history Aurobindo Pharma - Milpharm Ltd.		Change to section 2 - what you need to know - warnings and precautions Change to section 4 - possible side effects Change to section 2 - interactions with other medicines, food or drink Change to section 6 - date of revision

	Finasteride 5mg Tablets finasteride Updated 27-Jul-17 Document history Aurobindo Pharma - Milpharm Ltd.		Change to section 6.5 - Nature and contents of container Change to section 10 - Date of revision of the text

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