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Centralised Authorizations in Europe - New Medicinal Products

In the European Union marketing authorization is provided for innovative medicines in all European member states by the European Commission via the centralized procedure coordinated by the European Medicines Agency.

In these centralized authorization procedures, the Paul-Ehrlich-Institut took on the role of rapporteur or co-rapporteur for the following medicines.

License DateMedicinal ProductFurther Information
17.09.2018Ilumetri is a medicine that acts on the immune system and is used to treat plaque psoriasis, a disease causing red, scaly patches on the skin. It is used in adults with moderate to severe disease for whom treatments applied to the skin are not suitable.
Ilumetri contains the active substance tildrakizumab.

EPAR

All information about Ilumetri (EMA)

31.08.2018Veyvondi is a medicine used to control bleeding in patients with von Willebrand disease (an inherited bleeding disorder), who cannot be treated with another medicine called desmopressin or when desmopressin is ineffective. It is used "on demand" to treat bleeding episodes and is also used to prevent and treat bleeding during surgery. Veyvondi contains the active substance vonicog alfa.

EPAR

All information about Veyvondi (EMA)

22.08.2018

Yescarta is a medicine for treating two types of blood cancer:

  • diffuse large B-cell lymphoma (DLBCL);
  • primary mediastinal large B-cell lymphoma (PMBCL).

Yescarta is for adult patients whose blood cancer has returned or has stopped responding to previous treatment.

EPAR

All information about Yescarta (EMA)

26.07.2018

Trazimera is a cancer medicine used to treat the following conditions:

  • early breast cancer (when the cancer has spread within the breast or to the glands under the arm but not to other parts of the body) after surgery, chemotherapy (medicines to treat cancer), and radiotherapy (treatment with radiation) if applicable. It can also be used earlier in treatment, in combination with chemotherapy. For cancers that are locally advanced (including those that are inflammatory) or more than 2 cm wide, Trazimera is used before surgery in combination with chemotherapy and then again after surgery on its own;
  • metastatic breast cancer (cancer that has spread to other parts of the body). It is used on its own when other treatments have not worked or are not suitable. It is also used in combination with other cancer medicines: with paclitaxel or docetaxel, or with another class of medicines called aromatase inhibitors;
  • metastatic gastric (stomach) cancer, in combination with cisplatin and either capecitabine or fluorouracil (other cancer medicines).

Trazimera can only be used when the cancer "overexpresses HER2": this means that the cancer produces a protein called HER2 in large quantities on the cancer cells. HER2 is overexpressed in about a quarter of breast cancers and a fifth of gastric cancers. Trazimera is a ‘biosimilar medicine’. This means that Trazimera is highly similar to another biological medicine (the "reference medicine") that is already authorised in the EU. The reference medicine for Trazimera is Herceptin. Trazimera contains the active substance trastuzumab.

EPAR

All information about Trazimera (EMA)

26.07.2018Ubac is a vaccine used in cows and heifers (female cattle that have not yet calved) to reduce clinical mastitis (udder infections with visible signs in milk or the udder) caused by bacteria called Streptococcus uberis, which can reduce milk production. Ubac is also used to reduce the somatic cell count (SCC) in milk, which is a measure of mastitis without visible signs (subclinical mastitis). Ubac contains the active substance called biofilm adhesion component including lipoteichoic acid, which is derived from the sticky film produced by Streptococcus uberis strain 5616.

EPAR

All information about Ubac (EMA)

18.05.2018

Kanjinti is a cancer medicine used to treat the following conditions:

  • early breast cancer (when the cancer has spread within the breast or to the glands under the arm but not to other parts of the body) after surgery, chemotherapy (medicines to treat cancer), and radiotherapy (treatment with radiation) if applicable. It can also be used earlier in treatment, in combination with chemotherapy. For cancers that are locally advanced (including those that are inflammatory) or more than 2 cm wide, Kanjinti is used before surgery in combination with chemotherapy and then again after surgery on its own;
  • metastatic breast cancer (cancer that has spread to other parts of the body). It is used on its own when other treatments have not worked or are not suitable. It is also used in combination with other cancer medicines: with paclitaxel or docetaxel, or with another class of medicines called aromatase inhibitors;
  • metastatic gastric (stomach) cancer, in combination with cisplatin and either capecitabine or fluorouracil (other cancer medicines).


Kanjinti can only be used when the cancer "overexpresses HER2": this means that the cancer produces a protein called HER2 in large quantities on the cancer cells. HER2 is overexpressed in about a quarter of breast cancers and a fifth of gastric cancers. Kanjinti is a "biosimilar medicine". This means that Kanjinti is highly similar to another biological medicine (the "reference medicine") that is already authorised in the EU. The reference medicine for Kanjinti is Herceptin. Kanjinti contains the active substance trastuzumab.

EPAR

All information about Kajinti (EMA)

21.03.2018Shingrix is a vaccine used to protect adults aged 50 years and over against shingles (herpes zoster) and post-herpetic neuralgia (long-lasting nerve pain following shingles).

EPAR

All information about Shingrix (EMA)

09.02.2018

Herzuma is a cancer medicine used to treat the following conditions:

  • early breast cancer (when the cancer has spread within the breast or to the glands under the arm but not to other parts of the body) after surgery, chemotherapy (medicines to treat cancer), and radiotherapy (treatment with radiation) if applicable. It can also be used earlier in treatment, in combination with chemotherapy. For tumours that are locally advanced (including those that are inflammatory) or more than 2 cm wide, Herzuma is used before surgery in combination with chemotherapy and then again after surgery on its own;
  • metastatic breast cancer (cancer that has spread to other parts of the body). It is used on its own in patients in whom previous treatments have failed. It is also used in combination with other cancer medicines: with paclitaxel or docetaxel, or with another class of medicines called aromatase inhibitors;
  • metastatic gastric (stomach) cancer, in combination with cisplatin and either capecitabine or fluorouracil (other cancer medicines).


Herzuma can only be used when the cancer has been shown to "overexpress HER2": this means that the cancer produces a protein called HER2 in large quantities on the surface of the tumour cells. HER2 is overexpressed in about a quarter of breast cancers and a fifth of gastric cancers. Herzuma is a "biosimilar medicine". This means that Herzuma is similar to another biological medicine (the "reference medicine") that is already authorised in the European Union (EU). The reference medicine for Herzuma is Herceptin. Herzuma contains the active substance trastuzumab.

EPAR

All information about Herzuma (EMA)

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