Document information 02/09/2010 15:22
Current documents
SPC 4122
PIL 3493
Total: 7615
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Updated: 1443
New: 511

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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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Document Type:
PIL SPC
Status:  
New Update Retired
02 September 2010
New 4, Updated 36, Retired 0, [Total 40]
Active Ingredients / Generics: influenza vaccine (surface antigen, inactivated)
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 10 date of revision of the text
Active Ingredients / Generics: paracetamol, caffeine, phenylephrine hydrochloride
  • 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 10 date of revision of the text
Active Ingredients / Generics: paracetamol, phenylephrine hydrochloride, guaifenesin
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
Active Ingredients / Generics: paracetamol, phenylephrine hydrochloride, guaifenesin
  • 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 4.7 - 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
Active Ingredients / Generics: paracetamol, phenylephrine hydrochloride, guaifenesin
  • 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 10 date of revision of the text
Active Ingredients / Generics: paracetamol, phenylephrine hydrochloride, guaifenesin
  • 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 10 date of revision of the text
Active Ingredients / Generics: paracetamol, phenylephrine hydrochloride, ascorbic acid (vitamin c)
  • 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 10 date of revision of the text
Active Ingredients / Generics: paracetamol, phenylephrine hydrochloride, ascorbic acid (vitamin c)
  • 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 10 date of revision of the text
Active Ingredients / Generics: paracetamol, caffeine, phenylephrine hydrochloride
  • 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 10 date of revision of the text
Active Ingredients / Generics: paracetamol, phenylephrine hydrochloride, ascorbic acid (vitamin c)
  • 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 10 date of revision of the text
Active Ingredients / Generics: paracetamol, caffeine, phenylephrine hydrochloride
  • 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 10 date of revision of the text
Active Ingredients / Generics: paracetamol, phenylephrine hydrochloride, ascorbic acid (vitamin c)
  • 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 10 date of revision of the text
Active Ingredients / Generics: paracetamol, caffeine, phenylephrine hydrochloride
  • 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 10 date of revision of the text
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 10 date of revision of the text
Active Ingredients / Generics: calcium carbonate
  • Change to side-effects
  • Change to drug interactions
Active Ingredients / Generics: calcium carbonate, colecalciferol (vitamin d3)
  • Change to date of revision
  • Change to side-effects
  • Change to drug interactions
Active Ingredients / Generics: calcium carbonate, colecalciferol (vitamin d3)
  • Change to side-effects
  • Change to drug interactions
Active Ingredients / Generics: calcium carbonate
  • Change to date of revision
  • Change to side-effects
  • Change to drug interactions
Active Ingredients / Generics: captopril
  • Change to section 4.9 - Overdose
Active Ingredients / Generics: miconazole
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Active Ingredients / Generics: dihydrocodeine tartrate
Company: Goldshield plc
  • New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
Active Ingredients / Generics: aspirin
  • Change to section 4.3 - Contraindications
  • 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
Active Ingredients / Generics: lactulose
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 5.3 - Preclinical Safety Data
Active Ingredients / Generics: influenza vaccine (surface antigen, inactivated)
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 10 date of revision of the text
Active Ingredients / Generics: furosemide
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
Active Ingredients / Generics: human papillomavirus vaccine
  • Change to, or new, use for medicine
Active Ingredients / Generics: haloperidol
  • 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
Active Ingredients / Generics: octocog alfa
  • 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 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - 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 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Active Ingredients / Generics: influenza vaccine (split virion, inactivated)
  • New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text
Active Ingredients / Generics: metoclopramide hydrochloride
Company: Goldshield plc
  • New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
Active Ingredients / Generics: sorafenib tosilate
  • Change to section 2 - Qualitative and quantitative composition
  • 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 5.2 - Pharmacokinetic Properties
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
Active Ingredients / Generics: ondansetron hydrochloride dihydrate
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
Active Ingredients / Generics: ondansetron hydrochloride dihydrate
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
Active Ingredients / Generics: influenza vaccine (split virion, inactivated)
  • Correction of spelling/typing errors
Active Ingredients / Generics: diltiazem hydrochloride
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
Active Ingredients / Generics: paracetamol, caffeine, codeine phosphate hemihydrate
  • Change to section 6.1 - List of Excipients
  • Change to section 10 date of revision of the text
Active Ingredients / Generics: erlotinib hydrochloride
  • Change to section 6. 3 - Shelf Life
  • Change to section 10 date of revision of the text
Active Ingredients / Generics: warfarin sodium
  • Change to date of revision
  • Change of manufacturer
  • Change of contra-indications
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to name of manufacturer
Active Ingredients / Generics: cefuroxime sodium
  • Change to date of revision
  • Change to warnings or special precautions for use
  • Change due to user-testing of patient information
01 September 2010
New 0, Updated 31, Retired 0, [Total 31]
Active Ingredients / Generics: terbutaline sulphate
  • Correction of spelling/typing errors
Active Ingredients / Generics: calcium carbonate
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
Active Ingredients / Generics: calcium carbonate, colecalciferol (vitamin d3)
  • 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
Active Ingredients / Generics: calcium carbonate, colecalciferol (vitamin d3)
  • 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
Active Ingredients / Generics: calcium carbonate
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
Active Ingredients / Generics: clomifene citrate
  • Change to side-effects
Active Ingredients / Generics: clomifene citrate
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
Active Ingredients / Generics: miconazole
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Active Ingredients / Generics: daunorubicin hydrochloride
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
Active Ingredients / Generics: daunorubicin hydrochloride
  • 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 10 date of revision of the text
  • 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 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 date of revision of the text
Active Ingredients / Generics: human papillomavirus vaccine
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 5.1 - Pharmacodynamic Properties
Active Ingredients / Generics: lamivudine, abacavir sulfate
  • Change to Marketing Authorisation Holder
  • Change to manufacturer contact details
Active Ingredients / Generics: ethinylestradiol, norethisterone acetate
  • Change to section 4.4 - Special warnings and precautions for Use
Active Ingredients / Generics: ethinylestradiol, norethisterone acetate
  • Change to section 4.4 - Special warnings and precautions for Use
Active Ingredients / Generics: sorafenib tosilate
  • Change to date of revision
  • Change to warnings or special precautions for use
  • Change of contra-indications
  • Change to side-effects, Extra statutory information
Active Ingredients / Generics: hydrocortisone, lidocaine hydrochloride
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Active Ingredients / Generics: lithium carbonate
  • Change to section 5.2 - Pharmacokinetic Properties
Active Ingredients / Generics: lithium citrate
  • Change to section 5.2 - Pharmacokinetic Properties
Active Ingredients / Generics: prucalopride succinate
  • Change to Further Information section
  • Change to date of revision
  • Change to manufacturer contact details
Active Ingredients / Generics: prucalopride succinate
  • Change to section 6. 5 - Nature and Contents of Container
  • 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
Active Ingredients / Generics: prucalopride succinate
  • Change to section 6. 5 - Nature and Contents of Container
  • 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
Active Ingredients / Generics: prednisolone hexanoate, cinchocaine hydrochloride
  • Removal/change of distributor
Active Ingredients / Generics: prednisolone hexanoate, cinchocaine hydrochloride
  • Removal/change of distributor
Active Ingredients / Generics: azelaic acid
  • Removal/change of distributor
Active Ingredients / Generics: No Active Ingredients
  • Removal/change of distributor
Active Ingredients / Generics: cilazapril monohydrate
  • 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 5.3 - Preclinical Safety Data
Active Ingredients / Generics: lamivudine
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Active Ingredients / Generics: lamivudine
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
31 August 2010
New 5, Updated 22, Retired 0, [Total 27]
Active Ingredients / Generics: erythromycin, tretinoin
Company: Almirall Limited
  • New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
Active Ingredients / Generics: ciclesonide
  • Improved Electronic Presentation
Active Ingredients / Generics: captopril
  • Change to section 4.9 - Overdose
Active Ingredients / Generics: captopril
  • Change to section 4.9 - Overdose
Active Ingredients / Generics: podophyllotoxin
  • Improved Electronic Presentation
Active Ingredients / Generics: tacalcitol monohydrate
  • Change to Marketing Authorisation Holder
  • 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 of manufacturer
Active Ingredients / Generics: nitrofurantoin
Company: Goldshield plc
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
Active Ingredients / Generics: nitrofurantoin
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
Active Ingredients / Generics: hydroxycarbamide
  • Change due to user-testing of patient information
  • Change to name of manufacturer
Active Ingredients / Generics: fentanyl citrate
  • Improved Electronic Presentation
Active Ingredients / Generics: influenza vaccine
  • Change to section 2 - Qualitative and quantitative composition
Active Ingredients / Generics: ethinylestradiol, norethisterone acetate
  • Change to date of revision
  • Change to warnings or special precautions for use
Active Ingredients / Generics: nitrofurantoin
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
Active Ingredients / Generics: nitrofurantoin
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
Active Ingredients / Generics: nitrofurantoin
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
Active Ingredients / Generics: fentanyl
  • Improved Electronic Presentation
Active Ingredients / Generics: pantoprazole sodium sesquihydrate
  • Improved Electronic Presentation
Active Ingredients / Generics: pantoprazole sodium sesquihydrate
  • Improved Electronic Presentation
Active Ingredients / Generics: phenindione
Company: Goldshield plc
  • New SPC for new product
Active Ingredients / Generics: phenindione
Company: Goldshield plc
  • New SPC for new product
Active Ingredients / Generics: procarbazine hydrochloride
  • 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
Active Ingredients / Generics: pantoprazole sodium
  • Improved Electronic Presentation
Active Ingredients / Generics: triamterene
Company: Goldshield plc
  • New PIL for eMC ie a PIL for an existing product but one that is new to the eMC
Active Ingredients / Generics: lapatinib ditosylate monohydrate
  • Improved Electronic Presentation
Active Ingredients / Generics: etoposide
  • Change due to user-testing of patient information
  • Change to name of manufacturer