Methotrexate 50 mg/2 ml Injection

Product Information *

  • Company:

    Pfizer Healthcare Ireland
  • Status:

    No Recent Update
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 01 March 2021

File name

DEC202113658_Reg PIL IE gxME 16_0 Inj 50mg-2ml-clean_1614602061.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 28 September 2020

File name

Reg SPC IE gxME 12_1 Inj 50mg-2ml-clean_1601285320.pdf

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 28 September 2020

File name

Reg PIL IE gxME 14_1 Inj 50mg-2ml-clean_1601285277.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 23 December 2019

File name

Reg PIL IE gxME 13_1 Inj 50mg-2ml_clean_1577095617.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 3 - dose and frequency
  • Change to section 6 - date of revision

Updated on 20 December 2019

File name

DEC201972132_Reg SPC IE gxME 11_2 Inj 50mg-2ml_clean_1576855458.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 20 December 2019

File name

DEC201972132_Reg PIL IE gxME 12_1 Inj 50mg-2ml_clean_1576855352.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 3 - dose and frequency
  • Change to section 6 - date of revision

Updated on 14 November 2019

File name

Reg SPC gxME 10_1 Inj 50mg-2ml-c_1573741034.pdf

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

To update section 4.5 of the SmPC as per PRAC recommendations (EMEA/H/C/PSUSA/00002014/201810). To update the interaction of methotrexate with nitrous oxide

Updated on 14 November 2019

File name

Reg PIL IE gxME 12_1 Inj 50mg-2ml-c_1573740509.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 6 - date of revision

Updated on 01 November 2018

File name

Reg PIL IE gxME 10_0 Inj 50mg-2ml_clean_1541063957.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects

Updated on 01 November 2018

File name

Reg SPC gxME 9_0 Inj 50mg-2ml_clean_1541064039.pdf

Reasons for updating

  • 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

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Please update eMC / medicines.ie

The SPC has been updated as per the PRAC recommendations. The following sections have been updated: 4.2, 4.3, 4.4, 4.5, 4.6, 4.8 and 4.9

 

Updated on 01 October 2018

File name

Reg SPC gxME 8_1 Inj 50mg-2ml_clean_1538141320_1538391988.pdf

Reasons for updating

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

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: Section 7 has been updated from Current MAH to Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland. Subsequently section 8 has also been updated with the HPRA newly appointed Marketing Authorisation number.

Updated on 28 September 2018

File name

Reg PIL IE gxME 9_0 Inj 500mg-20ml_clean_1538142074.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 28 September 2018

File name

Reg SPC gxME 8_1 Inj 50mg-2ml_clean_1538141320.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: Section 7 has been updated from Current MAH to Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland. Subsequently section 8 has also been updated with the HPRA newly appointed Marketing Authorisation number.

Updated on 18 September 2018

File name

Reg PIL IE gxME 8_0 Inj 50mg-2ml_clean_1537170614.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 09 August 2018

File name

Reg SPC gxME 7_0 Inj 50mg-2ml_clean_1533803412.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

SPC impacted only.

Section 4.4 – updated to include reference to Thoracic pain.

Updated on 01 May 2018

File name

Reg_SPC_gx_ME_5_0_Inj_50mg_2ml_clean.docx

Reasons for updating

  • 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

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4 and 4.8 updates with details of pulmonary alveolar haemorrhage

Section 10-  update date of revision of text to 04/2018 to reflect submission date and internal reference number updated.

Updated on 26 April 2018

File name

Reg PIL IE gxME 5_0 Inj 50mg-2ml_clean.pdf

Reasons for updating

  • 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

Updated on 24 April 2018

File name

Reg_SPC_gxME_5_0_Inj_50mg_2ml_clean.docx

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4 and 4.8 updates with details of pulmonary alveolar haemorrhage

Section 10-  update date of revision of text to 04/2018 to reflect submission date and internal reference number updated.

Updated on 23 January 2018

File name

PIL_17061_156.pdf

Reasons for updating

  • New PIL for new product

Updated on 23 January 2018

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 16 August 2017

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 19 January 2017

Reasons for updating

  • New PIL for medicines.ie