Last Updated on eMC 12-07-2018 View medicine  | Merck Sharp & Dohme 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 4.2 - Posology and method of administration
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects - how to report a side effect

Date of revision of text on the SPC:29-06-2018

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.2 – Posology and method of administration:  

Corrigendum to correct posology to clarify that the contraindication is for patients with moderate to severe hepatic impairment. “Moderate to severe” added under the heading “Hepatic impairment “:

 

Hepatic impairment

There is no experience on the use of Orgalutran in subjects with hepatic impairment, as they were excluded from clinical studies. Therefore, the use of Orgalutran is contraindicated in patients with moderate or severe hepatic impairment (see section 4.3).

  

Section 4.8 – Undesirable Effects:  

AE reporting details updated

 

Section 7 – Marketing Authorisation Holder:  

Changed to Merck Sharp & Dohme B.V. Waarderweg 39 2031 BN Haarlem The Netherlands

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.8 - Undesirable effects - how to report a side effect

Date of revision of text on the SPC:28-04-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 2 – Qualitative and quantitative composition: the following relating to sodium content has been added from section 4.4:

Section 4.2 – Posology and method of administration

-Addition of new sub-heading “Special populations” before information related to hepatic and renal impairment. Information related to hepatic and renal impairment is split into two distinct paragraphs (no new information). The information related to the paediatric population has been moved to the end of the hepatic impairment sub-section

Section 4.4 – Special warnings and precautions for use

-Addition of the following sub-headings: “Hypersensitivity reaction”, “Latex allergy”, “Ovarian hyperstimulation syndrome (OHSS)”, “Ectopic pregnancy”, “Congenital malformations”, “Women weighing less than 50 kg or more than 90 kg”

Section 4.8 – Undesirable effects:

-Addition of the following sub-headings: “Summary of the safety profile”, “Tabulated list of adverse reactions”, “Description of selected adverse reactions”. Adverse reactions are now presented in a table, instead of a list. Addition of the paragraph related to the reporting of suspected adverse reactions.

Other: ml” has been replaced by “mL” throughout the text. Section 4.1 indication modified to include ‘Orgalutran is indicated for’. Section 4.6 the information related to fertility has been moved to the end of this section

 

Reasons for adding or updating:

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:19-09-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



MAH updated to:
Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

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 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:10-09-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



  • Sections 4.4, 4.8 and 6.5 have been updated to include safety information related to allergic reactions that maybe caused by the natural rubber latex in the packaging of Orgalutran

 

  • The SmPC has alson been updated according to the QRD template v8

 

  • The revision date has been changed to 10 September 2012

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:27-01-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



- Update of section 4.8 of the SmPC following the approval of EMEA/H/C/0274/FUM25 showing a similar safety profile for Orgalutran, whether started on day 5 or day 6 of an ovarian stimulation protocol for assisted reproduction techniques.

- As a consequence of the marketing approval of the sustained follicle stimulant corifollitropin alfa (trade name Elonva) in the EU for Controlled Ovarian Stimulation, the MAH has added this product to the product information for Orgalutran where relevant.

Reasons for adding or updating:

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

Date of revision of text on the SPC:11-11-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 6.3 Shelf life has been updated from 2 years to 3 years.

Section 10 Date of Revision has been updated.

Reasons for adding or updating:

  • 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 4.8 - 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. 3 - Shelf Life
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • 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

Date of revision of text on the SPC:10-05-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



  • Editorial changes replacing the words "trials" and "patients" with "studies" and "women", and the inclusion of the word "medicinal" in front of "product"
  • The following updates to section 4.2 (Posology and method of administration), including two new sub headings, "Timing of last injection" and "Paediatric population". A statement confirming the use of Orgalutran is contraindicated in patients with moderate and severe renal or hepatic impairment
  • Editorial change of text from "lactation" to "breast-feeding" in section 4.3 (Contraindications)
  • The addition of a statement confirming that Orgalutran is "essentially sodium-free", in section 4.4 (Special warnings and precautions for use).
  • An update to section 4.6 (Fertility, pregnancy and lactation), that includes formatting changes and the addition of three new sub headings, "Fertility", "Pregnancy" and "Breast-feeding". The following new paragraph under the sub heading, “Fertility" has been added, "Ganirelix is used in the treatment of women undergoing controlled ovarian hyperstimulation in assisted reproduction programmes.  Ganirelix is used to prevent premature LH surges that might otherwise occur in these women during ovarian stimulation"
  • Section 4.8 (Undesirable effects) has been reformatted according to the MedDRA system organ class and frequency.  There is no change in the adverse effects.
  • The following statement has been added to section 4.9 (Overdose), "In case of overdose, Orgalutran treatment should be (temporarily) discontinued"
  • The pharmacotherapeutic group definition now includes "Pituitary and hypothalamic hormones and analogues" in section 5.1 (Pharmacodynamic properties).