Last Updated on eMC 11-07-2018 View medicine  | Pfizer Limited Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

Date of revision of text on the SPC:01-07-2018

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

The SPC has been updated as follows: Mucositis has been replaced with mucosal inflammation throughout the SPC in sections 4.4 & 4.9. Section 4.8 has been updated as per CDS to bring as much consistency as possible across EU national labels, to introduce Medical Dictionary for Regulatory Activities (MedDRA) 19.0 terminology into labels where it does not currently exist and to update frequencies for existing ADRs where applicable or deemed appropriate by the Health Authority.

Reasons for adding or updating:

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)

Date of revision of text on the SPC:01-09-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The SPC has been updated as follows:

Section 7: Change of marketing authorization holder from Pharmacia Limited to Pfizer Limited

Section 8: Change of marketing authorization number from PL 00032/0275 to PL 00057/1023

Reasons for adding or updating:

  • 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 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling

Date of revision of text on the SPC:01-01-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The SPC has been updated as follows:

 

1       Name of the medicinal product

Section updated in line with QRD Version 9

2       Qualitative and quantitative composition

Section updated in line with QRD Version 9

4.2       Posology and method of administration

Section updated in line with QRD Version 9

4.3.     Contraindications

Section updated in line with QRD Version 9

4.4.     Special warnings and precautions for use

Section updated in line with CDS on the half-life of trastuzumab and effect on cardiac function. Section on excipients relating to the powder for solution presentation has been taken off as this statement was added to the SPC in error.

4.5. Interaction with other medicinal products and other forms of interaction

Section updated in line with CDS on the half-life of trastuzumab and effect on cardiac function.

 

4.6. Fertility, pregnancy and lactation

Section updated in line with QRD Version 9

4.8    Undesirable effects

Section updated in line with QRD Version 9

5.1       Pharmacodynamic properties

Section updated in line with QRD Version 9

6.6       Special precautions for disposal and other handling

Section updated in line with QRD Version 9

Reasons for adding or updating:

  • 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

Date of revision of text on the SPC:01-10-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



sections 4.4 (Special warnings and precautions for use) and 4.5 (Interaction with other medicinal products and other forms of interaction).

Reasons for adding or updating:

  • 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

Date of revision of text on the SPC:01-07-2009

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

SPC
4.3 Contraindications: reorganisation and rewording of text and addition of new contraindications:
Hypersensitivity to epirubicin, other components of the product, other anthracyclines or anthracenediones
Lactation
Additional contraindications for intravenous use:
Severe hepatic impairment
Severe myocardial insufficiency
Recent myocardial infarction
Severe arrhythmias
Previous treatment with anthracenediones
Acute systemic infections
Unstable angina pectoris
Myocardiopathy
Additional contraindications for intravesical use:
Urinary tract infections
Bladder inflammation
Hematuria
Invasive tumours penetrating the bladder
Catheterisation problems

4.4 Warnings and precautions: addition of new warnings/precautions on the following topics:
Patients should recover from acute toxicities of prior cytotoxic treatment before beginning treatment with epirubicin
Adverse events associated with treatment with high doses of epirubicin
Cardiac function
Early (acute) cardiac events
Late (delayed) cardiac events
Risk of developing CHF
Assessment and monitoring of cardiac function before and during epirubicin therapy
Risk factors for cardiac toxicity
Haematologic toxicity
Secondary leukaemia
Gastrointestinal adverse events
Liver function
Renal function
Effects at site of injection
Extravasation
Thrombophlebitis and thromboembolic phenomena, including pulmonary embolism
Tumor-lysis syndrome
Immunosuppressant effects/increased susceptibility to infections
Reproductive system
Additional warnings and precautions for intravesical and intra-arterial route of administration
Adverse effects of excipients

4.5 Interactions (including interactions with other medicinal products) added, including the following topics:
Additive toxicity when epirubicin is used in combination with other cytotoxic/potentially cardiotoxic drugs, or other cardioactive compounds
Concomitant therapies that affect hepatic function
Vaccinations
Cimetidine to be discontinued during treatment with epirubicin
Prior use and coadministration (with epirubicin) of paclitaxel or docetaxel
Interaction with dexverapamil
Interaction with quinine
Coadministration of interferon alpha-2b
(Pre)treatment with medications that influence the bone marrow

4.6 Information added regarding fertility impairment and lactation, and information on pregnancy updated

4.8 Further undesirable effects added and section reorganised to include additional details of undesirable effects and their frequencies, in the following categories:
Infections and infestations
Neoplasms, benign, malignant and unspecified (incl cysts and polyps)
Blood and the lymphatic system disorders
Immune system disorders
Metabolism and nutrition disorders
Nervous system disorders
Eye disorders
Cardiac disorders
Vascular disorders
Gastrointestinal disorders
Skin and subcutaneous tissue disorders
Renal and urinary disorders
Reproductive system and breast disorders
General disorders and administration site conditions
Investigations
Injury, poisoning and procedural complications
Intravesical administration

4.9 Signs, symptoms and treatment of overdose updated to add new details, including gastrointestinal toxic effects, a longer latency period for cardiac failure after completion of treatment, and treatment of overdose.

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 (date of (partial) revision of the text

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 (date of (partial) revision of the text

Reasons for adding or updating:

  • Change to section 6. 3 - Shelf Life

Reasons for adding or updating:

  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC