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Macugen (pegaptanib) – Conditions or restrictions regarding supply and use - S01LA03

Updated on site: 08-Oct-2017

Medication nameMacugen
ATC CodeS01LA03
Substancepegaptanib
ManufacturerPharmaSwiss Ceska Republika s.r.o

A.MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

Pfizer Manufacturing Belgium NV,

Rijksweg 12

B-2870 Puurs

Belgium

B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION

Periodic Safety Update Reports

The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT

Risk Management Plan (RMP)

The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.

An updated RMP should be submitted:

At the request of the European Medicines Agency;

Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.

If the submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.

Additional risk minimisation measures

Prior to launch in each Member State the Marketing Authorisation Holder (MAH) shall agree the final educational material with the National Competent Authority.

The MAH shall ensure that, following discussions and agreement with the National Competent Authorities in each Member State where Macugen is marketed, at launch and after launch all ophthalmological clinics where Macugen is expected to be used are provided with an updated physician information pack containing the following elements:

The Summary of Product Characteristics

Physician safety brochure

Intravitreal injection procedure video

Intravitreal injection procedure pictogram

Patient information

The physician safety brochure should contain the following key elements:

a)The intravitreal procedure as it was performed in the pivotal clinical studies, along with any technical improvements

b)Use of povidone iodine

c)Performing lid scrubs

d)Use of anaesthetic to ensure patient comfort

e)Sterile techniques to minimize the risk of infection

f)Use of antibiotics

g)Techniques for the intravitreal injection

h)Key signs and symptoms of intravitreal injection related adverse events including endophthalmitis, increased intraocular pressure, retinal injury, intraocular haemorrhage, traumatic cataract, hypersensitivity and injection of excess volume

i)Management of intraocular pressure

j)Management of endophthalmitis

k)Understanding the risk factors involved in developing endophthalmitis

l)Reporting of serious adverse events(reminder aid)

The patient information should contain the following key elements:

m)Key signs and symptoms of serious adverse events associated with the intravitreal injection procedure including endophthalmitis, increased intraocular pressure, retinal injury, intraocular haemorrhage, traumatic cataract, hypersensitivity and injection of excess volume

n)When to seek urgent attention from the health care provider

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