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Latest medicine updates

105 updates found

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MEDICINE NAME

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STATUS

SPC
clotrimazole
Updated 21-Nov-17
Updated
  • Change to section 1 - Name of the medicinal product
  • Change to section 4.4 - Special warnings and precautions for use
SPC
Carvedilol 3.125 mg film-coated tablets
carvedilol
Retired 21-Nov-17
Amneal Pharma Europe Limited
Retired
  • Submitted in error
SPC
Carvedilol 6.25 mg film-coated tablets
carvedilol
Retired 21-Nov-17
Amneal Pharma Europe Limited
Retired
  • Submitted in error
SPC
Carvedilol 12.5 mg film-coated tablets
carvedilol
Retired 21-Nov-17
Amneal Pharma Europe Limited
Retired
  • Submitted in error
SPC
Carvedilol 25 mg film-coated tablets
carvedilol
Retired 21-Nov-17
Amneal Pharma Europe Limited
Retired
  • Submitted in error
SPC
Clopidogrel 75 mg film-coated tablets
clopidogrel bisulfate
Retired 21-Nov-17
Amneal Pharma Europe Limited
Retired
  • Submitted in error
SPC
Bundisarin XL 10 mg prolonged release tablets
alfuzosin hydrochloride
Retired 21-Nov-17
Amneal Pharma Europe Limited
Retired
  • Submitted in error
Pil
telmisartan
Updated 21-Nov-17
Updated
  • Improved presentation of PIL
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors
  • Change to section 3 - how to take/use
  • Change to other sources of information section
  • Change to section 4 - how to report a side effect
SPC
flucytosine
Updated 21-Nov-17
Updated
  • Change to section 6.5 - Nature and contents of container
Pil
telmisartan
Updated 21-Nov-17
Updated
  • Improved presentation of PIL
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors
  • Change to section 3 - how to take/use
  • Change to other sources of information section
  • Change to section 4 - how to report a side effect
Pil
trastuzumab
Updated 21-Nov-17
Updated
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
Pil
trastuzumab
Updated 21-Nov-17
Updated
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
Pil
azithromycin
Updated 21-Nov-17
Updated
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
Pil
telmisartan
Updated 21-Nov-17
Updated
  • Improved presentation of PIL
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors
  • Change to section 3 - dose and frequency
  • Change to other sources of information section
  • Change to section 4 - how to report a side effect
SPC
trazodone hydrochloride
Updated 21-Nov-17
New
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
Pil
azithromycin
Updated 21-Nov-17
Updated
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
SPC
bendamustine hydrochloride
Updated 21-Nov-17
New
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
SPC
efavirenz
Updated 21-Nov-17
New
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
SPC
lamivudine
Updated 21-Nov-17
New
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
SPC
aripiprazole
Updated 21-Nov-17
New
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
SPC
aripiprazole
Updated 21-Nov-17
New
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
SPC
aripiprazole
Updated 21-Nov-17
New
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
SPC
aripiprazole
Updated 21-Nov-17
New
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
SPC
moroctocog alfa
Updated 21-Nov-17
Updated
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 4.8 - Undesirable effects - how to report a side effect
SPC
Zytiga 250 mg tablets
abiraterone acetate
Retired 21-Nov-17
Janssen-Cilag Ltd
Retired
  • Product/presentation currently not marketed
Pil
cladribine
Updated 21-Nov-17
Updated
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision
Pil
insulin degludec
Updated 21-Nov-17
Updated
  • Change to section 3 - how to take/use
Pil
amlodipine besilate
Updated 21-Nov-17
Updated
  • Change to section 2 - driving and using machines
  • Change to section 1 - what the product is used for
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 2 - pregnancy, breast feeding and fertility
Pil
insulin degludec
Updated 21-Nov-17
Updated
  • Change to section 3 - how to take/use
Pil
paracetamol
Updated 21-Nov-17
Updated
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 5 - how to store or dispose
  • Change to section 2 - excipient warnings
Pil
guselkumab
Updated 21-Nov-17
New
  • New PIL for new product
SPC
abiraterone acetate
Updated 21-Nov-17
Updated
  • 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects - how to report a side effect
Pil
insulin degludec
Updated 21-Nov-17
Updated
  • Change to section 3 - how to take/use
Pil
fludarabine phosphate
Updated 21-Nov-17
Updated
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - how to take/use
  • Change to section 1 - what the product is
SPC
guselkumab
Updated 21-Nov-17
New
  • New SPC for new product
SPC
buprenorphine
Updated 21-Nov-17
Updated
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
SPC
buprenorphine
Updated 21-Nov-17
Updated
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
SPC
buprenorphine
Updated 21-Nov-17
Updated
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
SPC
methotrexate
Updated 21-Nov-17
Updated
  • Change to section 1 - Name of the medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects - how to report a side effect
SPC
topotecan hydrochloride
Updated 21-Nov-17
Updated
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic 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 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects - how to report a side effect
SPC
topotecan hydrochloride
Updated 21-Nov-17
Updated
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic 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 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
Pil
paracetamol, pseudoephedrine hydrochloride
Updated 21-Nov-17
Updated
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - what you need to know - contraindications
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 5 - how to store or dispose
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - how to take/use
  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
SPC
paracetamol, phenylephrine hydrochloride
Updated 21-Nov-17
Updated
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
SPC
C1-esterase inhibitor, human
Updated 21-Nov-17
Updated
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
SPC
C1-esterase inhibitor, human
Updated 21-Nov-17
Updated
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
Pil
prilocaine, lidocaine
Updated 21-Nov-17
Updated
  • Change to section 6 - date of revision
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer
Pil
prilocaine, lidocaine
Updated 21-Nov-17
Updated
  • Change to section 6 - date of revision
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer
SPC
methotrexate
Updated 21-Nov-17
Updated
  • Change to section 1 - Name of the medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects - how to report a side effect
SPC
cefalexin
Updated 21-Nov-17
Updated
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
Pil
liraglutide, insulin degludec
Updated 21-Nov-17
Updated
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision
  • Change to section 3 - how to take/use

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