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Document information 28/01/2012 12:52

Current documents
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	3866
Total:	8741

Submissions in the last 3 months
Updated:	1344
New:	533

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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27 January 2012 New 4, Updated 31, Retired 0, [Total 35]
Arythmol 150mg and 300mg Tablets Active Ingredients / Generics: propafenone hydrochloride Company: Abbott Laboratories 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 4.6 - Pregnancy and Lactation Change to section 4.8 - Undesirable Effects Change to section 4.9 - Overdose
Budenofalk 2mg/dose rectal foam Active Ingredients / Generics: budesonide Company: Dr. Falk Pharma UK Ltd \| Document History Change to section 4.4 - Special warnings and precautions for Use
Burinex 1mg Tablets Active Ingredients / Generics: bumetanide Company: Leo Laboratories Limited \| Document History Change to section 6. 3 - Shelf Life Change to section 10 date of revision of the text
Burinex 5mg Tablets Active Ingredients / Generics: bumetanide Company: Leo Laboratories Limited \| Document History Change to section 6. 3 - Shelf Life Change to section 10 date of revision of the text
Cipramil Drops 40 mg/ml Active Ingredients / Generics: citalopram hydrochloride Company: Lundbeck 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
Cipramil Drops 40 mg/ml Active Ingredients / Generics: citalopram hydrochloride Company: Lundbeck 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 Change to section 4.9 - Overdose Change to section 5.1 - Pharmacodynamic Properties Change to section 10 date of revision of the text
Cipramil Tablets Active Ingredients / Generics: citalopram hydrobromide Company: Lundbeck 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 Change to section 4.9 - Overdose Change to section 5.1 - Pharmacodynamic Properties Change to section 10 date of revision of the text
Cipramil Tablets Active Ingredients / Generics: citalopram hydrobromide Company: Lundbeck 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
Creon 10000 Capsules Active Ingredients / Generics: pancreatin Company: Abbott Healthcare Products Limited \| Document History Change to side-effects
Creon 25000 Capsules Active Ingredients / Generics: pancreatin Company: Abbott Healthcare Products Limited \| Document History Change to side-effects
Creon 40000 Capsules Active Ingredients / Generics: pancreatin Company: Abbott Healthcare Products Limited \| Document History Change to side-effects
Creon Micro Active Ingredients / Generics: pancreatin Company: Abbott Healthcare Products Limited \| Document History Change to side-effects
Engerix B 10 micrograms/0.5ml suspension for injection Active Ingredients / Generics: hepatitis b vaccine (rDNA) Company: GlaxoSmithKline UK \| Document History Change to date of revision Change to warnings or special precautions for use
Gyno-Pevaryl 1 Vaginal Pessary Active Ingredients / Generics: econazole nitrate Company: Janssen-Cilag Ltd \| Document History Change to section 4.5 - Interaction with other medicinal products and other forms of interaction Change to section 4.9 - Overdose Change to section 10 date of revision of the text
Gyno-Pevaryl 150 mg Vaginal Pessaries Active Ingredients / Generics: econazole nitrate Company: Janssen-Cilag Ltd \| Document History Change to section 4.5 - Interaction with other medicinal products and other forms of interaction Change to section 4.9 - Overdose Change to section 10 date of revision of the text
Gyno-Pevaryl Cream Active Ingredients / Generics: econazole nitrate Company: Janssen-Cilag Ltd \| Document History Change to section 4.5 - Interaction with other medicinal products and other forms of interaction Change to section 4.9 - Overdose Change to section 10 date of revision of the text
Latanoprost 50mcg/ml eye drops Active Ingredients / Generics: latanoprost Company: Beacon Pharmaceuticals New PIL for new product
Latanoprost/Timolol 50 micrograms/ml and 5 mg/ml eye drops, solution Active Ingredients / Generics: timolol maleate, latanoprost Company: Beacon Pharmaceuticals New PIL for new product
Methylprednisolone 1000 mg powder and solvent for solution for injection/infusion Active Ingredients / Generics: methylprednisolone sodium succinate Company: Beacon Pharmaceuticals New PIL for new product
Methylprednisolone 500 mg powder and solvent for solution for injection/infusion Active Ingredients / Generics: methylprednisolone sodium succinate Company: Beacon Pharmaceuticals New PIL for new product
Sertraline 50mg tablets Active Ingredients / Generics: sertraline hydrochloride Company: Aurobindo Pharma Ltd \| Document History Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
Stelara 45 mg solution for injection in pre-filled syringe Active Ingredients / Generics: ustekinumab Company: Janssen-Cilag Ltd \| Document History Change of contra-indications Change to side-effects
Stelara 45 mg solution for injection in pre-filled syringe Active Ingredients / Generics: ustekinumab Company: Janssen-Cilag 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 4.6 - 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
SUTENT 12.5mg, 25mg, 37.5mg and 50mg Hard Capsules Active Ingredients / Generics: sunitinib malate Company: Pfizer Limited \| Document History Correction of spelling/typing errors
Ticovac 0.25ml Junior Active Ingredients / Generics: tick borne encephalitis virus Company: MASTA Ltd \| Document History Change to section 6. 3 - Shelf Life
Versatis 5% Medicated Plaster Active Ingredients / Generics: lidocaine Company: Grunenthal Ltd \| Document History Change to how the medicine works Change to date of revision
Xylocaine 1% and 2% with Adrenaline Active Ingredients / Generics: lidocaine hydrochloride, adrenaline tartrate Company: AstraZeneca UK Limited \| Document History Improved Electronic Presentation
Xyzal 0.5 mg/ml oral solution Active Ingredients / Generics: levocetirizine dihydrochloride Company: UCB Pharma Limited \| Document History Change to section 4.1 - Therapeutic indications 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
Zofran Injection, Flexi-Amp Injection Active Ingredients / Generics: ondansetron hydrochloride dihydrate Company: GlaxoSmithKline UK \| Document History 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
Zofran Melt 4mg Active Ingredients / Generics: ondansetron Company: GlaxoSmithKline UK \| Document History 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
Zofran Melt 8mg Active Ingredients / Generics: ondansetron Company: GlaxoSmithKline UK \| Document History 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
Zofran Suppositories Active Ingredients / Generics: ondansetron Company: GlaxoSmithKline UK \| Document History 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
Zofran Syrup Active Ingredients / Generics: ondansetron hydrochloride dihydrate Company: GlaxoSmithKline UK \| Document History 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
Zofran Tablets 4mg Active Ingredients / Generics: ondansetron hydrochloride dihydrate Company: GlaxoSmithKline UK \| Document History 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
Zofran Tablets 8mg Active Ingredients / Generics: ondansetron hydrochloride dihydrate Company: GlaxoSmithKline UK \| Document History 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
26 January 2012 New 5, Updated 28, Retired 11, [Total 44]
Aldactide 50 and 25 Tablets Active Ingredients / Generics: spironolactone, hydroflumethiazide Company: Pharmacia Limited \| Document History Change to Marketing Authorisation Holder
Amaryl Active Ingredients / Generics: glimepiride Company: sanofi-aventis PIL Product / presentation discontinued
Amaryl Active Ingredients / Generics: glimepiride Company: sanofi-aventis SPC Product / presentation discontinued
Apidra 100 U/ml solution for injection in OptiClik cartridge Active Ingredients / Generics: insulin glulisine Company: sanofi-aventis PIL Product / presentation discontinued
Apidra 100 Units/ml solution for injection in a cartridge for OptiClik Active Ingredients / Generics: insulin glulisine Company: sanofi-aventis SPC Product / presentation discontinued
Care Decongestant Nasal Spray Active Ingredients / Generics: oxymetazoline hydrochloride Company: Thornton & Ross Ltd \| 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 Change to section 4.9 - Overdose
Chirocaine 7.5mg/ml solution for injection/concentrate for solution for infusion Active Ingredients / Generics: levobupivacaine hydrochloride Company: Abbott Laboratories Limited \| Document History Change to section 4.4 - Special warnings and precautions for Use Change to section 4.8 - Undesirable Effects Change to section 5.1 - Pharmacodynamic Properties Change to section 6. 5 - Nature and Contents of Container Change to section 10 date of revision of the text
Colomycin Tablets Active Ingredients / Generics: colistin sulphate Company: Forest Laboratories UK Limited \| Document History Change to section 4.2 - Posology and method of administration
Competact 15 mg/850 mg film-coated Tablets Active Ingredients / Generics: metformin hydrochloride, pioglitazone hydrochloride Company: Takeda UK Ltd \| Document History Correction of spelling/typing errors
Cordarone X 100, Cordarone X 200 Active Ingredients / Generics: amiodarone hydrochloride Company: sanofi-aventis PIL Product / presentation discontinued
Cordarone X 100, Cordarone X 200 Active Ingredients / Generics: amiodarone hydrochloride Company: sanofi-aventis SPC Product / presentation discontinued
Dermol 500 Lotion Active Ingredients / Generics: liquid paraffin, benzalkonium chloride, isopropyl myristate, chlorhexidine dihydrochloride Company: Dermal Laboratories Limited \| Document History Change to Further Information section Change to date of revision
Dermol Cream Active Ingredients / Generics: liquid paraffin, benzalkonium chloride, isopropyl myristate, chlorhexidine dihydrochloride Company: Dermal Laboratories Limited \| Document History Change to Further Information section Change to date of revision
Dicynene Active Ingredients / Generics: etamsylate Company: sanofi-aventis Licence Withdrawn
Dicynene 500 Tablets Active Ingredients / Generics: etamsylate Company: sanofi-aventis Licence Withdrawn
Diflucan 200 mg hard capsules Active Ingredients / Generics: fluconazole Company: Pfizer Limited New individual SPC (was previously included in combined SPC)
Diflucan 50mg hard capsules Active Ingredients / Generics: fluconazole Company: Pfizer Limited New individual SPC (was previously included in combined SPC)
Diflucan10 mg/ml powder for oral suspension Active Ingredients / Generics: fluconazole Company: Pfizer Limited New individual SPC (was previously included in combined SPC)
Diprivan 1% Active Ingredients / Generics: propofol Company: AstraZeneca UK Limited \| Document History Change to section 4.4 - Special warnings and precautions for Use 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 10 date of revision of the text
Diprivan 2% Active Ingredients / Generics: propofol Company: AstraZeneca UK Limited \| Document History Change to section 4.4 - Special warnings and precautions for Use 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 10 date of revision of the text
Doublebase Emollient Bath Additive Active Ingredients / Generics: liquid paraffin Company: Dermal Laboratories Limited \| Document History Change to Further Information section Change to date of revision
Doublebase Emollient Wash Gel Active Ingredients / Generics: liquid paraffin, isopropyl myristate Company: Dermal Laboratories Limited \| Document History Change to Further Information section Change to date of revision
Eloxatin 5 mg/ml concentrate for solution for infusion Active Ingredients / Generics: oxaliplatin Company: sanofi-aventis PIL Product / presentation discontinued
Eloxatin 5 mg/ml concentrate for solution for infusion Active Ingredients / Generics: oxaliplatin Company: sanofi-aventis SPC Product / presentation discontinued
Glucobay 100mg tablets Active Ingredients / Generics: acarbose Company: Bayer plc \| Document History Change to date of revision
Glucobay 50mg tablets Active Ingredients / Generics: acarbose Company: Bayer plc \| Document History Change to date of revision
Humira Pre-filled Pen, Pre-filled Syringe and Vial Active Ingredients / Generics: adalimumab Company: Abbott Laboratories Limited \| Document History Change to section 4.4 - Special warnings and precautions for Use Change to section 4.6 - Pregnancy and Lactation Change to section 10 date of revision of the text
Infanrix IPV Active Ingredients / Generics: poliomyelitis vaccine, diphtheria, tetanus and pertussis vaccine Company: GlaxoSmithKline UK \| Document History Change to section 4.4 - Special warnings and precautions for Use Change to section 10 date of revision of the text
Insuman Basal Optiset Active Ingredients / Generics: human insulin Company: sanofi-aventis PIL Product / presentation discontinued
Midazolam 1mg/ml, solution for injection Active Ingredients / Generics: midazolam hydrochloride Company: hameln pharmaceuticals ltd \| Document History Addition of joint PIL covering all presentations
Midazolam 2mg/ml, solution for injection Active Ingredients / Generics: midazolam hydrochloride Company: hameln pharmaceuticals ltd \| Document History Addition of joint PIL covering all presentations
Midazolam 5mg/ml, solution for injection Active Ingredients / Generics: midazolam hydrochloride Company: hameln pharmaceuticals ltd \| Document History Individual presentations superseded by joint PIL
NEULASTA with needle guard Active Ingredients / Generics: pegfilgrastim Company: Amgen Ltd \| Document History Change due to user-testing of patient information
Norvir 100mg film-coated tablets Active Ingredients / Generics: ritonavir Company: Abbott Laboratories Limited \| Document History Change to date of revision Change to side-effects
Norvir Oral Solution Active Ingredients / Generics: ritonavir Company: Abbott Laboratories Limited \| Document History Change to date of revision Change to side-effects
Otrivine Allergy Relief 0.1% Nasal Spray Active Ingredients / Generics: xylometazoline hydrochloride Company: Novartis Consumer Health New SPC for new product
Robitussin Chesty Cough with Congestion Active Ingredients / Generics: guaifenesin, pseudoephedrine hydrochloride Company: Pfizer Consumer Healthcare \| Document History Change to section 4.9 - Overdose
Sodium Fusidate 500mg for Intravenous Infusion Active Ingredients / Generics: sodium fusidate Company: Leo Laboratories Limited \| 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 side-effects Change to drug interactions Change to name of manufacturer
Tasigna 150mg Hard Capsules Active Ingredients / Generics: nilotinib hydrochloride monohydrate Company: Novartis Pharmaceuticals UK Ltd \| Document History Change to Further Information section
Tasigna 200 mg hard capsules Active Ingredients / Generics: nilotinib hydrochloride monohydrate Company: Novartis Pharmaceuticals UK Ltd \| Document History Change to Further Information section
Tramadol 50mg/ml Solution for Injection or Infusion Active Ingredients / Generics: tramadol hydrochloride Company: Beacon Pharmaceuticals \| Document History Change to section 4.4 - Special warnings and precautions for Use 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
Typherix Active Ingredients / Generics: typhoid vaccine Company: GlaxoSmithKline UK \| Document History Change to date of revision Change to warnings or special precautions for use
Voltarol Active 4% cutaneous Spray Active Ingredients / Generics: diclofenac sodium Company: Novartis Consumer Health New SPC for new product
Zydol 50mg Capsules Active Ingredients / Generics: tramadol hydrochloride Company: Grunenthal Ltd \| Document History Change to section 6. 4 - Special Precautions for Storage
25 January 2012 New 0, Updated 39, Retired 4, [Total 43]
ACWY Vax Vaccine Active Ingredients / Generics: acwy meningococcal polysaccharide Company: GlaxoSmithKline UK \| Document History Change to date of revision Change to warnings or special precautions for use
ACWY Vax Vaccine Active Ingredients / Generics: acwy meningococcal polysaccharide Company: GlaxoSmithKline UK \| Document History Change to section 4.4 - Special warnings and precautions for Use Change to section 10 date of revision of the text
Amikin Injection 100MG/2ML Active Ingredients / Generics: amikacin sulfate Company: Bristol-Myers Squibb Holdings Limited \| Document History Change/addition of instructions for reconstitution and/ or administration Change to warnings or special precautions for use Change to side-effects Change to information about pregnancy or lactation
Arzerra (acetate formulation) Active Ingredients / Generics: ofatumumab Company: GlaxoSmithKline UK \| Document History Change to section 4.4 - Special warnings and precautions for Use 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
Chirocaine 0.625mg/ml & 1.25mg/ml solution for infusion Active Ingredients / Generics: levobupivacaine hydrochloride Company: Abbott Laboratories Limited \| Document History Change to section 4.4 - Special warnings and precautions for Use Change to section 4.8 - Undesirable Effects Change to section 5.1 - Pharmacodynamic Properties Change to section 6. 5 - Nature and Contents of Container Change to section 10 date of revision of the text
Chirocaine 2.5mg/ml solution for injection/concentrate for solution for infusion Active Ingredients / Generics: levobupivacaine hydrochloride Company: Abbott Laboratories Limited \| Document History Change to section 4.4 - Special warnings and precautions for Use Change to section 4.8 - Undesirable Effects Change to section 5.1 - Pharmacodynamic Properties Change to section 6. 5 - Nature and Contents of Container Change to section 10 date of revision of the text
Chirocaine 5mg/ml solution for injection/concentrate for solution for infusion Active Ingredients / Generics: levobupivacaine hydrochloride Company: Abbott Laboratories Limited \| Document History Change to section 4.4 - Special warnings and precautions for Use Change to section 4.8 - Undesirable Effects Change to section 5.1 - Pharmacodynamic Properties Change to section 6. 5 - Nature and Contents of Container Change to section 10 date of revision of the text
Clenil Modulite 50, 100, 200, 250 micrograms inhaler Active Ingredients / Generics: beclometasone dipropionate Company: Chiesi Limited \| Document History Change to Further Information section Change to date of revision
Colomycin Tablets Active Ingredients / Generics: colistin sulphate Company: Forest Laboratories UK Limited \| Document History Addition of separate PILs covering individual presentations Change to dosage and administration
Depo-Provera 150mg/ml Injection Active Ingredients / Generics: medroxyprogesterone acetate Company: Pharmacia Limited \| Document History Change to date of revision Change to Marketing Authorisation Holder
Depo-Provera 150mg/ml Injection Active Ingredients / Generics: medroxyprogesterone acetate Company: Pharmacia Limited \| Document History 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
Diflucan 150 Capsules Active Ingredients / Generics: fluconazole Company: Pfizer Limited \| Document History Improved Electronic Presentation
Diflucan 150 Capsules Active Ingredients / Generics: fluconazole Company: Pfizer Limited \| Document History Correction of spelling/typing errors
Diflucan Caps 50mg, 200mg Active Ingredients / Generics: fluconazole Company: Pfizer Limited \| Document History Correction of spelling/typing errors
Diflucan Intravenous Infusion Active Ingredients / Generics: fluconazole Company: Pfizer Limited \| Document History Correction of spelling/typing errors
Diflucan Suspension Active Ingredients / Generics: fluconazole Company: Pfizer Limited \| Document History Correction of spelling/typing errors
Diprivan 1% Active Ingredients / Generics: propofol Company: AstraZeneca UK Limited \| Document History Change to date of revision Change to side-effects
Diprivan 2% Active Ingredients / Generics: propofol Company: AstraZeneca UK Limited \| Document History Change to date of revision Change to side-effects
Doxorubicin Hydrochloride 2 mg/ml solution for infusion (hameln) Active Ingredients / Generics: doxorubicin hydrochloride Company: hameln pharmaceuticals ltd PIL Product / presentation discontinued
Durogesic DTrans 12/25/50/75/100 mcg/hr Transdermal Patch Active Ingredients / Generics: fentanyl Company: Janssen-Cilag Ltd \| Document History Change to section 4.2 - Posology and method of administration Change to section 10 date of revision of the text
Engerix B 20 micrograms/1 ml Active Ingredients / Generics: hepatitis b vaccine (rDNA) Company: GlaxoSmithKline UK \| Document History Change to section 4.4 - Special warnings and precautions for Use Change to section 10 date of revision of the text
Engerix B 20 micrograms/1 ml Suspension for injection in pre-filled syringe Active Ingredients / Generics: hepatitis b vaccine (rDNA) Company: GlaxoSmithKline UK \| Document History Change to section 4.4 - Special warnings and precautions for Use Change to section 10 date of revision of the text
Engerix B 20 micrograms/1 ml Suspension for injection, Hepatitis B recombinant vaccine, adsorbed Active Ingredients / Generics: hepatitis b vaccine (rDNA) Company: GlaxoSmithKline UK \| Document History Change to date of revision Change to warnings or special precautions for use
Epirubicin hydrochloride 2mg/ml solution for injection or infusion (hameln) Active Ingredients / Generics: epirubicin hydrochloride Company: hameln pharmaceuticals ltd PIL Product / presentation discontinued
Glucobay 100 mg tablets Active Ingredients / Generics: acarbose Company: Bayer plc \| Document History 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 10 date of revision of the text
Glucobay 50mg tablets Active Ingredients / Generics: acarbose Company: Bayer plc \| Document History 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 10 date of revision of the text
Hc45 Hydrocortisone Cream Active Ingredients / Generics: hydrocortisone acetate Company: Reckitt Benckiser Healthcare (UK) Ltd \| Document History Change of licence holder
Hepatyrix Active Ingredients / Generics: hepatitis a vaccine, typhoid vaccine Company: GlaxoSmithKline UK \| Document History Change to section 4.4 - Special warnings and precautions for Use Change to section 10 date of revision of the text
Hepatyrix Active Ingredients / Generics: hepatitis a vaccine, typhoid vaccine Company: GlaxoSmithKline UK \| Document History Change to date of revision Change to warnings or special precautions for use
Infanrix-IPV Active Ingredients / Generics: poliomyelitis vaccine, diphtheria, tetanus and pertussis vaccine Company: GlaxoSmithKline UK \| Document History Change to date of revision Change to warnings or special precautions for use
Inovelon Tablets Active Ingredients / Generics: rufinamide Company: Eisai Ltd \| Document History Change to section 4.4 - Special warnings and precautions for Use Change to section 9 - Date of first Authorisation/renewal of the Authorisation Change to section 10 date of revision of the text
Modrenal Active Ingredients / Generics: trilostane Company: Genzyme Therapeutics Licence Withdrawn
Modrenal Active Ingredients / Generics: trilostane Company: Genzyme Therapeutics Licence Withdrawn
Ondansetron 2 mg/ml Solution for Injection Active Ingredients / Generics: ondansetron hydrochloride dihydrate Company: hameln pharmaceuticals ltd \| Document History Change to dosage and administration
Pinexel PR 400 micrograms Prolonged-Release Hard Capsules Active Ingredients / Generics: tamsulosin hydrochloride Company: Wockhardt UK Ltd \| Document History 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 6.1 - List of Excipients
Protium 40 mg i.v. Powder for Solution for Injection Active Ingredients / Generics: pantoprazole sodium sesquihydrate Company: Nycomed UK Ltd \| Document History Change to section 4.8 - Undesirable Effects
Tasigna 150mg Hard Capsules Active Ingredients / Generics: nilotinib hydrochloride monohydrate Company: Novartis Pharmaceuticals UK Ltd \| Document History Change to section 6. 5 - Nature and Contents of Container Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
Tasigna 200 mg hard capsules Active Ingredients / Generics: nilotinib hydrochloride monohydrate Company: Novartis Pharmaceuticals UK Ltd \| Document History Change to section 6. 5 - Nature and Contents of Container Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
Tramadol 50mg/ml Solution for Injection or Infusion Active Ingredients / Generics: tramadol hydrochloride Company: Beacon Pharmaceuticals \| Document History Change to date of revision Change to warnings or special precautions for use Change to side-effects Change to information about pregnancy or lactation Change to information about driving or using machinery
Trimethoprim Tablets 100mg, 200mg Active Ingredients / Generics: trimethoprim Company: Actavis UK Ltd \| Document History Change to side-effects
Typherix Active Ingredients / Generics: typhoid vaccine Company: GlaxoSmithKline UK \| Document History Change to section 4.4 - Special warnings and precautions for Use Change to section 10 date of revision of the text
XGEVA Active Ingredients / Generics: denosumab Company: Amgen Ltd \| Document History Change to section 6. 5 - Nature and Contents of Container
Zydol 50mg Capsules Active Ingredients / Generics: tramadol hydrochloride Company: Grunenthal Ltd \| Document History Change to storage instructions

27 January 2012

New 4, Updated 31, Retired 0, [Total 35]

Arythmol 150mg and 300mg Tablets

Active Ingredients / Generics: propafenone hydrochloride

Company: Abbott Laboratories 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 4.6 - Pregnancy and Lactation
Change to section 4.8 - Undesirable Effects
Change to section 4.9 - Overdose

Budenofalk 2mg/dose rectal foam

Active Ingredients / Generics: budesonide

Company: Dr. Falk Pharma UK Ltd | Document History

Change to section 4.4 - Special warnings and precautions for Use

Burinex 1mg Tablets

Active Ingredients / Generics: bumetanide

Company: Leo Laboratories Limited | Document History

Change to section 6. 3 - Shelf Life
Change to section 10 date of revision of the text

Burinex 5mg Tablets

Active Ingredients / Generics: bumetanide

Company: Leo Laboratories Limited | Document History

Change to section 6. 3 - Shelf Life
Change to section 10 date of revision of the text

Cipramil Drops 40 mg/ml

Active Ingredients / Generics: citalopram hydrochloride

Company: Lundbeck 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

Cipramil Drops 40 mg/ml

Active Ingredients / Generics: citalopram hydrochloride

Company: Lundbeck 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
Change to section 4.9 - Overdose
Change to section 5.1 - Pharmacodynamic Properties
Change to section 10 date of revision of the text

Cipramil Tablets

Active Ingredients / Generics: citalopram hydrobromide

Company: Lundbeck 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
Change to section 4.9 - Overdose
Change to section 5.1 - Pharmacodynamic Properties
Change to section 10 date of revision of the text

Cipramil Tablets

Active Ingredients / Generics: citalopram hydrobromide

Company: Lundbeck 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

Creon 10000 Capsules

Active Ingredients / Generics: pancreatin

Company: Abbott Healthcare Products Limited | Document History

Change to side-effects

Creon 25000 Capsules

Active Ingredients / Generics: pancreatin

Company: Abbott Healthcare Products Limited | Document History

Change to side-effects

Creon 40000 Capsules

Active Ingredients / Generics: pancreatin

Company: Abbott Healthcare Products Limited | Document History

Change to side-effects

Creon Micro

Active Ingredients / Generics: pancreatin

Company: Abbott Healthcare Products Limited | Document History

Change to side-effects

Engerix B 10 micrograms/0.5ml suspension for injection

Active Ingredients / Generics: hepatitis b vaccine (rDNA)

Company: GlaxoSmithKline UK | Document History

Change to date of revision
Change to warnings or special precautions for use

Gyno-Pevaryl 1 Vaginal Pessary

Active Ingredients / Generics: econazole nitrate

Company: Janssen-Cilag Ltd | Document History

Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Change to section 4.9 - Overdose
Change to section 10 date of revision of the text

Gyno-Pevaryl 150 mg Vaginal Pessaries

Active Ingredients / Generics: econazole nitrate

Company: Janssen-Cilag Ltd | Document History

Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Change to section 4.9 - Overdose
Change to section 10 date of revision of the text

Gyno-Pevaryl Cream

Active Ingredients / Generics: econazole nitrate

Company: Janssen-Cilag Ltd | Document History

Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Change to section 4.9 - Overdose
Change to section 10 date of revision of the text

Latanoprost 50mcg/ml eye drops

Active Ingredients / Generics: latanoprost

Company: Beacon Pharmaceuticals

New PIL for new product

Latanoprost/Timolol 50 micrograms/ml and 5 mg/ml eye drops, solution

Active Ingredients / Generics: timolol maleate, latanoprost

Company: Beacon Pharmaceuticals

New PIL for new product

Methylprednisolone 1000 mg powder and solvent for solution for injection/infusion

Active Ingredients / Generics: methylprednisolone sodium succinate

Company: Beacon Pharmaceuticals

New PIL for new product

Methylprednisolone 500 mg powder and solvent for solution for injection/infusion

Active Ingredients / Generics: methylprednisolone sodium succinate

Company: Beacon Pharmaceuticals

New PIL for new product

Sertraline 50mg tablets

Active Ingredients / Generics: sertraline hydrochloride

Company: Aurobindo Pharma Ltd | Document History

Change to section 8 - MARKETING AUTHORISATION NUMBER(S)

Stelara 45 mg solution for injection in pre-filled syringe

Active Ingredients / Generics: ustekinumab

Company: Janssen-Cilag Ltd | Document History

Change of contra-indications
Change to side-effects

Stelara 45 mg solution for injection in pre-filled syringe

Active Ingredients / Generics: ustekinumab

Company: Janssen-Cilag 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 4.6 - 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

SUTENT 12.5mg, 25mg, 37.5mg and 50mg Hard Capsules

Active Ingredients / Generics: sunitinib malate

Company: Pfizer Limited | Document History

Correction of spelling/typing errors

Ticovac 0.25ml Junior

Active Ingredients / Generics: tick borne encephalitis virus

Company: MASTA Ltd | Document History

Change to section 6. 3 - Shelf Life

Versatis 5% Medicated Plaster

Active Ingredients / Generics: lidocaine

Company: Grunenthal Ltd | Document History

Change to how the medicine works
Change to date of revision

Xylocaine 1% and 2% with Adrenaline

Active Ingredients / Generics: lidocaine hydrochloride, adrenaline tartrate

Company: AstraZeneca UK Limited | Document History

Improved Electronic Presentation

Xyzal 0.5 mg/ml oral solution

Active Ingredients / Generics: levocetirizine dihydrochloride

Company: UCB Pharma Limited | Document History

Change to section 4.1 - Therapeutic indications
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

Zofran Injection, Flexi-Amp Injection

Active Ingredients / Generics: ondansetron hydrochloride dihydrate

Company: GlaxoSmithKline UK | Document History

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

Zofran Melt 4mg

Active Ingredients / Generics: ondansetron

Company: GlaxoSmithKline UK | Document History

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

Zofran Melt 8mg

Active Ingredients / Generics: ondansetron

Company: GlaxoSmithKline UK | Document History

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

Zofran Suppositories

Active Ingredients / Generics: ondansetron

Company: GlaxoSmithKline UK | Document History

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

Zofran Syrup

Active Ingredients / Generics: ondansetron hydrochloride dihydrate

Company: GlaxoSmithKline UK | Document History

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

Zofran Tablets 4mg

Active Ingredients / Generics: ondansetron hydrochloride dihydrate

Company: GlaxoSmithKline UK | Document History

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

Zofran Tablets 8mg

Active Ingredients / Generics: ondansetron hydrochloride dihydrate

Company: GlaxoSmithKline UK | Document History

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

26 January 2012

New 5, Updated 28, Retired 11, [Total 44]

Aldactide 50 and 25 Tablets

Active Ingredients / Generics: spironolactone, hydroflumethiazide

Company: Pharmacia Limited | Document History

Change to Marketing Authorisation Holder

Amaryl

Active Ingredients / Generics: glimepiride

Company: sanofi-aventis

PIL Product / presentation discontinued

Amaryl

Active Ingredients / Generics: glimepiride

Company: sanofi-aventis

SPC Product / presentation discontinued

Apidra 100 U/ml solution for injection in OptiClik cartridge

Active Ingredients / Generics: insulin glulisine

Company: sanofi-aventis

PIL Product / presentation discontinued

Apidra 100 Units/ml solution for injection in a cartridge for OptiClik

Active Ingredients / Generics: insulin glulisine

Company: sanofi-aventis

SPC Product / presentation discontinued

Care Decongestant Nasal Spray

Active Ingredients / Generics: oxymetazoline hydrochloride

Company: Thornton & Ross Ltd | 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
Change to section 4.9 - Overdose

Chirocaine 7.5mg/ml solution for injection/concentrate for solution for infusion

Active Ingredients / Generics: levobupivacaine hydrochloride

Company: Abbott Laboratories Limited | Document History

Change to section 4.4 - Special warnings and precautions for Use
Change to section 4.8 - Undesirable Effects
Change to section 5.1 - Pharmacodynamic Properties
Change to section 6. 5 - Nature and Contents of Container
Change to section 10 date of revision of the text

Colomycin Tablets

Active Ingredients / Generics: colistin sulphate

Company: Forest Laboratories UK Limited | Document History

Change to section 4.2 - Posology and method of administration

Competact 15 mg/850 mg film-coated Tablets

Active Ingredients / Generics: metformin hydrochloride, pioglitazone hydrochloride

Company: Takeda UK Ltd | Document History

Correction of spelling/typing errors

Cordarone X 100, Cordarone X 200

Active Ingredients / Generics: amiodarone hydrochloride

Company: sanofi-aventis

PIL Product / presentation discontinued

Cordarone X 100, Cordarone X 200

Active Ingredients / Generics: amiodarone hydrochloride

Company: sanofi-aventis

SPC Product / presentation discontinued

Dermol 500 Lotion

Active Ingredients / Generics: liquid paraffin, benzalkonium chloride, isopropyl myristate, chlorhexidine dihydrochloride

Company: Dermal Laboratories Limited | Document History

Change to Further Information section
Change to date of revision

Dermol Cream

Active Ingredients / Generics: liquid paraffin, benzalkonium chloride, isopropyl myristate, chlorhexidine dihydrochloride

Company: Dermal Laboratories Limited | Document History

Change to Further Information section
Change to date of revision

Dicynene

Active Ingredients / Generics: etamsylate

Company: sanofi-aventis

Licence Withdrawn

Dicynene 500 Tablets

Active Ingredients / Generics: etamsylate

Company: sanofi-aventis

Licence Withdrawn

Diflucan 200 mg hard capsules

Active Ingredients / Generics: fluconazole

Company: Pfizer Limited

New individual SPC (was previously included in combined SPC)

Diflucan 50mg hard capsules

Active Ingredients / Generics: fluconazole

Company: Pfizer Limited

New individual SPC (was previously included in combined SPC)

Diflucan10 mg/ml powder for oral suspension

Active Ingredients / Generics: fluconazole

Company: Pfizer Limited

New individual SPC (was previously included in combined SPC)

Diprivan 1%

Active Ingredients / Generics: propofol

Company: AstraZeneca UK Limited | Document History

Change to section 4.4 - Special warnings and precautions for Use
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 10 date of revision of the text

Diprivan 2%

Active Ingredients / Generics: propofol

Company: AstraZeneca UK Limited | Document History

Change to section 4.4 - Special warnings and precautions for Use
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 10 date of revision of the text

Doublebase Emollient Bath Additive

Active Ingredients / Generics: liquid paraffin

Company: Dermal Laboratories Limited | Document History

Change to Further Information section
Change to date of revision

Doublebase Emollient Wash Gel

Active Ingredients / Generics: liquid paraffin, isopropyl myristate

Company: Dermal Laboratories Limited | Document History

Change to Further Information section
Change to date of revision

Eloxatin 5 mg/ml concentrate for solution for infusion

Active Ingredients / Generics: oxaliplatin

Company: sanofi-aventis

PIL Product / presentation discontinued

Eloxatin 5 mg/ml concentrate for solution for infusion

Active Ingredients / Generics: oxaliplatin

Company: sanofi-aventis

SPC Product / presentation discontinued

Glucobay 100mg tablets

Active Ingredients / Generics: acarbose

Company: Bayer plc | Document History

Change to date of revision

Glucobay 50mg tablets

Active Ingredients / Generics: acarbose

Company: Bayer plc | Document History

Change to date of revision

Humira Pre-filled Pen, Pre-filled Syringe and Vial

Active Ingredients / Generics: adalimumab

Company: Abbott Laboratories Limited | Document History

Change to section 4.4 - Special warnings and precautions for Use
Change to section 4.6 - Pregnancy and Lactation
Change to section 10 date of revision of the text

Infanrix IPV

Active Ingredients / Generics: poliomyelitis vaccine, diphtheria, tetanus and pertussis vaccine

Company: GlaxoSmithKline UK | Document History

Change to section 4.4 - Special warnings and precautions for Use
Change to section 10 date of revision of the text

Insuman Basal Optiset

Active Ingredients / Generics: human insulin

Company: sanofi-aventis

PIL Product / presentation discontinued

Midazolam 1mg/ml, solution for injection

Active Ingredients / Generics: midazolam hydrochloride

Company: hameln pharmaceuticals ltd | Document History

Addition of joint PIL covering all presentations

Midazolam 2mg/ml, solution for injection

Active Ingredients / Generics: midazolam hydrochloride

Company: hameln pharmaceuticals ltd | Document History

Addition of joint PIL covering all presentations

Midazolam 5mg/ml, solution for injection

Active Ingredients / Generics: midazolam hydrochloride

Company: hameln pharmaceuticals ltd | Document History

Individual presentations superseded by joint PIL

NEULASTA with needle guard

Active Ingredients / Generics: pegfilgrastim

Company: Amgen Ltd | Document History

Change due to user-testing of patient information

Norvir 100mg film-coated tablets

Active Ingredients / Generics: ritonavir

Company: Abbott Laboratories Limited | Document History

Change to date of revision
Change to side-effects

Norvir Oral Solution

Active Ingredients / Generics: ritonavir

Company: Abbott Laboratories Limited | Document History

Change to date of revision
Change to side-effects

Otrivine Allergy Relief 0.1% Nasal Spray

Active Ingredients / Generics: xylometazoline hydrochloride

Company: Novartis Consumer Health

New SPC for new product

Robitussin Chesty Cough with Congestion

Active Ingredients / Generics: guaifenesin, pseudoephedrine hydrochloride

Company: Pfizer Consumer Healthcare | Document History

Change to section 4.9 - Overdose

Sodium Fusidate 500mg for Intravenous Infusion

Active Ingredients / Generics: sodium fusidate

Company: Leo Laboratories Limited | 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 side-effects
Change to drug interactions
Change to name of manufacturer

Tasigna 150mg Hard Capsules

Active Ingredients / Generics: nilotinib hydrochloride monohydrate

Company: Novartis Pharmaceuticals UK Ltd | Document History

Change to Further Information section

Tasigna 200 mg hard capsules

Active Ingredients / Generics: nilotinib hydrochloride monohydrate

Company: Novartis Pharmaceuticals UK Ltd | Document History

Change to Further Information section

Tramadol 50mg/ml Solution for Injection or Infusion

Active Ingredients / Generics: tramadol hydrochloride

Company: Beacon Pharmaceuticals | Document History

Change to section 4.4 - Special warnings and precautions for Use
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

Typherix

Active Ingredients / Generics: typhoid vaccine

Company: GlaxoSmithKline UK | Document History

Change to date of revision
Change to warnings or special precautions for use

Voltarol Active 4% cutaneous Spray

Active Ingredients / Generics: diclofenac sodium

Company: Novartis Consumer Health

New SPC for new product

Zydol 50mg Capsules

Active Ingredients / Generics: tramadol hydrochloride

Company: Grunenthal Ltd | Document History

Change to section 6. 4 - Special Precautions for Storage

25 January 2012

New 0, Updated 39, Retired 4, [Total 43]

ACWY Vax Vaccine

Active Ingredients / Generics: acwy meningococcal polysaccharide

Company: GlaxoSmithKline UK | Document History

Change to date of revision
Change to warnings or special precautions for use

ACWY Vax Vaccine

Active Ingredients / Generics: acwy meningococcal polysaccharide

Company: GlaxoSmithKline UK | Document History

Change to section 4.4 - Special warnings and precautions for Use
Change to section 10 date of revision of the text

Amikin Injection 100MG/2ML

Active Ingredients / Generics: amikacin sulfate

Company: Bristol-Myers Squibb Holdings Limited | Document History

Change/addition of instructions for reconstitution and/ or administration
Change to warnings or special precautions for use
Change to side-effects
Change to information about pregnancy or lactation

Arzerra (acetate formulation)

Active Ingredients / Generics: ofatumumab

Company: GlaxoSmithKline UK | Document History

Change to section 4.4 - Special warnings and precautions for Use
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

Chirocaine 0.625mg/ml & 1.25mg/ml solution for infusion

Active Ingredients / Generics: levobupivacaine hydrochloride

Company: Abbott Laboratories Limited | Document History

Change to section 4.4 - Special warnings and precautions for Use
Change to section 4.8 - Undesirable Effects
Change to section 5.1 - Pharmacodynamic Properties
Change to section 6. 5 - Nature and Contents of Container
Change to section 10 date of revision of the text

Chirocaine 2.5mg/ml solution for injection/concentrate for solution for infusion

Active Ingredients / Generics: levobupivacaine hydrochloride

Company: Abbott Laboratories Limited | Document History

Change to section 4.4 - Special warnings and precautions for Use
Change to section 4.8 - Undesirable Effects
Change to section 5.1 - Pharmacodynamic Properties
Change to section 6. 5 - Nature and Contents of Container
Change to section 10 date of revision of the text

Chirocaine 5mg/ml solution for injection/concentrate for solution for infusion

Active Ingredients / Generics: levobupivacaine hydrochloride

Company: Abbott Laboratories Limited | Document History

Change to section 4.4 - Special warnings and precautions for Use
Change to section 4.8 - Undesirable Effects
Change to section 5.1 - Pharmacodynamic Properties
Change to section 6. 5 - Nature and Contents of Container
Change to section 10 date of revision of the text

Clenil Modulite 50, 100, 200, 250 micrograms inhaler

Active Ingredients / Generics: beclometasone dipropionate

Company: Chiesi Limited | Document History

Change to Further Information section
Change to date of revision

Colomycin Tablets

Active Ingredients / Generics: colistin sulphate

Company: Forest Laboratories UK Limited | Document History

Addition of separate PILs covering individual presentations
Change to dosage and administration

Depo-Provera 150mg/ml Injection

Active Ingredients / Generics: medroxyprogesterone acetate

Company: Pharmacia Limited | Document History

Change to date of revision
Change to Marketing Authorisation Holder

Depo-Provera 150mg/ml Injection

Active Ingredients / Generics: medroxyprogesterone acetate

Company: Pharmacia Limited | Document History

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

Diflucan 150 Capsules

Active Ingredients / Generics: fluconazole

Company: Pfizer Limited | Document History

Improved Electronic Presentation

Diflucan 150 Capsules

Active Ingredients / Generics: fluconazole

Company: Pfizer Limited | Document History

Correction of spelling/typing errors

Diflucan Caps 50mg, 200mg

Active Ingredients / Generics: fluconazole

Company: Pfizer Limited | Document History

Correction of spelling/typing errors

Diflucan Intravenous Infusion

Active Ingredients / Generics: fluconazole

Company: Pfizer Limited | Document History

Correction of spelling/typing errors

Diflucan Suspension

Active Ingredients / Generics: fluconazole

Company: Pfizer Limited | Document History

Correction of spelling/typing errors

Diprivan 1%

Active Ingredients / Generics: propofol

Company: AstraZeneca UK Limited | Document History

Change to date of revision
Change to side-effects

Diprivan 2%

Active Ingredients / Generics: propofol

Company: AstraZeneca UK Limited | Document History

Change to date of revision
Change to side-effects

Doxorubicin Hydrochloride 2 mg/ml solution for infusion (hameln)

Active Ingredients / Generics: doxorubicin hydrochloride

Company: hameln pharmaceuticals ltd

PIL Product / presentation discontinued

Durogesic DTrans 12/25/50/75/100 mcg/hr Transdermal Patch

Active Ingredients / Generics: fentanyl

Company: Janssen-Cilag Ltd | Document History

Change to section 4.2 - Posology and method of administration
Change to section 10 date of revision of the text

Engerix B 20 micrograms/1 ml

Active Ingredients / Generics: hepatitis b vaccine (rDNA)

Company: GlaxoSmithKline UK | Document History

Change to section 4.4 - Special warnings and precautions for Use
Change to section 10 date of revision of the text

Engerix B 20 micrograms/1 ml Suspension for injection in pre-filled syringe

Active Ingredients / Generics: hepatitis b vaccine (rDNA)

Company: GlaxoSmithKline UK | Document History

Change to section 4.4 - Special warnings and precautions for Use
Change to section 10 date of revision of the text

Engerix B 20 micrograms/1 ml Suspension for injection, Hepatitis B recombinant vaccine, adsorbed

Active Ingredients / Generics: hepatitis b vaccine (rDNA)

Company: GlaxoSmithKline UK | Document History

Change to date of revision
Change to warnings or special precautions for use

Epirubicin hydrochloride 2mg/ml solution for injection or infusion (hameln)

Active Ingredients / Generics: epirubicin hydrochloride

Company: hameln pharmaceuticals ltd

PIL Product / presentation discontinued

Glucobay 100 mg tablets

Active Ingredients / Generics: acarbose

Company: Bayer plc | Document History

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 10 date of revision of the text

Glucobay 50mg tablets

Active Ingredients / Generics: acarbose

Company: Bayer plc | Document History

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 10 date of revision of the text

Hc45 Hydrocortisone Cream

Active Ingredients / Generics: hydrocortisone acetate

Company: Reckitt Benckiser Healthcare (UK) Ltd | Document History