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Document information 22/02/2012 22:59

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Total:	9030

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Updated:	1285
New:	581

What's New

These are the latest new, updated and retired (removed) Summaries of Product Characteristics (known as SPCs or SmPCs) and Patient Information Leaflets (known as PILs, Package Leaflets or PLs) on the eMC website. More help.

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22 February 2012 New 7, Updated 21, Retired 0, [Total 28]
Alendronic Acid 70 mg Tablets Active Ingredients / Generics: alendronate sodium trihydrate Company: Actavis UK Ltd \| Document History 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 Change to section 10 date of revision of the text
Anastrozole 1mg Tablets Active Ingredients / Generics: anastrozole Company: Actavis UK Ltd \| Document History Change to section 2 - Qualitative and quantitative composition 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 5.2 - Pharmacokinetic Properties Change to section 5.3 - Preclinical Safety Data Change to section 10 date of revision of the text
Brevinor Tablets Active Ingredients / Generics: norethisterone, ethinylestradiol Company: Pharmacia Limited \| Document History Change to section 7 - Marketing Authorisation Holder Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
Caprelsa 100 mg & 300 mg film coated tablets Active Ingredients / Generics: vandetanib Company: AstraZeneca UK Limited New SPC for new product
Caprelsa 100 mg & 300 mg film coated tablets Active Ingredients / Generics: vandetanib Company: AstraZeneca UK Limited \| Document History Change to date of revision
CRIXIVAN 200 mg and 400 mg hard capsules Active Ingredients / Generics: indinavir sulphate Company: Merck Sharp & Dohme Limited \| Document History 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 4.8 - Undesirable Effects
Dalacin T Topical Lotion or Clindamycin Phosphate Topical Lotion Active Ingredients / Generics: clindamycin phosphate Company: Pharmacia Limited \| Document History Change to section 5.2 - Pharmacokinetic Properties
Dalacin T Topical Solution Active Ingredients / Generics: clindamycin phosphate Company: Pharmacia Limited \| Document History Change to section 5.2 - Pharmacokinetic Properties
Easyhaler Beclometasone 200 micrograms/dose inhalation powder Active Ingredients / Generics: beclometasone dipropionate Company: Orion Pharma (UK) Limited \| Document History Change to warnings or special precautions for use
Epilim 200 Gastro-resistant Active Ingredients / Generics: sodium valproate Company: sanofi-aventis \| Document History Change to section 1 -Name of the Medicinal product Change to section 3 - Pharmaceutical form Change to section 4.2 - Posology and method of administration Change to section 6. 5 - Nature and Contents of Container Change to section 10 date of revision of the text
Fluoxetine 20mg Capsules Active Ingredients / Generics: fluoxetine hydrochloride Company: Actavis UK Ltd \| Document History Change to section 6.1 - List of Excipients Change to section 10 date of revision of the text
Fosamax Once Weekly 70mg Tablets Active Ingredients / Generics: alendronate sodium trihydrate Company: Merck Sharp & Dohme Limited \| Document History Change to section 4.2 - Posology and method of administration Change to section 5.1 - Pharmacodynamic Properties
Intal CFC-free Inhaler 5mg Pressurised Inhalation, Suspension Active Ingredients / Generics: sodium cromoglicate Company: sanofi-aventis \| Document History Change to name of manufacturer
Jevtana Active Ingredients / Generics: cabazitaxel Company: sanofi-aventis \| Document History Change to section 6. 3 - Shelf Life
Keral Active Ingredients / Generics: dexketoprofen trometamol Company: A.Menarini Pharma U.K. S.R.L. \| Document History Change to date of revision Change to warnings or special precautions for use Change of contra-indications Change to side-effects
Levetiracetam Oral Solution 100mg/ml Active Ingredients / Generics: levetiracetam Company: Actavis UK Ltd \| Document History Change to section 10 date of revision of the text
Mimpara Active Ingredients / Generics: cinacalcet hydrochloride Company: Amgen Ltd \| Document History Change to Further Information section Change to date of revision Change to warnings or special precautions for use Change of contra-indications Change to storage instructions Change to side-effects Change to drug interactions
Mimpara Active Ingredients / Generics: cinacalcet hydrochloride Company: Amgen Ltd \| Document History Change to section 4.4 - Special warnings and precautions for Use Change to section 4.6 - Pregnancy and Lactation Change to section 5.2 - Pharmacokinetic Properties Change to section 6. 6 - Instructions for use, handling and disposal Change to section 10 date of revision of the text
Mirtazapine 30mg Tablets Active Ingredients / Generics: mirtazapine Company: Actavis UK Ltd \| Document History 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 - Pharmacological Properties 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 10 date of revision of the text
Pramipexole Accord 0.088mg tablets Active Ingredients / Generics: pramipexole dihydrochloride monohydrate Company: Accord Healthcare Limited New SPC for new product
Pramipexole Accord 0.18mg tablets Active Ingredients / Generics: pramipexole dihydrochloride monohydrate Company: Accord Healthcare Limited New SPC for new product
Pramipexole Accord 0.35mg tablets Active Ingredients / Generics: pramipexole dihydrochloride monohydrate Company: Accord Healthcare Limited New SPC for new product
Pramipexole Accord 0.7mg tablets Active Ingredients / Generics: pramipexole dihydrochloride monohydrate Company: Accord Healthcare Limited New SPC for new product
Pramipexole Accord 1.1mg tablets Active Ingredients / Generics: pramipexole dihydrochloride monohydrate Company: Accord Healthcare Limited New SPC for new product
Pramipexole Accord tablets Active Ingredients / Generics: pramipexole dihydrochloride monohydrate Company: Accord Healthcare Limited New PIL for new product
Targinact 5 mg/2.5 mg, 10 mg/5 mg, 20 mg/10 mg and 40 mg/20 mg prolonged-release tablets Active Ingredients / Generics: oxycodone hydrochloride, naloxone hydrochloride dihydrate Company: Napp Pharmaceuticals Limited \| Document History Change to warnings or special precautions for use Change to information about pregnancy or lactation
Vectibix Active Ingredients / Generics: panitumumab Company: Amgen Ltd \| Document History Change to section 4.4 - Special warnings and precautions for Use Change to section 10 date of revision of the text
Vectibix Active Ingredients / Generics: panitumumab Company: Amgen Ltd \| Document History Change to side-effects
21 February 2012 New 1, Updated 18, Retired 0, [Total 19]
Anadin LiquiFast 200mg Effervescent Tablets Active Ingredients / Generics: ibuprofen Company: Pfizer Consumer Healthcare \| Document History Unknown
Anusol HC Suppositories Active Ingredients / Generics: zinc oxide, benzyl benzoate, bismuth oxide, bismuth subgallate, balsam peru, hydrocortisone acetate Company: McNeil Products Ltd \| Document History Change to packaging
Anusol Plus HC Suppositories Active Ingredients / Generics: zinc oxide, benzyl benzoate, bismuth oxide, bismuth subgallate, balsam peru, hydrocortisone acetate Company: McNeil Products Ltd \| Document History Change to packaging
APO-go AMPOULES 10mg/ml Solution for Injection or Infusion Active Ingredients / Generics: apomorphine hydrochloride Company: Genus Pharmaceuticals \| Document History Change to Marketing Authorisation Number Change to manufacturer contact details
Avastin 25mg/ml concentrate for solution for infusion Active Ingredients / Generics: bevacizumab Company: Roche Products Limited \| Document History 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 10 date of revision of the text
Brevinor Tablets Active Ingredients / Generics: norethisterone, ethinylestradiol Company: Pharmacia Limited \| Document History Change to Marketing Authorisation Holder
CO-CODAMOL 8/500mg TABLETS Active Ingredients / Generics: paracetamol, codeine phosphate Company: Actavis UK Ltd New SPC for new product
CRIXIVAN 200 mg Capsules Active Ingredients / Generics: indinavir sulphate Company: Merck Sharp & Dohme Limited \| Document History Change to, or new, use for medicine Change to side-effects
CRIXIVAN 400 mg Capsules Active Ingredients / Generics: indinavir sulphate Company: Merck Sharp & Dohme Limited \| Document History Change to, or new, use for medicine Change to side-effects
Fluoxetine Capsules 20mg Active Ingredients / Generics: fluoxetine hydrochloride Company: Actavis UK Ltd \| Document History Change of inactive ingredient Change to date of revision
Fosamax Once Weekly 70mg Tablets Active Ingredients / Generics: alendronate sodium trihydrate Company: Merck Sharp & Dohme Limited \| Document History Correction of spelling/typing errors
IntronA 10 million IU/ml solution for injection or infusion Active Ingredients / Generics: interferon alfa-2b Company: Merck Sharp & Dohme Limited \| Document History Change to Further Information section Change to information about pregnancy or lactation
IntronA 25 million IU/2.5ml solution for injection or infusion Active Ingredients / Generics: interferon alfa-2b Company: Merck Sharp & Dohme Limited \| Document History Change to Further Information section Change to information about pregnancy or lactation
INVANZ 1g powder for concentrate for solution for infusion Active Ingredients / Generics: ertapenem Company: Merck Sharp & Dohme Limited \| Document History Change to Further Information section
Keral Active Ingredients / Generics: dexketoprofen trometamol Company: A.Menarini Pharma U.K. S.R.L. \| Document History 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 10 date of revision of the text
Mirtazapine 30mg Tablets Active Ingredients / Generics: mirtazapine Company: Actavis UK Ltd \| Document History Change of inactive ingredient Change to how the medicine works Change to warnings or special precautions for use Change of contra-indications Change to instructions about overdose Change to storage instructions Change to side-effects Change to drug interactions Change to information about pregnancy or lactation Change to information about driving or using machinery, addition/update of safety device Change to dosage and administration Changes to therapeutic indications
Persantin 100 mg Tablets Active Ingredients / Generics: dipyridamole Company: Boehringer Ingelheim Limited \| Document History Change to section 5.2 - Pharmacokinetic Properties Change to section 10 date of revision of the text
Prochlorperazine Tablets BP 5mg Active Ingredients / Generics: prochlorperazine maleate Company: Actavis UK Ltd \| Document History Change to section 4.6 - Pregnancy and Lactation Change to section 4.8 - Undesirable Effects Change to section 10 date of revision of the text
Questran Powder for Oral Suspension 4g & Questran Light Active Ingredients / Generics: colestyramine Company: Bristol-Myers Squibb Holdings Limited \| Document History Change to date of revision
20 February 2012 New 3, Updated 22, Retired 0, [Total 25]
Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection/Infusion Active Ingredients / Generics: amiodarone hydrochloride Company: hameln pharmaceuticals ltd New SPC for new product
Anastrozole 1mg Tablets Active Ingredients / Generics: anastrozole Company: Actavis UK Ltd \| Document History Change to how the medicine works Change to Further Information section Change to date of revision Change to warnings or special precautions for use Change of contra-indications Change to storage instructions Change to side-effects Change to drug interactions Change to dosage and administration
Clarithromycin 250mg and 500mg Tablets Active Ingredients / Generics: clarithromycin Company: Accord Healthcare Limited \| Document History Change to warnings or special precautions for use Change of contra-indications Change to side-effects Change to drug interactions Change to dosage and administration
Clarithromycin 250mg Tablets Active Ingredients / Generics: clarithromycin Company: Accord Healthcare Limited \| Document History 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 4.1 - 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 5.2 - Pharmacokinetic Properties Change to section 6.1 - List of Excipients Change to section 6. 5 - Nature and Contents of Container
Clarithromycin 500mg Tablets Active Ingredients / Generics: clarithromycin Company: Accord Healthcare Limited \| Document History 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 4.1 - 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 5.2 - Pharmacokinetic Properties Change to section 6.1 - List of Excipients Change to section 6. 5 - Nature and Contents of Container
Dicobalt Edetate Injection 300mg Active Ingredients / Generics: dicobalt edetate Company: Alliance Pharmaceuticals \| Document History Change to section 10 date of revision of the text
Donepezil 5 mg Orodispersible Tablets Active Ingredients / Generics: donepezil hydrochloride Company: Sandoz Limited New SPC for new product
Donepezil Hydrochloride 5 mg Film-coated Tablets Active Ingredients / Generics: donepezil hydrochloride Company: Sandoz Limited New SPC for new product
Femoston 1/10mg Active Ingredients / Generics: dydrogesterone, estradiol hemihydrate Company: Abbott Healthcare Products Limited \| Document History Change to section 3 - Pharmaceutical form 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 4.8 - Undesirable Effects 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 6.1 - List of Excipients
Femoston 2/10mg Active Ingredients / Generics: dydrogesterone, estradiol hemihydrate Company: Abbott Healthcare Products Limited \| Document History Change to section 3 - Pharmaceutical form 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 4.8 - Undesirable Effects 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 6.1 - List of Excipients
Fucibet Lipid cream Active Ingredients / Generics: fusidic acid, betamethasone valerate Company: Leo Laboratories Limited \| Document History Correction of spelling/typing errors
Fucibet Lipid cream Active Ingredients / Generics: fusidic acid, betamethasone valerate Company: Leo Laboratories Limited \| Document History Correction of spelling/typing errors
Gemeprost Active Ingredients / Generics: gemeprost Company: sanofi-aventis \| Document History Change to section 1 -Name of the Medicinal product Change to section 10 date of revision of the text
Otrivine Adult Menthol Nasal Spray Active Ingredients / Generics: xylometazoline hydrochloride Company: Novartis Consumer Health \| Document History 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 Change to section 10 date of revision of the text
Otrivine Adult Nasal Drops Active Ingredients / Generics: xylometazoline hydrochloride Company: Novartis Consumer Health \| Document History 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 Change to section 10 date of revision of the text
Otrivine Adult Nasal Spray Active Ingredients / Generics: xylometazoline hydrochloride Company: Novartis Consumer Health \| Document History 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 Change to section 10 date of revision of the text
Otrivine Allergy Relief 0.1% Nasal Spray Active Ingredients / Generics: xylometazoline hydrochloride Company: Novartis Consumer Health \| Document History 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 Change to section 10 date of revision of the text
Paclitaxel medac 6 mg/ml concentrate for solution for infusion Active Ingredients / Generics: paclitaxel Company: medac GmbH \| Document History Change to section 10 date of revision of the text
Retin-A Gel 0.01% Active Ingredients / Generics: tretinoin Company: Janssen-Cilag Ltd \| Document History Change to section 4.5 - Interaction with other medicinal products and other forms of interaction Change to section 10 date of revision of the text
Retin-A Gel 0.025% Active Ingredients / Generics: tretinoin Company: Janssen-Cilag Ltd \| Document History Change to section 4.5 - Interaction with other medicinal products and other forms of interaction Change to section 10 date of revision of the text
SEROQUEL 25 mg, 100 mg, 150 mg, 200 mg, 300 mg film-coated tablets Active Ingredients / Generics: quetiapine fumarate Company: AstraZeneca UK Limited \| Document History Change to section 4.6 - Pregnancy and Lactation Change to section 4.8 - Undesirable Effects Change to section 10 date of revision of the text
Synflorix suspension for injection in pre-filled syringe Active Ingredients / Generics: Pneumococcal polysaccharide conjugate vaccine Company: GlaxoSmithKline UK \| Document History Improved Electronic Presentation
Telfast 180mg film-coated tablets Active Ingredients / Generics: fexofenadine hydrochloride Company: sanofi-aventis \| Document History Change to side-effects
Viread 245 mg film-coated tablets Active Ingredients / Generics: tenofovir disoproxil fumarate Company: Gilead Sciences Ltd \| Document History Change to section 4.8 - Undesirable Effects Change to section 5.1 - Pharmacodynamic Properties Change to section 10 date of revision of the text
Votubia Tablets 2.5mg, 5mg, 10mg Active Ingredients / Generics: everolimus Company: Novartis Pharmaceuticals UK Ltd \| Document History Change to date of revision Change to side-effects

22 February 2012

New 7, Updated 21, Retired 0, [Total 28]

Alendronic Acid 70 mg Tablets

Active Ingredients / Generics: alendronate sodium trihydrate

Company: Actavis UK Ltd | Document History

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
Change to section 10 date of revision of the text

Anastrozole 1mg Tablets

Active Ingredients / Generics: anastrozole

Company: Actavis UK Ltd | Document History

Change to section 2 - Qualitative and quantitative composition
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 5.2 - Pharmacokinetic Properties
Change to section 5.3 - Preclinical Safety Data
Change to section 10 date of revision of the text

Brevinor Tablets

Active Ingredients / Generics: norethisterone, ethinylestradiol

Company: Pharmacia Limited | Document History

Change to section 7 - Marketing Authorisation Holder
Change to section 8 - MARKETING AUTHORISATION NUMBER(S)

Caprelsa 100 mg & 300 mg film coated tablets

Active Ingredients / Generics: vandetanib

Company: AstraZeneca UK Limited

New SPC for new product

Caprelsa 100 mg & 300 mg film coated tablets

Active Ingredients / Generics: vandetanib

Company: AstraZeneca UK Limited | Document History

Change to date of revision

CRIXIVAN 200 mg and 400 mg hard capsules

Active Ingredients / Generics: indinavir sulphate

Company: Merck Sharp & Dohme Limited | Document History

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 4.8 - Undesirable Effects

Dalacin T Topical Lotion or Clindamycin Phosphate Topical Lotion

Active Ingredients / Generics: clindamycin phosphate

Company: Pharmacia Limited | Document History

Change to section 5.2 - Pharmacokinetic Properties

Dalacin T Topical Solution

Active Ingredients / Generics: clindamycin phosphate

Company: Pharmacia Limited | Document History

Change to section 5.2 - Pharmacokinetic Properties

Easyhaler Beclometasone 200 micrograms/dose inhalation powder

Active Ingredients / Generics: beclometasone dipropionate

Company: Orion Pharma (UK) Limited | Document History

Change to warnings or special precautions for use

Epilim 200 Gastro-resistant

Active Ingredients / Generics: sodium valproate

Company: sanofi-aventis | Document History

Change to section 1 -Name of the Medicinal product
Change to section 3 - Pharmaceutical form
Change to section 4.2 - Posology and method of administration
Change to section 6. 5 - Nature and Contents of Container
Change to section 10 date of revision of the text

Fluoxetine 20mg Capsules

Active Ingredients / Generics: fluoxetine hydrochloride

Company: Actavis UK Ltd | Document History

Change to section 6.1 - List of Excipients
Change to section 10 date of revision of the text

Fosamax Once Weekly 70mg Tablets

Active Ingredients / Generics: alendronate sodium trihydrate

Company: Merck Sharp & Dohme Limited | Document History

Change to section 4.2 - Posology and method of administration
Change to section 5.1 - Pharmacodynamic Properties

Intal CFC-free Inhaler 5mg Pressurised Inhalation, Suspension

Active Ingredients / Generics: sodium cromoglicate

Company: sanofi-aventis | Document History

Change to name of manufacturer

Jevtana

Active Ingredients / Generics: cabazitaxel

Company: sanofi-aventis | Document History

Change to section 6. 3 - Shelf Life

Keral

Active Ingredients / Generics: dexketoprofen trometamol

Company: A.Menarini Pharma U.K. S.R.L. | Document History

Change to date of revision
Change to warnings or special precautions for use
Change of contra-indications
Change to side-effects

Levetiracetam Oral Solution 100mg/ml

Active Ingredients / Generics: levetiracetam

Company: Actavis UK Ltd | Document History

Change to section 10 date of revision of the text

Mimpara

Active Ingredients / Generics: cinacalcet hydrochloride

Company: Amgen Ltd | Document History

Change to Further Information section
Change to date of revision
Change to warnings or special precautions for use
Change of contra-indications
Change to storage instructions
Change to side-effects
Change to drug interactions

Mimpara

Active Ingredients / Generics: cinacalcet hydrochloride

Company: Amgen Ltd | Document History

Change to section 4.4 - Special warnings and precautions for Use
Change to section 4.6 - Pregnancy and Lactation
Change to section 5.2 - Pharmacokinetic Properties
Change to section 6. 6 - Instructions for use, handling and disposal
Change to section 10 date of revision of the text

Mirtazapine 30mg Tablets

Active Ingredients / Generics: mirtazapine

Company: Actavis UK Ltd | Document History

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 - Pharmacological Properties
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 10 date of revision of the text